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biotecMAX™ January/ February/March/April 2021 Insight
KEYTRUDA® (pembrolizumab)
Merck’s KEYTRUDA® (pembrolizumab) Demonstrated Superior Disease-Free Survival (DFS) Compared With Placebo as Adjuvant Therapy in Patients With Renal Cell Carcinoma (RCC) Following Surgery
April 8, 2021 6:45 am ET
Phase 3 Data from KEYNOTE-564 to be Presented at Upcoming Medical Meeting and Submitted to Regulatory Authorities
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-564 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, met its primary endpoint of disease-free survival (DFS) for the potential adjuvant treatment of patients with renal cell carcinoma (RCC) following nephrectomy (surgical removal of a kidney) or following nephrectomy and resection of metastatic lesions. Based on an interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA monotherapy demonstrated a statistically significant and clinically meaningfully improvement in DFS compared with placebo. The trial will continue to evaluate overall survival (OS), a key secondary endpoint. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies. Results will be presented at an upcoming medical meeting and will be submitted to regulatory authorities.
“Since its first approval in renal cell carcinoma nearly two years ago, KEYTRUDA has become an important first-line treatment option in combination with axitinib for patients with advanced renal cell carcinoma,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “These new data are the result of our research to evaluate the role of KEYTRUDA in helping patients with earlier stages of disease and are the first positive results for an anti-PD-1 therapy in the adjuvant treatment of patients with renal cell carcinoma. We look forward to sharing results of KEYNOTE-564 with the medical community and regulatory authorities as soon as possible.”
KEYTRUDA is currently approved in the U.S., Europe and Japan in combination with axitinib for the first-line treatment of patients with advanced RCC. Merck is continuing to study KEYTRUDA as monotherapy and in combination with other cancer treatments across multiple settings and stages of RCC through its broad clinical program.
About KEYNOTE-564
KEYNOTE-564 is a randomized, double-blind, Phase 3 trial (ClinicalTrials.gov, NCT03142334 ) evaluating KEYTRUDA monotherapy for the adjuvant treatment of patients with RCC who have undergone nephrectomy and who have intermediate-high risk, high risk, or M1 no evidence of disease (M1 NED) RCC with clear cell component. The study enrolled 950 patients who were randomized to receive either KEYTRUDA (200 mg intravenously [IV] on Day 1 of each three-week cycle for up to 17 cycles) or placebo (saline solution IV on Day 1 of each three-week cycle for up to 17 cycles). The primary endpoint is DFS, and the secondary endpoints include OS and safety.
About KEYTRUDA® (pembrolizumab) Injection, 100 mg
KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,400 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.
Selected KEYTRUDA® (pembrolizumab) Indications in the U.S.
Melanoma
KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.
KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
Non-Small Cell Lung Cancer
KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
Head and Neck Squamous Cell Cancer
KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) ≥1] as determined by an FDA-approved test.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
Classical Hodgkin Lymphoma
KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.
Primary Mediastinal Large B-Cell Lymphoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.
Urothelial Carcinoma
KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (CPS ≥10), as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
Microsatellite Instability-High or Mismatch Repair Deficient Cancer
KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)
- solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or
- colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.
This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.
Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer
KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).
Gastric Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Esophageal Cancer
KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:
- in combination with platinum- and fluoropyrimidine-based chemotherapy, or
- as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD L1 (CPS ≥10) as determined by an FDA approved test
Cervical Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Hepatocellular Carcinoma
KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Merkel Cell Carcinoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Renal Cell Carcinoma
KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
Tumor Mutational Burden-High
KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.
Cutaneous Squamous Cell Carcinoma
KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.
Triple-Negative Breast Cancer
KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
For more information, visit www.merck.com
Please see Prescribing Information for KEYTRUDA (pembrolizumab) at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf and Medication Guide for KEYTRUDA at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210408005138/en/
Merck’s Keytruda succeeds in late-stage trial as monotherapy in kidney cancer
Apr. 08, 2021 2:00 PM ETMerck & Co., Inc. (MRK)By: Dulan Lokuwithana, SA News Editor7 Comments
- Merck (MRK -0.3%) says that its anti-PD-1 therapy Keytruda reached the primary endpoint of disease-free survival (“DFS”) in a pivotal Phase 3 trial as a potential adjuvant treatment of a specific category of patients with renal cell carcinoma (“RCC”).
- https://seekingalpha.com/news/3680476-mercks-keytruda-succeeds-in-late-stage-trial-as-monotherapy-in-kidney-cancer
- https://seekingalpha.com/symbol/MRK
XIENCE™ STENT
ABBOTT'S XIENCE™ STENT RECEIVES EUROPEAN APPROVAL FOR ONE-MONTH DUAL ANTI-PLATELET THERAPY (DAPT) FOR HIGH BLEEDING RISK PATIENTS- New shorter duration of dual anti-platelet therapy (DAPT) post XIENCE stent implant provides physicians with additional options to treat patients at high risk of bleeding- XIENCE is the most used drug eluting stent in the world, and European approval for shorter DAPT is supported by two studies that demonstrated safe treatment of stented patients with one-month or three-month use of DAPT- Recent data demonstrate XIENCE with short DAPT does not increase cardiac events and reduces severe bleeding, further confirming the leading safety profile of the XIENCE stent
ABBOTT PARK, Ill., April 6, 2021 /PRNewswire/ -- Abbott (NYSE: ABT) today announced its XIENCE stent has received CE Mark in Europe for shorter duration of dual anti-platelet therapy (DAPT) – as short as 28 days, the shortest indication available in the world – for patients with high bleeding risk (HBR). The approval follows recent results from two studies that demonstrated both one-month or three-month DAPT followed by aspirin monotherapy is safe in HBR patients and is intended to improve patient outcomes and provide physicians more options to treat their patients. XIENCE is the most widely used stent worldwide and is the only stent to have evidence and data for both one-month and three-months DAPT followed by two different types of blood-thinning medication in HBR patients.
Patients who receive stents are typically on DAPT regimens (aspirin and antiplatelet drugs known as P2Y12 inhibitors to prevent blood clots) for six to 12 months to support vessel healing and prevent clotting from blocking the stented vessel. However, HBR patients can experience side effects such as bleeding during prolonged courses of DAPT. Abbott's XIENCE 28 and XIENCE 901 studies show that DAPT can be safely discontinued early – as short as 28 days – with no increased risk in patient adverse events, further confirming the industry-leading safety profile of the XIENCE stent.
"The results of the studies examining the XIENCE stent in high bleeding risk patients with shorter durations of dual anti-platelet therapy were highly consistent – with no increase in cardiac events and significant reduction in severe bleeding. To see such consistency is important for physicians seeking the best possible outcome for our patients," says Marco Valgimigli, M.D., Ph.D., deputy chief of CardioCentro Ticino, Lugano, Switzerland and professor of cardiology at the University of the Italian Switzerland (USI).
Connect with us at www.abbott.com
Abbott's XIENCE stent indication gets European approval
Apr. 06, 2021 9:21 AM ETAbbott Laboratories (ABT)By: Aakash Babu, SA News Editor2 Comments
- Abbott (NYSE:ABT) announces that its XIENCE stent has received CE Mark in Europe for shorter duration of dual anti-platelet therapy (DAPT) – as short as 28 days, the shortest indication available in the world – for patients with high bleeding risk (HBR).
- https://seekingalpha.com/news/3679499-abbotts-xience-stent-indication-gets-european-approval
- https://seekingalpha.com/symbol/ABT
- https://www.cardiovascular.abbott/int/en/hcp/products/percutaneous-coronary-intervention/xience-family/xience-trial-results.html
Tisotumab Vedotin
Seagen and Genmab Announce U.S. FDA Filing Acceptance for Priority Review of Tisotumab Vedotin Biologics License Application for Patients with Recurrent or Metastatic Cervical Cancer
04/09/2021
- FDA Action Date is October 10, 2021 -
- BLA Submission Supported by Positive Pivotal innovaTV 204 Trial Results Presented at the European Society of Medical Oncology Virtual Congress 2020 -
BOTHELL, Wash. & COPENHAGEN, Denmark--(BUSINESS WIRE)-- Seagen Inc. (Nasdaq: SGEN) and Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) seeking accelerated approval for tisotumab vedotin. This BLA requests FDA approval of tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of October 10, 2021. Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) directed to tissue factor (TF), a cell-surface protein expressed on multiple solid tumors including cervical cancer, and is associated with tumor growth, angiogenesis, metastasis and poor prognosis.1
“The FDA’s filing of the tisotumab vedotin BLA with Priority Review marks an important step forward for this ADC as a potential treatment for patients with recurrent or metastatic cervical cancer,” said Roger Dansey, M.D., Chief Medical Officer at Seagen. “We are collaborating closely with the FDA throughout the review process to make this important therapy available to patients.”
About the innovaTV 204 Trial
The innovaTV 204 trial (also known as GCT1015-04 or innovaTV 204/GOG-3023/ENGOT-cx6) is an ongoing single-arm, global, multicenter study of tisotumab vedotin for patients with recurrent or metastatic cervical cancer who were previously treated with doublet chemotherapy with or without bevacizumab. Additionally, patients were eligible if they had received up to two prior lines of therapy in the recurrent or metastatic setting. In the study, 101 patients were treated with tisotumab vedotin at multiple centers in the U.S. and Europe. The primary endpoint of the trial was confirmed objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by independent central review. Key secondary endpoints included duration of response, progression-free survival, overall survival, safety and tolerability.
The study was conducted by Genmab in collaboration with Seagen, European Network of Gynaecological Oncological Trial Groups (ENGOT) and the Gynecologic Oncology Group (GOG) Foundation. For more information about the phase 2 innovaTV 204 clinical trial and other clinical trials with tisotumab vedotin, please visit www.clinicaltrials.gov.
About Tisotumab Vedotin
Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) composed of Genmab’s fully human monoclonal antibody specific for tissue factor and Seagen’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody and releases it upon internalization, inducing target cell death. In cancer biology, tissue factor is a cell-surface protein and associated with tumor growth, angiogenesis, metastasis and poor prognosis.1 Based on its elevated expression in multiple solid tumors and its rapid internalization, tissue factor was selected as a target for an ADC approach. Tisotumab vedotin is being co-developed by Genmab and Seagen, under an agreement in which the companies share all costs and profits for the product on a 50:50 basis.
Tisotumab vedotin is being evaluated in a global phase 3, randomized clinical trial called innovaTV 301 versus investigator’s choice of chemotherapy in recurrent or metastatic cervical cancer. The primary endpoint is overall survival and secondary endpoints include progression-free survival, duration of response, objective response rate, safety and tolerability. Enrollment is ongoing and the study is intended to support global registrations. In addition, tisotumab vedotin is being evaluated in ongoing clinical trials as monotherapy in recurrent or metastatic cervical cancer, ovarian cancer, and other solid tumors and in combination with commonly used therapies in recurrent or metastatic cervical cancer. These trials are evaluating tisotumab vedotin on a weekly or every three-week dosing schedule. More information about the innovaTV 301 clinical trial, including enrolling sites, as well as other ongoing clinical trials is available at www.clinicaltrials.gov.
For more information on our marketed products and robust pipeline, visit www.seagen.com
For more information, please visit Genmab.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210409005444/en/
FDA accepts Genmab, Seagen's tisotumab vedotin BLA application for review
Apr. 09, 2021 4:14 PM ETSeagen Inc. (SGEN)By: Aakash Babu, SA News Editor
- Genmab A/S (OTCPK:GNMSF) and Seagen (NASDAQ:SGEN) announces that the U.S. FDA has accepted for Priority Review the Biologics License Application (BLA) seeking accelerated approval for tisotumab vedotin.
- https://seekingalpha.com/news/3680798-fda-accepts-genmab-seagens-tisotumab-vedotin-bla-application-for-review
- https://seekingalpha.com/symbol/GNMSF
- https://seekingalpha.com/symbol/SGEN
OPDIVO® (nivolumab) Plus Chemotherapy
Neoadjuvant Opdivo (nivolumab) Plus Chemotherapy Significantly Improves Pathologic Complete Response in Patients with Resectable Non-Small Cell Lung Cancer in Phase 3 CheckMate -816 Trial
04/10/2021CATEGORY:
Nearly a quarter of patients who received Opdivo plus chemotherapy showed no evidence of cancer cells in tissue removed during surgery vs. 2.2% of patients who received chemotherapy alone
Opdivo-based therapies have now demonstrated positive results in Phase 3 trials in earlier stages of four different types of cancer: non-small cell lung cancer, esophageal/gastroesophageal junction cancer, bladder cancer and melanoma
Data selected for an oral presentation in a Clinical Trials Plenary Session at the American Association for Cancer Research Annual Meeting 2021
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced results from the CheckMate -816 study, which showed that neoadjuvant treatment with three cycles of Opdivo (nivolumab) plus chemotherapy significantly improved pathologic complete response (pCR), a primary endpoint, compared to chemotherapy alone in patients with resectable stage Ib to IIIa non-small cell lung cancer (NSCLC). In the study, 24% of patients treated with Opdivo plus chemotherapy prior to surgery achieved pCR, compared to 2.2% of patients treated with chemotherapy alone (Odds Ratio [OR] 13.94, 99% Confidence Interval [CI]: 3.49–55.75; p<0.0001), with pCR defined as no evidence of cancer cells in their resected tissue as assessed by a blinded independent pathology review. Additionally, Opdivo plus chemotherapy was well tolerated and showed consistent improvements in pCR regardless of PD-L1 expression levels, histologies or stages of disease.
CheckMate -816 represents the first randomized Phase 3 study to show a significant improvement in pathological response with a neoadjuvant immunotherapy combination in patients with resectable NSCLC. The first disclosure of these data will be featured in an oral presentation during the Clinical Trials Plenary Session (Abstract #5218) at the American Association for Cancer Research (AACR) Annual Meeting 2021 on Saturday, April 10, 2021 from 12:30-12:45 p.m. EDT.
“The ultimate goal of treatment in earlier stages of cancer is to prevent the disease from coming back as we work towards a cure for these patients. Unfortunately, even when patients with resectable non-small cell lung cancer undergo surgery, the cancer returns in more than half of patients, and many then die from their disease,” said Nicolas Girard, M.D., professor and head of department, medical oncology, Institut Curie. “The pathologic complete response data from CheckMate -816 give us an early indication of the potential benefit of adding nivolumab to chemotherapy as a neoadjuvant treatment in resectable non-small cell lung cancer, and we hope that these encouraging results eventually translate into improved event-free survival and overall survival for these patients.”
Opdivo plus chemotherapy also demonstrated improvements in key secondary endpoints, including major pathological response (MPR). Four times as many patients treated with Opdivo plus chemotherapy vs. chemotherapy alone achieved MPR (36.9% vs 8.9%; OR 5.70, 95% CI: 3.16-10.26), meaning 10% or less of their tumor cells remained after neoadjuvant therapy.
About CheckMate -816
CheckMate -816 is a Phase 3 randomized, open label, multi-center trial evaluating Opdivo plus chemotherapy compared to chemotherapy alone as neoadjuvant treatment in patients with resectable non-small cell lung cancer. For the primary analysis, 358 patients were randomized to receive either Opdivo 360 mg plus histology-based platinum doublet chemotherapy every three weeks for three doses, or platinum doublet chemotherapy every three weeks for three doses, followed by surgery. The primary endpoints of the trial are pathologic complete response (pCR) and event-free survival (EFS). Key secondary endpoints include overall survival (OS), major pathologic response (MPR) and time to death or distant metastases.
About Opdivo
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.
Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.
In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.
Indications
OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of patients with unresectable or metastatic melanoma.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of patients with intermediate or poor risk advanced renal cell carcinoma (RCC).
OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.
OPDIVO® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab) is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
OPDIVO® (nivolumab) is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
For more information about Bristol Myers Squibb, visit us at BMS.com
https://seekingalpha.com/symbol/BMY
TYSABRI® (NATALIZUMAB)
THE EUROPEAN COMMISSION GRANTS MARKETING AUTHORIZATION FOR NEW SUBCUTANEOUS ADMINISTRATION OF TYSABRI® (NATALIZUMAB) TO TREAT RELAPSING-REMITTING MULTIPLE SCLEROSIS
April 7, 2021 at 7:30 AM EDT
- TYSABRI is a well-established high-efficacy treatment that now provides two routes of administration enabling flexibility to meet patients' individual preferences and needs
- The subcutaneous option provides a shorter administration time and expands access to treatment for patients and physicians beyond the infusion setting
- The approval adds to Biogen’s strong MS portfolio and is part of its leading, innovative work to improve the understanding of optimal clinical outcomes as part of the long-term treatment of patients with MS
CAMBRIDGE, Mass., April 07, 2021 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the European Commission (EC) has granted marketing authorization for a subcutaneous (SC) injection of TYSABRI® (natalizumab) to treat relapsing-remitting multiple sclerosis (MS). The new route of administration offers comparable efficacy and safety to the TYSABRI intravenous (IV) formulation building on the therapy’s long-term data, established clinical benefits and well-characterized safety profile. TYSABRI is the only high-efficacy MS therapy to offer two routes of administration options providing patients and physicians the flexibility to choose the one that best fits their individual needs.
The SC and IV formulations of TYSABRI are dosed 300 mg, every four weeks (Q4W) by a healthcare provider. The SC option expands the clinical settings, beyond infusion centers, where patients can be treated. In addition, the SC formulation is administered in a shorter timeframe compared to the IV formulation and allows physicians to reduce or remove the post-dose observation period for some patients after six doses as clinically appropriate. The addition of the SC administration also offers people living with MS another option at a time when they are being encouraged to discuss considerations around COVID-19 vaccination and their MS treatment with their physicians.1,2
TYSABRI® (NATALIZUMAB)
Approved by the EC in 2006, TYSABRI’s efficacy and safety have been shown through clinical trials and extensive real-world evidence gathered over nearly 15 years. During that time, Biogen has initiated research, through efforts such as the MS PATHS network and TYSABRI Observational program (TOP), that have broadened the clinical data for TYSABRI providing physicians and patients with more information on this established high-efficacy MS therapy with a well-characterized safety profile.
About TYSABRI® (natalizumab)
TYSABRI is a well-established treatment indicated for relapsing forms of multiple sclerosis (MS) in adults that has been proven in clinical trials to slow physical disability progression, reduce the formation of new brain lesions and cut relapses. In the European Union, it is indicated as a single disease modifying treatment (DMT) in adults with highly active relapsing-remitting MS (RRMS) for patients with highly active disease activity despite a full and adequate course of treatment with at least one DMT or patients with rapidly evolving severe RRMS. In the U.S., TYSABRI is indicated as monotherapy for the treatment of patients with relapsing forms of MS. TYSABRI is approved in 80 countries, and approximately 213,000 people worldwide have been treated with TYSABRI, with over 835,000 patient-years of experience, based on clinical trials and prescription data.5
TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), a rare opportunistic viral infection of the brain which has been associated with death or severe disability. Risk factors that increase the risk of PML are the presence of anti-JC virus antibodies, prior immunosuppressant use and longer TYSABRI treatment duration. Patients who have all three risk factors have the highest risk of developing PML. When initiating and continuing treatment with TYSABRI, physicians should consider whether the expected benefit of TYSABRI is sufficient to offset this risk.
TYSABRI also increases the risk of developing encephalitis and meningitis caused by herpes simplex and varicella zoster viruses, and serious, life-threatening and sometimes fatal cases have been reported in the post-marketing setting in MS patients receiving TYSABRI. Clinically significant liver injury, including acute liver failure requiring transplant, has also been reported in the post-marketing setting. Other serious adverse events that have occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g., anaphylaxis), a decrease in lymphocyte counts and infections, including opportunistic and other atypical infections.
For information on TYSABRI prescribing information in the EU, please visit: https://ec.europa.eu/health/documents/community-register/html/h346.htm. Please click here for Important Safety Information, including Boxed Warning, and full Prescribing Information, including Medication Guide for TYSABRI in the U.S., or visit your respective country’s product website.
To learn more, please visit www.biogen.com
Biogen's TYSABRI wins EC approval for multiple sclerosis indication
Apr. 07, 2021 7:41 AM ETBiogen Inc. (BIIB)By: Aakash Babu, SA News Editor1 Comment
- Biogen (NASDAQ:BIIB) announces that the European Commission (EC) has granted marketing authorization for a subcutaneous (SC) injection of TYSABRI (natalizumab) to treat relapsing-remitting multiple sclerosis (MS).
- https://seekingalpha.com/news/3679768-biogens-tysabri-wins-ec-approval-for-multiple-sclerosis-indication
- https://seekingalpha.com/symbol/BIIB
- https://www.tysabri.com/
RINVOQTM (upadacitinib)
April 2, 2021
AbbVie Announces Extension of Review for Supplemental New Drug Application of Upadacitinib for the Treatment of Moderate to Severe Atopic Dermatitis
NORTH CHICAGO, Ill., April 2, 2021 /PRNewswire/ -- AbbVie (NYSE:ABBV), a global research and development-based biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for upadacitinib in the treatment of adults and adolescents with moderate to severe atopic dermatitis. The Prescription Drug User Fee Act (PDUFA) action date has been extended three months to early Q3 2021.
As previously disclosed, AbbVie received an information request from the FDA for an updated assessment of the benefit-risk profile for upadacitinib in atopic dermatitis. AbbVie responded to the request and the FDA has informed AbbVie that, as expected, it requires additional time for a full review of the submission.
"We are confident in the sNDA and continue to work with the FDA to bring upadacitinib to patients living with moderate to severe atopic dermatitis in need of new treatment options," said Michael Severino, M.D., vice chairman and president, AbbVie.
About RINVOQTM (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. In August 2019, RINVOQ received U.S. FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. RINVOQ is approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs; for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs; and for the treatment of active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy. The approved dose for RINVOQ in rheumatoid arthritis is 15 mg. Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.
For more information about AbbVie, please visit us at www.abbvie.com.
FDA extends review of Abbvie's sNDA for Rinvoq in atopic dermatitis
Apr. 02, 2021 10:51 PM ET AbbVie Inc. (ABBV) By: Jonathan M Block, SA News Editor13 Comments
- The FDA is extending the PDUFA data for Abbvie's (NYSE:ABBV) sNDA for the JAK inhibitor Rinvoq (upadacitinib) in moderate to severe atopic dermatitis by three months to Q3 2021.
- https://seekingalpha.com/news/3678991-fda-extends-review-of-abbvie-snda-for-rinvoq-in--atopic-dermatitis
- https://seekingalpha.com/symbol/ABBV
- https://www.abbvie.com/
TRODELVY™ (sacituzumab govitecan-hziy)
April 07, 2021
FDA Approves Trodelvy®, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival
– Trodelvy Significantly Reduced the Risk of Death by 49% Compared with Single-Agent Chemotherapy in the Phase 3 ASCENT Study –
– Trodelvy is Under Regulatory Review in the EU and in the United Kingdom, Canada, Switzerland and Australia as Part of Project Orbis –
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted full approval to Trodelvy® (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. The approval is supported by data from the Phase 3 ASCENT study, in which Trodelvy demonstrated a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death (progression-free survival (PFS)), extending median PFS to 4.8 months from 1.7 months with chemotherapy (HR: 0.43; 95% CI: 0.35-0.54; p<0.0001). Trodelvy also extended median overall survival (OS) to 11.8 months vs. 6.9 months (HR: 0.51; 95% CI: 0.41-0.62; p<0.0001), representing a 49% reduction in the risk of death.
Trodelvy is directed to the Trop-2 receptor, a protein frequently expressed in multiple types of epithelial tumors, including TNBC, where high expression is associated with poor survival and relapse. Prior to the FDA approval of Trodelvy, patients with previously treated metastatic TNBC had few treatment options in this high unmet-need setting. The FDA granted accelerated approval to Trodelvy in April 2020 based on objective response rate and duration of response results in a Phase 1/2 study. Today’s approval expands the previous Trodelvy indication to include treatment in adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Trodelvy (sacituzumab govitecan-hziy)
About Trodelvy
Trodelvy (sacituzumab govitecan-hziy) is a first-in-class antibody and topoisomerase inhibitor conjugate directed to the Trop-2 receptor, a protein frequently expressed in multiple types of epithelial tumors, including metastatic triple-negative breast cancer (TNBC), where high expression is associated with poor survival and relapse.
Trodelvy is also being developed as an investigational treatment for metastatic urothelial cancer, hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER 2-) metastatic breast cancer and metastatic non-small cell lung cancer. Additional evaluation across multiple solid tumors is also underway.
About the ASCENT Study
The Phase 3 ASCENT study, an open-label, active-controlled, randomized confirmatory trial, enrolled more than 500 patients with relapsed/refractory metastatic triple-negative breast cancer (TNBC) who had received two or more prior systemic therapies (including a taxane), at least one of them for metastatic disease. Patients were randomized to receive either Trodelvy or a chemotherapy chosen by the patients’ treating physicians. The primary efficacy outcome was progression-free survival (PFS) in patients without brain metastases at baseline, as measured by a blinded, independent, centralized review using RECIST v1.1 criteria. Additional efficacy measures included PFS for the full population (all patients with and without brain metastases) and overall survival (OS). More information about ASCENT is available at http://clinicaltrials.gov/show/NCT02574455.
Please see full Prescribing Information, including BOXED WARNING.
U.S. Prescribing Information for Trodelvy, including BOXED WARNING, is available at www.gilead.com.
Trodelvy, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.
For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210407006027/en/
Gilead wins full FDA approval for Trodelvy in triple-negative breast cancer
Apr. 08, 2021 7:35 AM ETGilead Sciences, Inc. (GILD)By: Dulan Lokuwithana, SA News Editor4 Comments
- Gilead Sciences (NASDAQ:GILD) has announced that the FDA has granted the full approval for Trodelvy (sacituzumab govitecan-hziy) to treat a certain category of adult patients with unresectable locally advanced or metastatic triple-negative breast https://seekingalpha.com/news/3680249-gilead-wins-full-fda-approval-for-trodelvy-in-triple-negative-breast-cancercancer (“TNBC”).
- https://seekingalpha.com/symbol/GILD
- https://trodelvy.com/
XB002
Exelixis Announces U.S. FDA Accepts Investigational New Drug Application for XB002 in Patients with Advanced Solid TumorsPDF Version
– Promising preclinical data suggest best-in-class potential for XB002, a next-generation tissue factor-targeting antibody-drug conjugate –
– Phase 1 clinical trial expected to begin in Q2 2021 –
ALAMEDA, Calif.--(BUSINESS WIRE)--Apr. 5, 2021-- Exelixis, Inc. (Nasdaq: EXEL) today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug Application (IND) to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of XB002 in patients with advanced solid tumors. As a next-generation tissue factor-targeting antibody-drug conjugate (ADC), XB002 has the potential for an improved therapeutic index and may provide a favorable safety profile compared with earlier-generation tissue factor-targeting ADCs.
“The acceptance of our Investigational New Drug Application for XB002 gets us one step closer to our first biologic entering the clinic and learning more about its potential to help patients with difficult-to-treat cancers,” said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. “Considering XB002’s promising preclinical data and potential differentiation from other tissue factor-targeting antibody-drug conjugates, we look forward to initiating our phase 1 trial in patients with advanced solid tumors.”
XB002 (formerly ICON-2) is an ADC composed of a human monoclonal antibody against tissue factor that is conjugated to a cytotoxic agent. After binding to tissue factor on tumor cells, XB002 is internalized, and the cytotoxic agent is released, resulting in targeted tumor cell death. XB002 is a rationally designed next-generation ADC that leverages proprietary linker-payload technology.
Preclinical data demonstrated that XB002 binds to tissue factor without affecting the coagulation cascade, in contrast with prior therapies in this class. The data also demonstrated encouraging activity of XB002 in multiple solid tumor cancer models and improved tolerability compared with other tissue factor-targeting ADCs. XB002 has shown significant tumor growth inhibition and, in some cases, complete regression. The rational design and preclinical profile of this novel tissue factor-targeting ADC suggest that, if born out in clinical evaluation, XB002 could have an improved therapeutic index and favorable safety profile compared with earlier tissue factor-targeting ADCs.
For more information about Exelixis, please visit www.exelixis.com
FDA accepts Exelixis' XB002 application in advanced solid tumors
Apr. 05, 2021 8:35 AM ETExelixis, Inc. (EXEL)By: Mamta Mayani, SA News Editor
- The FDA has accepted Exelixis' (NASDAQ:EXEL) Investigational New Drug Application (IND) to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of XB002 in patients with advanced solid tumors.
- https://seekingalpha.com/news/3679096-fda-accepts-exelixis-xb002-application-in-advanced-solid-tumors
- https://seekingalpha.com/symbol/EXEL
- https://www.exelixis.com/pipeline/
Sarclisa® (isatuximab-irfc) in combination with carfilzomib and dexamethasone
FDA approves Sarclisa® (isatuximab-irfc) in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma
- Sarclisa regimen reduced risk of disease progression or death by 45% compared to standard of care in patients who had relapsed after one to three prior therapies- While the median progression free survival (PFS) for Sarclisa combination therapy is not yet reached, consistent improvement in PFS is seen across patient subgroups- This is the second FDA approval for Sarclisa in combination with standard of care backbone therapies
PARIS, March 31, 2021 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Sarclisa® (isatuximab-irfc) in combination with carfilzomib and dexamethasone (Kd), for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy.
"In the Phase 3 IKEMA study, the addition of Sarclisa to carfilzomib and dexamethasone reduced risk of disease progression or death by 45%," said Thomas G. Martin, M.D., Associate Director, Myeloma Program, The University of California, San Francisco, Professor of Medicine, Adult Leukemia and Bone Marrow Transplantation Program and co-leader of the Hematopoietic Malignancies Program, Helen Diller Family Comprehensive Cancer Center. "This approval is an important advancement for patients whose disease has relapsed and reinforces the potential for Sarclisa to become a standard of care in relapsed or refractory multiple myeloma."
This marks the second FDA approval for Sarclisa, which is also approved in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with RRMM who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
"Treatment of patients with relapsed or refractory multiple myeloma remains challenging and the prognosis for patients experiencing multiple relapses unfortunately is poor," said Peter C. Adamson, M.D., Global Development Head, Oncology and Pediatric Innovation at Sanofi. "With this approval, Sarclisa is now included in two standard of care regimens for the treatment of patients with multiple myeloma as early as first relapse. Today's milestone further supports our ambition for Sarclisa to become the anti-CD38 of choice for patients with relapsed or refractory multiple myeloma."
Sarclisa® (isatuximab-irfc) in combination with carfilzomib and dexamethasone
About Sarclisa
Sarclisa is a monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a potential target for antibody-based therapeutics such as Sarclisa.
This marks the second FDA approval for Sarclisa since March 2020 and comes more than three months ahead of the FDA's target action date. In February, the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion for a second indication for Sarclisa, in combination with carfilzomib and dexamethasone (Kd), for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. The use of Sarclisa in combination with Kd is not currently approved in the European Union (EU), but the final decision whether to expand the indication is expected from the European Commission in the coming months. In Europe, Sarclisa is indicated in combination with pom-dex for the treatment of adult patients with RRMM who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. Outside of the U.S. and the EU, Sarclisa is approved in Switzerland, Canada, Australia, Japan, Russia, the UAE, South Korea, Taiwan and Brazil in combination with pom-dex for the treatment of certain adults with RRMM.
Sarclisa continues to be evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard and novel treatments across the MM treatment continuum. It is also under investigation for the treatment of other hematologic malignancies and solid tumors. The use of Sarclisa in these additional settings is currently under clinical investigation and its safety and efficacy have not been fully evaluated by any regulatory authority.
IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS
What is SARCLISA?
SARCLISA is a prescription medicine used in combination with:
- The medicines pomalidomide and dexamethasone, to treat adults who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor to treat multiple myeloma.
- The medicines carfilzomib and dexamethasone, to treat adults with multiple myeloma who have already received 1 to 3 lines of treatment and they did not work or are no longer working.
It is not known if SARCLISA is safe and effective in children.
Do not receive SARCLISA if you have a history of a severe allergic reaction to isatuximab-irfc or any of the ingredients in SARCLISA (see the list of ingredients in the full Prescribing Information).
FDA approves Sanofi's Sarclisa for another multiple myeloma indication
Mar. 31, 2021 5:39 PM ET Sanofi (SNY) By: Jonathan M Block, SA News Editor1 Comment
- The FDA has approved Sanofi's (NASDAQ:SNY) Sarclisa (isatuximab) for relapsed or refractory multiple myeloma (RRMM) in combination with Kyprolis (carfilzomib) and dexamethasone.
- https://seekingalpha.com/news/3678341-fda-approves-sanofis-sarclisa-for-another-multiple-myeloma-indication
- htthttps://www.sarclisa.com/ps://seekingalpha.com/symbol/SNY
- https://www.sanofi.us/en/
VIR-7831
Vir Biotechnology Announces New Preclinical Research Demonstrating VIR-7831 Maintains Neutralizing Activity Against the SARS-CoV-2 California Variant
04/05/21 at 8:00 AM EDTPDF Version
– Data add to growing body of pre-clinical evidence demonstrating that VIR-7831 maintains activity against all known circulating variants of concern –
– Plasma from vaccinated individuals and several therapeutic monoclonal antibodies showed a reduction in neutralization potency against the California variant –
SAN FRANCISCO, April 05, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced new preclinical research demonstrating the ability of VIR-7831, the company’s investigational SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus-2) monoclonal antibody (mAb), to maintain its neutralizing activity against a mutation in the receptor binding domain (RBD) of SARS-CoV-2, called L452R, which is found in the California variant (B.1.427/B.1.429). Study results also demonstrate that the L452R mutation reduced both the neutralization potency of plasma from vaccinated and convalescent donors and the neutralization activity of 14 RBD-specific and 10 N-terminal domain (NTD)-specific monoclonal antibodies, including three clinical-stage mAbs. Data were published on April 1, 2021 on bioRxiv, and have been submitted to a peer-reviewed journal for future print publication.
In this new study, researchers at Vir and the University of Washington, report the rapid and exponentially increasing spread of the California variant throughout all 50 states and in 29 additional countries worldwide, and characterize the impact of its three mutations: S13I and W152C in the NTD and L452R in the RBD.
VIR-7831
VIR-7831 is an investigational compound, not approved by the U.S. Food and Drug Administration or any other regulatory authority.
About VIR-7831
VIR-7831 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831, which incorporates Xencor’s Xtend™ technology, also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.
Data from 43 vaccinated donors and nine convalescent donors demonstrated that, in a pseudotyped virus system, the S13I, W152C and L452R mutations reduced the neutralization potency of plasma by three-to-six-fold. In addition, the L452R mutation reduced the neutralization activity of 14 out of 35 RBD-specific mAbs, including three clinical-stage antibodies. Researchers also observed a complete loss of neutralization by all NTD-specific mAbs that is mediated by an unconventional escape mechanism. VIR-7831, which targets a non-receptor binding motif (RBM) epitope, was unaffected by the L452R mutation.
“The rapid increase in frequency of this variant in California and neighboring states and its ability to confer some degree of resistance to vaccines and antibody therapies is concerning,” said David Veesler, Ph.D., associate professor of biochemistry, University of Washington in Seattle. “The reduced sensitivity of this variant to plasma antibodies results from three individual spike mutations that mediate evasion from both RBD (partial) and NTD (total) specific antibodies. Together, these data demonstrate that if we are to combat current and anticipated future variants, there is a critical need for monoclonal antibodies that target invariant regions of the spike protein with the potential for a high barrier to resistance.”
“These data add to the growing body of evidence supporting our rationale for targeting a non-RBM epitope and the potential of VIR-7831 to combat the current variants of concern, including the evasive California variant, either as monotherapy or as a foundational therapy for future combinations,” said George Scangos, Ph.D., chief executive officer of Vir Biotechnology. “We believe VIR-7831 could significantly impact both the trajectory of the pandemic and the outcomes of patients facing the more dire consequences of COVID-19. We look forward to continuing to work with global regulatory authorities to bring VIR-7831 to patients as quickly as possible.”
For more information, please visit www.vir.bio.
Vir Biotechnology posts new preclinical research of VIR-7831 in SARS-CoV-2
Apr. 05, 2021 8:31 AM ETVir Biotechnology, Inc. (VIR)By: Aakash Babu, SA News Editor
- Vir Biotechnology (NASDAQ:VIR) announces new preclinical research demonstrating the ability of VIR-7831, the company’s investigational SARS-CoV-2 monoclonal antibody (mAb), to maintain its neutralizing activity against a mutation in the receptor binding domain (RBD) of SARS-CoV-2.
- https://seekingalpha.com/news/3679092-vir-biotechnology-posts-new-preclinical-research-of-vir-7831-in-sars-cov-2
- https://seekingalpha.com/symbol/VIR
- https://www.vir.bio/pipeline/#focus
AbCellera and Gilead ink new multi-year antibody discovery collaboration
AbCellera and Gilead Sciences Announce New Multi-Year, Multi-Target Antibody Discovery Collaboration
Expanded collaboration includes an eight-target discovery partnership leveraging AbCellera’s entire technology stack, including the Trianni Mouse® and the OrthoMab bispecific platforms
APRIL 1, 2021
VANCOUVER, British Columbia - AbCellera (Nasdaq: ABCL) today announced agreements to expand its collaboration with Gilead Sciences, Inc. (Gilead) including a multi-year, multi-target antibody discovery collaboration and access to AbCellera’s humanized mouse technology, the Trianni Mouse®. Under the financial terms of the agreements, AbCellera will receive an upfront payment and is eligible for milestone payments and royalties based on the development and commercialization of antibodies generated by AbCellera under this collaboration.
Building on the successful completion of the first collaboration together, under the new agreement AbCellera will generate panels of antibodies for up to eight new targets, across multiple indications, selected by Gilead. The expanded collaboration will leverage the full breadth of AbCellera’s technology stack, including the recently added capabilities for sourcing diverse, fully-humanized antibodies using the Trianni Mouse® platform and combining any two antibodies to create native bispecifics using the OrthoMabTM protein engineering platform.
“We are excited to build on the success of the first program and deepen our relationship with the team at Gilead,” said Carl Hansen, Ph.D., CEO and President of AbCellera. “We are particularly pleased to see the value created for our partners by quickly integrating the Trianni Mouse® and OrthoMabTM platforms, which we acquired in second half of 2020.”
AbCellera’s partners benefit from an operating system designed to support many antibody modalities, unlock new targets, and increase the speed and the probability of success of their therapeutic antibody discovery programs. AbCellera’s AI-powered technology stack brings together microfluidics, single cell analysis, machine learning, computation, custom robotics, and automation to compound the power of each step in the discovery process.
About AbCellera Biologics Inc.
AbCellera is a technology company that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. AbCellera partners with drug developers of all sizes, from large pharmaceutical to small biotechnology companies, empowering them to move quickly, reduce cost, and tackle the toughest problems in drug development. For more information, visit www.abcellera.com.
AbCellera and Gilead ink new multi-year antibody discovery collaboration
Apr. 01, 2021 9:32 AM ET AbCellera Biologics Inc. (ABCL)
By: Aakash Babu, SA News Editor5 Comments
- AbCellera (ABCL +3.1%) announces agreements to expand its collaboration with Gilead Sciences including a multi-year, multi-target antibody discovery collaboration and access to the company's humanized mouse technology, the Trianni Mouse.
- https://seekingalpha.com/news/3678573-abcellera-and-gilead-inks-new-multi-year-antibody-discovery-collaboration
- https://seekingalpha.com/symbol/ABCL
- https://seekingalpha.com/symbol/GILD
Tecartus®
April 01, 2021
Kite Submits Supplemental Biologics License Application to U.S. Food and Drug Administration for Tecartus® in Adult Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
-- If Approved, Tecartus Would Be the First and Only CAR T-Cell Therapy Approved for Adult Patients (18 Years and Older) with Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia --
SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD), today announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Tecartus® (brexucabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The sBLA is supported by data from the Phase 1/2 ZUMA-3 trial, which are also being submitted for presentation at an upcoming scientific congress.
In 2017, Tecartus was granted Breakthrough Therapy Designation by the FDA for relapsed or refractory adult B-cell precursor ALL. If approved, Tecartus would become the first and only chimeric antigen receptor (CAR) T-cell therapy approved for adults (≥18 years old) with relapsed or refractory ALL.
Tecartus®
About ZUMA-3
ZUMA-3 is an ongoing international multicenter, registrational Phase 1/2 study in adult patients (≥18 years old) with ALL whose disease is refractory to or has relapsed following standard systemic therapy or hematopoietic stem cell transplantation. The objectives of the study are to evaluate the safety and efficacy of Tecartus in this patient population.
About Tecartus
Tecartus is an autologous, anti-CD19 CAR T cell therapy. Tecartus uses the XLP™ manufacturing process that includes T cell enrichment, a necessary step in certain B-cell malignancies in which circulating lymphoblasts are a common feature. In addition to adult ALL, Tecartus is also currently being evaluated in a Phase 1/2 trial in chronic lymphocytic leukemia (CLL) and pediatric ALL. The use of Tecartus in adult ALL, pediatric ALL and CLL is investigational, and its safety and efficacy have not been established in these cancer types.
Tecartus Indication
Tecartus is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
For more information on Kite, please visit www.kitepharma.com.
For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.
U.S. Prescribing Information for Tecartus including BOXED WARNING, is available at www.kitepharma.com and www.gilead.com.
Kite, the Kite logo, Yescarta, Tecartus, XLP and GILEAD are trademarks of Gilead Sciences, Inc. or its related companies.
For more information on Kite, please visit the company’s website at www.kitepharma.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000. Follow Kite on social media on Twitter (@KitePharma) and LinkedIn.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210401
Gilead submits sBLA for Tecartus for acute lymphoblastic leukemia
Apr. 01, 2021 4:49 PM ET Gilead Sciences, Inc. (GILD) By: Jonathan M Block, SA News Editor8 Comments
- Kite, a Gilead (NASDAQ:GILD) company, has submitted an sBLA to the FDA for Tecartus (brexucabtagene autoleucel) as a treatment for relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
- https://seekingalpha.com/news/3678871-gilead-submits-sbla-for-tecartus-for-acute-lymphoblastic-leukemia
- https://seekingalpha.com/symbol/GILD
OUR PIPELINE
LEADING THE WAY IN CELL THERAPY
Our pipeline of cancer therapies in the areas of cell therapy, immuno-oncology, and targeted therapies includes investigational therapies and next-generation technologies that have the power to transform the way cancer is treated. As we look to the future, we remain focused on advancing technologies that could someday address additional hematological malignancies and solid tumors.
https://www.kitepharma.com/science-medicine/pipeline
biotecMAX™ January/ February/March 2021 Insight
COVID-19 vaccine BNT162b2
PFIZER-BIONTECH ANNOUNCE POSITIVE TOPLINE RESULTS OF PIVOTAL COVID-19 VACCINE STUDY IN ADOLESCENTS
Wednesday, March 31, 2021 - 06:45am
- In participants aged 12-15 years old, BNT162b2 demonstrated 100% efficacy and robust antibody responses, exceeding those reported in trial of vaccinated 16-25 year old participants in an earlier analysis, and was well tolerated
- The companies plan to submit these data to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as soon as possible to request expansion of the Emergency Use Authorization (EUA) and EU Conditional Marketing Authorization for BNT162b2
- The companies also provided an update on the Phase 1/2/3 study of BNT162b2 in children aged 6 months to 11 years
NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that, in a Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, the Pfizer-BioNTech COVID-19 vaccine BNT162b2 demonstrated 100% efficacy and robust antibody responses, exceeding those recorded earlier in vaccinated participants aged 16 to 25 years old, and was well tolerated. These are topline results from a pivotal Phase 3 trial in 2,260 adolescents.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210331005503/en/
COVID-19 vaccine BNT162b2
About the Phase 3 Data from Adolescents 12-15 Years of Age
The trial enrolled 2,260 adolescents 12 to 15 years of age in the United States. In the trial, 18 cases of COVID-19 were observed in the placebo group (n=1,129) versus none in the vaccinated group (n=1,131). Vaccination with BNT162b2 elicited SARS-CoV-2–neutralizing antibody geometric mean titers (GMTs) of 1,239.5, demonstrating strong immunogenicity in a subset of adolescents one month after the second dose. This compares well (was non-inferior) to GMTs elicited by participants aged 16 to 25 years old (705.1 GMTs) in an earlier analysis. Further, BNT162b2 administration was well tolerated, with side effects generally consistent with those observed in participants 16 to 25 years of age.
The companies plan to submit these data to the FDA and EMA for a requested amendment to the Emergency Use Authorization of BNT162b2 and the EU Conditional Marketing Authorization for COMIRNATY® to expand use in adolescents 12-15 years of age as quickly as possible. All participants in the trial will continue to be monitored for long-term protection and safety for an additional two years after their second dose.
Pfizer and BioNTech plan to submit the data for scientific peer review for potential publication.
AUTHORIZED USE IN THE U.S.:
The Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.
For more information, please visit www.BioNTech.de
In addition, to learn more, please visit us on www.Pfizer.com
Pfizer/BioNTech report positive data for COVID-19 shot in adolescents
Mar. 31, 2021 7:18 AM ET Pfizer Inc. (PFE) By: Dulan Lokuwithana, SA News Editor11 Comments
- Announcing top-line results from a Phase 3 trial in adolescents 12 to 15 years of age, Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) said that its COVID-19 vaccine led to 100% efficacy and robust antibody responses exceeding the level recorded in an earlier analysis of 16–25-year-old participants.
- https://seekingalpha.com/news/3677958-pfizerbiontech-report-positive-data-for-covid-19-shot-in-adolescents
- https://seekingalpha.com/symbol/BNTX
- https://seekingalpha.com/symbol/PFE
The Pfizer-BioNTech COVID-19 Vaccine Was Granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA)
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by FDA, but has been authorized for emergency use by FDA under an Emergency Use Authorization to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked soone
https://www.cvdvaccine-us.com/
The finding could pave the way for shots for teens and pre-teens before the next school year.
BioNTech-Pfizer vaccine shows '100% efficacy' for young teens
New clinical trial data shows "topline results" for kids between 12 to 15-years-old, Pfizer and BioNTech said. Vaccinating children will be crucial for stopping the pandemic and helping schools look more normal.
https://www.dw.com/en/covid-biontech-pfizer-vaccine-shows-100-efficacy-for-young-teens/a-57061878
Pfizer Shot Remains More Than 91% Effective After Six Months
Pfizer and BioNTech Confirm High Efficacy and No Serious Safety Concerns Through Up to Six Months Following Second Dose in Updated Topline Analysis of Landmark COVID-19 Vaccine Study
XOSPATA® (gilteritinib)
Astellas' XOSPATA® (gilteritinib) Meets Overall Survival Endpoint in COMMODORE Trial of Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation- Confirmatory Phase 3 trial in China, other countries stopped early due to positive results at planned interim analysis -
TOKYO, March 29, 2021 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced that a Phase 3 confirmatory trial of XOSPATA® (gilteritinib) in patients with relapsed (disease that has returned) or refractory (resistant to treatment) FLT3 mutation-positive (FLT3mut+) acute myeloid leukemia (AML) met its primary endpoint of overall survival (OS) compared to chemotherapy at a planned interim analysis.
COMMODORE is an open-label, randomized study of gilteritinib versus salvage chemotherapy in adult patients who have relapsed or refractory AML in China and other countries. Astellas has stopped enrollment in the trial and patients in the chemotherapy arm will be offered the opportunity to receive gilteritinib.
About the COMMODORE Trial
The Phase 3 COMMODORE trial (NCT03182244) is an open-label, multicenter, randomized study of gilteritinib versus salvage chemotherapy in adult patients who have relapsed or refractory AML in China, as well as in other countries. The primary endpoint of the trial is OS. The study also evaluated safety and determined the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of gilteritinib compared to salvage chemotherapy. Subjects were randomized in a 1:1 ratio to receive gilteritinib (120 mg) or salvage chemotherapy.8
About the ADMIRAL Trial
The Phase 3 ADMIRAL trial (NCT02421939) was an open-label, multicenter, randomized study of gilteritinib versus salvage chemotherapy in adult patients with FLT3mut+ who are refractory to or have relapsed after first-line AML therapy. The co-primary endpoints of the trial were OS and CR/CRh rates; OS was the primary endpoint at the trial's final analysis. The study enrolled 371 patients with relapsed or refractory AML and FLT3mut+ present in bone marrow or whole blood. Subjects were randomized in a 2:1 ratio to receive gilteritinib (120 mg) or salvage chemotherapy.9
About Gilteritinib
Gilteritinib was discovered through a research collaboration with Kotobuki Pharmaceutical Co., Ltd., and Astellas has exclusive global rights to develop, manufacture and commercialize gilteritinib. Gilteritinib is available as XOSPATA® in the U.S., Japan and selected European countries, among others, for the treatment of adult patients who have relapsed or refractory FLT3mut+ AML.10 Gilteritinib is an FMS-like tyrosine kinase 3 (FLT3) inhibitor with demonstrated activity against FLT3-ITD, a common driver mutation that presents with a high burden and poor prognosis, and FLT3-TKD mutations.11
For more information, please visit our website at https://www.astellas.com/en.
Astellas' Xospata meets overall survival endpoint in late-stage blood cancer study
Mar. 30, 2021 6:01 AM ET Astellas Pharma Inc. (ALPMF) By: Mamta Mayani, SA News Editor
- Astellas Pharma (OTCPK:ALPMF) announces that a Phase 3 confirmatory trial of Xospata (gilteritinib) in patients with relapsed or refractory FLT3 mutation-positive acute myeloid leukemia (AML) met its primary endpoint of overall survival (OS) compared to chemotherapy at a planned interim analysis.
- https://seekingalpha.com/news/3677449-astellas-xospata-meets-primary-endpoint-in-late-stage-blood-cancer-https://seekingalpha.com/symbol/ALPMFstudy
EYLEA® (AFLIBERCEPT) INJECTION
March 30, 2021 at 7:04 PM EDT Back
NIH-SPONSORED TRIAL FINDS EYLEA® (AFLIBERCEPT) INJECTION REDUCED VISION-THREATENING COMPLICATIONS BY 68% AFTER TWO YEARS IN DIABETIC RETINOPATHY PATIENTS
TARRYTOWN, N.Y., March 30, 2021 /PRNewswire/ --
Protocol W trial data confirm results from PANORAMA trial showing EYLEA significantly reduced vision-threatening complications and improved anatomic measures of diabetic retinopathy
Although patients' overall vision was similar in the EYLEA and sham groups at two years in Protocol W, a new analysis from PANORAMA shows that delaying EYLEA treatment (sham group) was associated with prolonged periods of vision loss
Two diabetic retinopathy trials (Protocol W and PANORAMA) have now shown the benefit of EYLEA every 16 weeks following an initial dosing period; Regeneron to discuss 16-week dosing interval with U.S. FDA
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced JAMA Ophthalmology has published initial results from the National Institutes of Health-sponsored Protocol W trial assessing EYLEA® (aflibercept) Injection in patients with moderate to severe non-proliferative diabetic retinopathy (NPDR), without center-involved diabetic macular edema (CI-DME). At two years, the primary outcome of the trial showed a 68% reduced risk of developing vision-threatening complications (either proliferative diabetic retinopathy [PDR] or CI-DME with vision loss) in patients who received the EYLEA every-16-weeks dosing regimen. In comparison, patients receiving sham injections were almost five times more likely to experience disease progression requiring EYLEA rescue therapy.
EYLEA® (AFLIBERCEPT) INJECTION
About EYLEA® (aflibercept) Injection
EYLEA® (aflibercept) Injection is a VEGF inhibitor formulated as an injection for the eye. It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PLGF), two growth factors involved in angiogenesis. In the U.S., EYLEA is the market-leading, FDA-approved anti-VEGF treatment for its approved indications and is supported by a robust body of research that includes eight pivotal Phase 3 trials.
About Protocol W
Protocol W is a four-year, randomized, multi-center, controlled Phase 3 trial (n=399 eyes) designed to determine the efficacy of EYLEA compared to sham in preventing vision-threatening complications in high risk patients. The primary outcome at two years was time to development of CI-DME with vision loss or PDR. Key secondary outcomes included development of any PDR or DME criteria based on reading center assessment, as well as development of CI-DME with a ≥10% and ≥25 micron increase in center subfield thickness. Per the trial protocol, Protocol W will continue for another two years, when the second primary outcome will assess visual acuity outcomes between the two groups at four years.
The Clinicaltrials.gov identifier for this trial is NCT02634333. The trial was supported by the National Eye Institute (NEI) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), with funding through the Special Diabetes Program, through a cooperative agreement (EY14231).
INDICATIONS
EYLEA® (aflibercept) Injection 2 mg (0.05 mL) is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR).
For additional information about the company, please visit www.regeneron.com
Please see the full Prescribing Information for EYLEA.
SOURCE Regeneron Pharmaceuticals, Inc.
Regeneron's Eylea reduces vision loss by 68% after two years in diabetic retinopathy
Mar. 31, 2021 3:58 AM ETRegeneron Pharmaceuticals, Inc. (REGN)By: Mamta Mayani, SA News Editor
- JAMA Ophthalmology has published initial results from Protocol W trial assessing Regeneron Pharmaceuticals' (NASDAQ:REGN) EYLEA (aflibercept) Injection in patients with non-proliferative diabetic retinopathy (NPDR), without center-involved diabetic macular edema (CI-DME).
- https://seekingalpha.com/news/3677905-regenerons-eylea-reduces-vision-loss-by-68-after-two-years-in-diabetic-retinopathy
- https://seekingalpha.com/symbol/REGN
- https://eylea.us/
QINLOCK® (Ripretinib)
China NMPA Approves QINLOCK® (Ripretinib) for Treatment of Advanced Gastrointestinal Stromal Tumors (GIST)
March 31, 2021 at 4:57 AM EDTPDF Version
China NMPA approval follows 2020 U.S. FDA approval for the treatment of patients with fourth-line GIST
QINLOCK demonstrated a significant improvement in progression-free survival and a clinically meaningful benefit in overall survival compared to placebo in the pivotal Phase 3 INVICTUS study
QINLOCK approval is the third innovative oncology product approval Zai Lab received in the last 15 months
SHANGHAI, SAN FRANCISCO and WALTHAM, Mass., March 31, 2021 (GLOBE NEWSWIRE) -- Zai Lab (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, and Deciphera Pharmaceuticals (NASDAQ: DCPH), a commercial-stage biopharmaceutical company developing innovative medicines to improve the lives of people with cancer, today announced that the China National Medical Products Administration (NMPA) has approved its New Drug Application (NDA) for QINLOCK® (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumors (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib. QINLOCK targets the broad spectrum of KIT and PDGFRα mutations known to drive GIST.
“We congratulate Zai on gaining this important approval,” said Steve Hoerter, President and Chief Executive Officer of Deciphera. “QINLOCK is a new standard of care for patients with fourth-line GIST, and we’re excited to work with our partner Zai as they deliver this innovative medicine to patients in China.”
“The approval of QINLOCK in China is a significant milestone for the GIST community,” said Dr. Shukui Qin, Chief Physician of Cancer Center, Nanjing Jinling Hospital, Senior Vice President of the Chinese Society of Clinical Oncology. “Many GIST patients, who initially responded to traditional tyrosine kinase inhibitors, ultimately developed tumor progression due to secondary mutations. QINLOCK may potentially alter the treatment landscape for patients in China with GIST.”
“Based on the pivotal Phase 3 INVICTUS study, QINLOCK demonstrated compelling clinical benefit in progression-free and overall survival, and was shown to have a favorable safety profile in treating advanced GIST patients,” said Dr. Lin Shen, Vice President of Clinical Oncology at Beijing Cancer Hospital. “We look forward to making this innovative therapy available to patients as soon as possible.”
Deciphera and Zai Lab are also exploring the use of QINLOCK to treat patients with second-line GIST. Deciphera has completed target enrollment in the Phase 3 INTRIGUE study of QINLOCK in patients with second-line GIST, with top-line results anticipated in the second half of 2021.
QINLOCK® (Ripretinib)
About QINLOCK (ripretinib)
QINLOCK is a switch-control tyrosine kinase inhibitor that was engineered to broadly inhibit KIT and PDGFRα mutated kinases by using a dual mechanism of action that regulates the kinase switch pocket and activation loop. QINLOCK inhibits primary and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18 involved in GIST, as well as the primary exon 17 D816V mutation. QINLOCK also inhibits primary PDGFRα mutations in exons 12, 14, and 18, including the exon 18 D842V mutation, involved in a subset of GIST.
In March 2021, the NMPA approved QINLOCK for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib. In March 2021, the Hong Kong Department of Health approved QINLOCK in Hong Kong for the treatment of adult patients with advanced GIST who have received prior treatment with imatinib, sunitinib, and regorafenib. In May 2020, the U.S. FDA approved QINLOCK for the treatment of adult patients with advanced GIST who received prior treatment with three or more kinase inhibitors, including imatinib. It is also approved by Health Canada for the treatment of adult patients with advanced GIST who have received prior treatment with imatinib, sunitinib, and regorafenib and by the Australian Therapeutic Goods Administration for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib.
Zai Lab has an exclusive license agreement with Deciphera for the development and commercialization of ripretinib in Greater China (mainland China, Hong Kong, Macau and Taiwan).
About the INVICTUS Phase 3 Study
INVICTUS is a Phase 3 randomized, double-blind, placebo-controlled, international, multicenter clinical study evaluating the safety, tolerability, and efficacy of QINLOCK compared to placebo in patients with advanced GIST whose previous therapies have included imatinib, sunitinib, and regorafenib. Patients were randomized 2:1 to either 150 mg of QINLOCK or placebo once daily. The primary efficacy endpoint is progression-free survival (PFS) as determined by independent radiologic review using modified Response Evaluation Criteria in Solid Tumors (RECIST). The median PFS in the study was 6.3 months compared to 1.0 month in the placebo arm and significantly reduced the risk of disease progression or death by 85% (hazard ratio of 0.15, p<0.0001). Secondary endpoints as determined by independent radiologic review using modified RECIST include Objective Response Rate (ORR) and Overall Survival (OS). QINLOCK demonstrated an ORR of 9.4% compared with 0% for placebo (p =0.0504). QINLOCK also demonstrated a median OS of 15.1 months compared to 6.6 months in the placebo arm and reduced the risk of death by 64% (hazard ratio of 0.36).
Indication
What is QINLOCK?
QINLOCK is a prescription medicine used to treat adults with advanced gastrointestinal stromal tumor (GIST) who have received 3 or more prior treatments for their GIST.
Please see complete Prescribing Information, including Patient Information.
For additional information about the company, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab
For more information, visit www.deciphera.com
OUR PIPELINE
https://www.deciphera.com/pipeline/
Zai Lab, Deciphera's Qinlocked OK'd in China for gastrointestinal tumors
Mar. 31, 2021 5:17 AM ET
Zai Lab Limited (ZLAB) By: Mamta Mayani, SA News Editor
- The China National Medical Products Administration (NMPA) has approved Zai Lab (NASDAQ:ZLAB) and Deciphera Pharmaceuticals' (NASDAQ:DCPH) New Drug Application (NDA) for Qinlock (ripretinib) for the treatment of adults with advanced gastrointestinal stromal tumors (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib.
- https://seekingalpha.com/news/3677911-zai-lab-decipheras-qinlocked-okd-in-china-for-gastrointestinal-tumors4
- https://seekingalpha.com/symbol/ZLAB
- https://seekingalpha.com/symbol/DCPH
- https://www.qinlock.com/#isi
Saxenda® (liraglutide 3.0 mg)
Saxenda® recommended for approval by European Medicines Agency committee for the treatment of obesity in adolescents aged 12–17 years
Bagsværd, Denmark, 26 March 2021 – Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has recommended that the use of Saxenda® is expanded for the treatment of obesity in adolescents aged 12–17 years.1
If approved, Saxenda® will be the first EU-approved treatment for obesity in adolescents. Saxenda® would be approved for the treatment of adolescents with obesity, with an initial body mass index (BMI) corresponding to ≥30 kg/m2 for adults and a body weight above 60 kg, in combination with healthy eating and increased physical activity.1 Saxenda® is already indicated for weight management in adults with a BMI ≥30 kg/m2, or ≥27 kg/m2 with one or more weight‑related comorbidity, as an adjunct to a reduced-calorie diet and increased physical activity.6
About the phase 3 trial (NCT02918279)
The trial investigated the safety and efficacy of Saxenda® (liraglutide 3.0 mg or maximum tolerated dose) compared to placebo for weight management in 251 adolescents (aged 12–17 years) living with obesity as an adjunct to lifestyle therapy. The trial included a 12-week run-in period of lifestyle therapy, a 56-week treatment period (including dose escalation over 4 to 8 weeks) on Saxenda® or placebo and a 26-week follow-up period without Saxenda® or placebo. All participants received lifestyle therapy beginning with the run-in period and during the 56-week treatment period and 26-week follow-up period.7 The evaluation of Saxenda® in the paediatric population was part of the Paediatric Investigation Plan (PIP) for Saxenda®, submitted and agreed upon with the EMA Paediatric Committee (PDCO).8,9
About Saxenda®
Saxenda® (liraglutide 3.0 mg) is a once-daily glucagon-like peptide-1 (GLP-1) analogue with 97% similarity to naturally occurring human GLP-1,6,10 a hormone that is released in response to food intake.11 Like human GLP-1, Saxenda® is believed to work in areas of the brain involved in appetite regulation, including the hypothalamus.12 Saxenda® for use in adults with obesity was evaluated in the SCALE (Satiety and Clinical Adiposity – Liraglutide Evidence) clinical trial programme. Since launch in 2015, more than 1.5 million patients have been treated with Saxenda® globally.13
Novo Nordisk wins EU recommendation for Saxenda label update
Mar. 26, 2021 4:07 PM ET Novo Nordisk A/S (NVO) By: Dulan Lokuwithana, SA News Editor2 Comments
- Novo Nordisk (NYSE:NVO) announced that the European Medicines Agency (“EMA”) has recommended the use of Saxenda in the treatment of obesity in adolescents aged 12–17 years.
- https://seekingalpha.com/news/3676952-novo-nordisk-wins-eu-recommendation-for-saxenda-label-update
- https://seekingalpha.com/symbol/NVO
Kesimpta® (ofatumumab)
Genmab Announces European Marketing Authorization for Kesimpta® (ofatumumab) in Relapsing Multiple Sclerosis
Mar 30, 2021 at 7:22 AM CEST
Company Announcement
- Novartis receives European approval for Kesimpta® (ofatumumab) for the treatment of relapsing forms of multiple sclerosis in adults
- Approval follows positive opinion by European Committee for Medicinal Products for Human Use (CHMP) in January 2021
- Approval based on Phase 3 ASCLEPIOS I and II studies
- First and only self-administered, targeted B-cell therapy for adult patients with relapsing multiple sclerosis approved in Europe
Copenhagen, Denmark; March 30, 2021 – Genmab A/S (Nasdaq: GMAB) announced today that the European Commission (EC) has granted Novartis marketing authorization for the use of Kesimpta® (ofatumumab) in the treatment of relapsing forms of multiple sclerosis (RMS) in adults with active disease defined by clinical or imaging features. The EC approval follows a positive opinion issued for subcutaneous ofatumumab in RMS by the CHMP of the European Medicines Agency (EMA) in January 2021. Kesimpta, which is developed and marketed worldwide by Novartis under a license agreement between Genmab and Novartis Pharma AG, is the first B-cell therapy that can be self-administered once-monthly at home via the Sensoready® autoinjector pen.
Kesimpta® (ofatumumab)
About ASCLEPIOS
The ASCLEPIOS I and II studies (NCT02792218 and NCT02792231) are twin, identical design, flexible duration (up to 30 months), double-blind, randomized, multi-center Phase 3 studies evaluating the safety and efficacy of ofatumumab 20mg monthly subcutaneous injections versus teriflunomide 14mg oral tablets taken once daily in adults with a confirmed diagnosis of RMS1,2. The studies enrolled 1,882 patients with RMS, between the ages of 18 and 55 years, with an Expanded Disability Status Scale (EDSS) score between 0 and 5.51,2. The studies were conducted in over 350 sites in 37 countries.
The primary endpoint of both studies was to demonstrate that ofatumumab is superior to teriflunomide in reducing the frequency of confirmed relapses as evaluated by the annualized relapse rate (ARR) in patients treated up to 30 months1,2. Secondary endpoints included time to disability progression confirmed at three and six months respectively, confirmed disability improvement at six months, gadolinium enhancing T1 lesions, number of new or enlarging T2 lesions, serum levels of neurofilament light chain (NfL), and rate of brain volume loss1,2. Safety and the pharmacokinetic properties of ofatumumab were also all measured throughout the treatment period1,2.
About Kesimpta® (ofatumumab)
Ofatumumab is a fully human CD20 monoclonal antibody. It is self-administered by a once-monthly injection, delivered subcutaneously. Initial doses of Kesimpta are given at Weeks 0, 1 and 2, with the first injection performed under the guidance of a healthcare provider. It is approved in the U.S. for the treatment of RMS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. In Europe Kesimpta is approved for the treatment of RMS in adults with active disease defined by clinical or imaging features. Kesimpta is the first B-cell therapy that can be self-administered at home by patients using a Sensoready® pen. Ofatumumab works by binding to the CD20 molecule on the B-cell surface and inducing potent B-cell lysis and depletion3. Ofatumumab is being developed and marketed worldwide by Novartis under a license agreement between Genmab and Novartis Pharma AG.
Indication
What is KESIMPTA (ofatumumab) injection?
KESIMPTA is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS) including clinically isolated syndrome (CIS), relapsing-remitting disease, and active secondary progressive disease.
It is not known if KESIMPTA is safe or effective in children.
Please see full Prescribing Information including Medication Guide.
For more information, please visit Genmab.com. https://www.genmab.com/
Genmab's Kesimpta OK'd in Europe for multiple sclerosis
Mar. 30, 2021 1:37 AM ET Genmab A/S (GMAB) By: Mamta Mayani, SA News Editor
- Genmab (NASDAQ:GMAB) announces that the European Commission (EC) has granted Novartis (NYSE:NVS) marketing authorization for the use of Kesimpta (ofatumumab) in the treatment of relapsing forms of multiple sclerosis (RMS) in adults.
- https://seekingalpha.com/news/3677432-genmabs-kesimpta-okd-in-europe-for-multiple-sclerosis
- https://seekingalpha.com/symbol/GMAB
- https://seekingalpha.com/symbol/NVS
Pemazyre® (pemigatinib)
Incyte Announces the European Commission Approval of Pemazyre® (pemigatinib) as a Treatment for Adults with Locally Advanced or Metastatic Cholangiocarcinoma with a Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion or Rearrangement
March 29, 2021 DownloadPDF Format (opens in new window)
- Pemazyre is the first targeted therapy approved in the EU for this indication
WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (Nasdaq:INCY) today announced that the European Commission (EC) has approved Pemazyre® (pemigatinib) for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. The decision follows the positive opinion received from the European Medicines Agency’s Committee for Medicinal Products for Human Use in January 2021 recommending the conditional marketing authorization of Pemazyre.
“Pemazyre’s approval is a crucial milestone for patients with FGFR2 positive cholangiocarcinoma. It is the first new treatment option to be made available to these patients in the EU in over a decade and has demonstrated a high rate of durable responses in a setting where historically there has been no effective standard of care,” said Hervé Hoppenot, Chief Executive Officer, Incyte. “We now look forward to working with individual countries in Europe to ensure eligible patients can access this new treatment as soon as possible.”
The EC decision is based on data from the FIGHT-202 study evaluating the safety and efficacy of Pemazyre in adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status. Interim results from FIGHT-202 demonstrated that in patients harboring FGFR2 fusions or rearrangements (Cohort A [108 patients]), Pemazyre monotherapy resulted in an overall response rate (ORR) of 37 percent (primary endpoint) and a median duration of response (DOR) of 8 months (secondary endpoint) based on an independent central radiographic review. Pemazyre was generally well tolerated. Warnings and precautions for Pemazyre include high and low levels of phosphate in the blood, vision or eye problems, blood creatinine increase and for women who are pregnant, a risk of harm to the fetus.
For more information about FIGHT-202, visit https://clinicaltrials.gov/ct2/show/NCT02924376.
Pemazyre® (pemigatinib)
About Pemazyre® (pemigatinib)
Pemazyre is a kinase inhibitor indicated in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test8. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, worsening after cancer chemotherapy.
In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations.
Pemazyre is marketed by Incyte in the United States, Europe and Japan. Incyte has granted Innovent Biologics, Inc. rights to develop and commercialize pemigatinib in hematology and oncology in Mainland China, Hong Kong, Macau and Taiwan. Incyte has retained all other rights to develop and commercialize pemigatinib outside of the United States.
Pemazyre is a trademark of Incyte Corporation.
For additional information on Incyte, please visit Incyte.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20210329005598/en/
Incyte's Pemazyre wins European Commission approval to treat rare form of cancer
Mar. 29, 2021 12:19 PM ET
Incyte Corporation (INCY) By: Aakash Babu, SA News Editor
- Incyte (INCY -0.8%) announces that the European Commission (EC) has approved Pemazyre (pemigatinib) for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
- https://seekingalpha.com/news/3677260-incytes-pemazyre-wins-european-commission-approval-to-treat-rare-form-of-cancer
- https://seekingalpha.com/symbol/INCY
- https://www.pemazyre.com/
March 30, 2021
U.S. FDA Accepts AbbVie's New Drug Application for Atogepant for the Preventive Treatment of Migraine
- If approved, atogepant will be the first and only oral CGRP receptor antagonist specifically developed for the preventive treatment of migraine[1]
- In the Phase 3 ADVANCE trial for the preventive treatment of migraine in adults with 4-14 migraine days, all active treatment arms of atogepant met their primary endpoint, and the 30 and 60 mg doses met all six secondary endpoints with statistical significance[1]
- Migraine is a debilitating neurological disease affecting 39 million people in the U.S.[2]
- The atogepant application demonstrates AbbVie's longstanding commitment to providing multiple migraine treatment options, including BOTOX® (onabotulinumtoxinA), a preventive treatment for those with chronic migraine, and UBRELVY® (ubrogepant), an acute treatment for adults with migraine
NORTH CHICAGO, Ill., March 30, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for atogepant, an investigational orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant), for the preventive treatment of migraine in adults who meet criteria for episodic migraine. AbbVie anticipates a regulatory decision in late Q3 2021.
Migraine is a complex, chronic disease with attacks that are often incapacitating and can include headache pain as well as neurologic and autonomic symptoms.3 Migraine symptoms and severity range widely among individuals.
About the Phase 3 ADVANCE Study
The pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial was designed to evaluate the efficacy, safety, and tolerability of oral atogepant for the preventive treatment of migraine in those with 4 to 14 migraine days per month. A total of 910 patients were randomized to one of four treatment groups evaluating 10 mg, 30 mg, and 60 mg of atogepant once daily, or placebo. Efficacy analyses were based on the modified intent-to-treat (mITT) population of 873 patients.
The primary endpoint was change from baseline in mean monthly migraine days across the 12-week treatment period. All atogepant dose groups met the primary endpoint and demonstrated statistically significant reductions in mean monthly migraine days compared to placebo. Patients treated in the 10 mg, 30 mg, and 60 mg atogepant arms experienced a decrease of 3.69, 3.86, and 4.2 days, respectively, compared to patients in the placebo arm, who experienced a decrease of 2.48 days (all dose groups vs. placebo, p=<.0001).
A key secondary endpoint measured the proportion of patients that achieved at least a 50% reduction in mean monthly migraine days across the 12-week treatment period. The trial demonstrated that 55.6%, 58.7%, and 60.8% of patients in the 10 mg, 30 mg, and 60 mg atogepant arms, respectively, achieved at least a 50% reduction, compared to 29.0% of patients in the placebo arm (all dose groups vs. placebo, p=<.0001).
All doses were well tolerated. The most common adverse events reported with a frequency ≥ 5% in at least one atogepant treatment arm, and greater than placebo, were constipation (6.9-7.7% across all doses vs. 0.5% for placebo), nausea (4.4-6.1% across all doses vs. 1.8% for placebo), and upper respiratory tract infection (3.9-5.7% across all doses vs. 4.5% for placebo). The majority of cases of constipation, nausea and upper respiratory tract infection were mild or moderate in severity and did not lead to discontinuation.
The study results were announced in a July 2020 press release and presented at the 2020 Virtual Migraine Trust International Symposium.
About the Phase 2b/3 CGP-MD-01 Study
The pivotal Phase 2b/3 clinical trial evaluating the efficacy, safety and tolerability of orally administered atogepant demonstrated that all active treatment arms met the primary endpoint with a statistically significant reduction from baseline in mean monthly migraine days compared with placebo across the 12-week treatment period in those with 4 to 14 migraine days per month. The results were announced in a June 2018 press release and were also presented at the 2019 American Headache Society Annual Meeting.
About the Phase 3 Long-Term Safety Study
The Phase 3, multicenter, randomized, open-label study evaluated the long-term safety and tolerability of 60 mg oral atogepant administered daily over 52 weeks for the preventive treatment of migraine in adults with 4-14 migraine days per month. Further details on the study will be presented at the American Academy of Neurology 2021 Virtual Annual Meeting.
About Atogepant
Atogepant is an investigational orally administered, CGRP receptor antagonist (gepant) specifically developed for the preventive treatment of migraine. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology. Studies have shown that CGRP levels are elevated during migraine attacks and selective CGRP receptor antagonists confer clinical benefit in migraine.
For more information about AbbVie, please visit us at www.abbvie.com.
FDA accepts Abbvie's atogepant application for migraine
Mar. 30, 2021 8:46 AM ETAbbVie Inc. (ABBV)By: Mamta Mayani, SA News Editor6 Comments
- The FDA has accepted AbbVie's (NYSE:ABBV) New Drug Application (NDA) for atogepant, an investigational orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant), for the preventive treatment of migraine.
- https://seekingalpha.com/news/3677551-fda-accepts-abbvies-atogepant-application-for-migraine
- https://seekingalpha.com/symbol/ABBV
Lenzilumab
Humanigen Reports Positive Phase 3 Topline Results Demonstrating That Lenzilumab™ Improves Survival Without Need for Mechanical Ventilation in Hospitalized Patients With COVID-19
Mar 29, 2021 DownloadPDF Format (opens in new window)
- Lenzilumab improved the relative likelihood of survival without need for invasive mechanical ventilation (IMV) by 54%, achieving the primary endpoint of the Phase 3 study
- Clinical improvement was observed over and above other treatments, including steroids and/or remdesivir
BURLINGAME, Calif.--(BUSINESS WIRE)-- Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, today announced positive topline results from its Phase 3 clinical trial evaluating the efficacy and safety of lenzilumab in patients hospitalized with COVID-19. Trial results showed that patients who received lenzilumab and other treatments, including steroids and/or remdesivir, had a 54% greater relative likelihood of survival without the need for IMV compared with patients receiving placebo and other treatments. These results are statistically significant.
“The results from our Phase 3 clinical trial with lenzilumab treatment were associated with better outcomes in hospitalized hypoxic COVID-19 patients who had not yet progressed to the point of requiring IMV,” said Cameron Durrant, MD, MBA, Chief Executive Officer, Humanigen. “Additionally, the trial incorporated a diverse population with various comorbidities, most commonly a body mass index above 30, which is representative of a real-world, high-risk population. Our next step is to submit an application for Emergency Use Authorization (EUA) to the Food and Drug Administration (FDA) as soon as possible. We are also sharing these results with US governmental agencies and other authorities worldwide.”
About the Lenzilumab Phase 3 Study
This study was a randomized, double-blind, placebo-controlled, multi-center Phase 3 trial for the treatment and prevention of serious and potentially fatal outcomes in patients who were hospitalized with COVID-19 pneumonia. The primary objective was to assess whether lenzilumab, in addition to other treatments, which included dexamethasone (or other steroids) and/or remdesivir, could alleviate the immune-mediated cytokine release syndrome (CRS) and improve ventilator-free survival. Ventilator-free survival is a composite endpoint of time to death and time to IMV, which is a robust measure that is less prone to favor a treatment with discordant effects on survival or days free of ventilation.1 The trial enrolled 520 patients in 29 sites in the US and Brazil who were at least 18 years of age; experienced blood oxygen saturation (SpO2) of less than or equal to 94%; or required low-flow supplemental oxygen, or high-flow oxygen support, or non-invasive positive pressure ventilation (NIPPV); and were hospitalized but did not require IMV. Following enrollment, subjects were randomized to receive three infusions of either lenzilumab or placebo, each infusion separated by eight hours over a 24-hour period with other treatments. The primary endpoint was the difference between lenzilumab treatment and placebo treatment in ventilator-free survival through 28 days following treatment. Key secondary endpoints, also measured through 28 days, included ventilator-free days, duration of ICU stay, incidence of invasive mechanical ventilation, extracorporeal membrane oxygenation (ECMO), and/or death, time to death, all-cause mortality, and time to recovery. Results of the trial are planned to be submitted for potential publication in a peer-reviewed journal.
For more information, visit www.humanigen.com
https://www.humanigen.com/pipeline
Humanigen surges on positive Phase 3 data for COVID-19 therapy
Mar. 29, 2021 7:40 AM ET
Humanigen, Inc. (HGEN) By: Dulan Lokuwithana, SA News Editor9 Comments
- Humanigen (NASDAQ:HGEN) has added ~43.8% in the pre-market after announcing that its lead drug candidate against COVID-19, lenzilumab achieved the primary endpoint in a Phase 3 study in patients who were hospitalized with COVID-19 pneumonia.
- https://seekingalpha.com/news/3677084-humanigan-surges-on-positive-phase-3-data-for-covid-19-therapy
- https://seekingalpha.com/symbol/HGEN
VASCEPA®/VAZKEPA
AMARIN RECEIVES EUROPEAN COMMISSION (EC) APPROVAL FOR VAZKEPA TO REDUCE CARDIOVASCULAR RISK
BackPDF VersionMar 30, 2021
Marks first and only EC-approved treatment to reduce cardiovascular risk in high-risk, statin-treated adult patients who have elevated triglycerides (≥150 mg/dL) and other risk characteristics as studied in REDUCE-IT® 1, 2
DUBLIN, Ireland and BRIDGEWATER, N.J., March 30, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ: AMRN) today announced that following a review and approval recommendation by the European Medicines Agency (EMA), the European Commission (EC) has approved the marketing authorization application for VAZKEPA (icosapent ethyl) to reduce the risk of cardiovascular events in high-risk, statin-treated adult patients who have elevated triglycerides (≥150 mg/dL) and either established cardiovascular disease or diabetes and at least one additional cardiovascular risk factor.
Amarin’s icosapent ethyl was approved for cardiovascular risk reduction by the U.S. Food and Drug Administration (FDA) in December 2019 and is marketed in the U.S. under the brand name, VASCEPA®.
“The approval of VAZKEPA marks a significant milestone for high-risk cardiovascular patients in Europe as it offers the first and only EC-approved therapy to reduce cardiovascular risk in high-risk statin-treated patients who have elevated triglycerides,” said Steven Ketchum, senior vice president, president of R&D and chief scientific officer of Amarin. “We look forward to launching VAZKEPA in Europe as it is an exciting opportunity for Amarin to make a difference in the lives of the many millions of patients throughout Europe who are at risk of a cardiovascular event.”
The EC approval for VAZKEPA is based on over a decade of development and testing of icosapent ethyl, including efficacy and safety data from the REDUCE-IT® cardiovascular outcomes study.2 REDUCE-IT evaluated more than 8,000 high risk patients who despite having their cholesterol levels well controlled by statin therapy remained at significant risk of heart attack, stroke, or other major adverse cardiovascular events (MACE), including death. As published, patients in the REDUCE-IT study had a median follow-up period of nearly five years. Results from this study, in which all patients remained treated with statins (and with other contemporary therapies) and where half the patients received icosapent ethyl and the other half received placebo, demonstrated a 25% relative risk reduction (p<0.001) in the first occurrence of MACE in the intent-to-treat patient population with use of icosapent ethyl (4 grams daily) compared with placebo.
VASCEPA®/VAZKEPA
About REDUCE-IT®
REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the effect of VASCEPA in adult patients with LDL-C controlled to between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort).
REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology.5 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.2 The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.6 These and other publications can be found in the R&D section on the company’s website at www.amarincorp.com.
About VASCEPA® (icosapent ethyl) Capsules
VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first and only drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk after statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed over ten million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, Lebanon and the United Arab Emirates. In Europe, marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA.
Indications and Limitation of Use (in the United States)
VASCEPA is indicated:
- As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and
- established cardiovascular disease or
- diabetes mellitus and two or more additional risk factors for cardiovascular disease.
- As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.
The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
VASCEPA and VAZKEPA are trademarks of Amarin Pharmaceuticals Ireland Limited. VAZKEPA is a registered trademark in Europe and other countries and regions and is pending registration in the United States.
Amarin wins EU approval for icosapent ethyl to treat cardiovascular patients
Mar. 30, 2021 7:42 AM ET
By: Dulan Lokuwithana, SA News Editor5 Comments
- Amarin Corporation (NASDAQ:AMRN) has added ~4.9% in the pre-market after announcing that the European Commission has approved its marketing application for Vazkepa (icosapent ethyl) to treat high-risk cardiovascular patients.
- https://seekingalpha.com/news/3677505-amarin-wins-eu-nod-for-icosapent-ethyl-to-treat-cardiovascular-patients
- https://seekingalpha.com/symbol/AMRN
- https://www.vascepa.com/
- https://amarincorp.com/default.aspx
Leronlimab (PRO 140)
CytoDyn’s Leronlimab Decreased Mortality at 14 Days by 82% With Statistically Significant P-Value of 0.0233 Amongst Critically Ill COVID-19 Patients
March 30, 2021 6:00am EDT
Clinical outcome improvement (based on ordinal scale) with leronlimab at day 14 was 400% better than placebo arm with p-value of 0.021
VANCOUVER, Washington, March 30, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), ("CytoDyn" or the "Company"), a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, is pleased to announce further results from its CD12 trial of severe-to-critically ill patients with COVID-19.
Upon further statistical analysis of the critically ill population (hospitalized patients receiving invasive mechanical ventilation (IMV) or ECMO), it was revealed that when leronlimab was added to standard of care (“SoC”), leronlimab decreased mortality at 14 days by 82% (p=.0233, N=62). Patients who received leronlimab were over five times more likely to be alive at day 14 than those who received SoC only.
Furthermore, leronlimab administration was associated with a 400% improvement in the ranking on the 7-point ordinal scale at 14 days when given in conjunction with SoC (p=.021, N=62) in the critically ill population, which provides direct evidence of tangible patient improvement.
This analysis builds upon the previously released information from the Company’s mITT analysis of CD12 showing:
- A clear benefit when leronlimab was used in addition to “commonly used COVID-19 treatments,” in the primary endpoint of all-cause mortality at day 28 with an absolute risk reduction of death of 6.5% and a relative risk reduction of death of 28.1% (N=309, p=.0319).
- A clear benefit when leronlimab was used in combination with dexamethasone, in the primary endpoint of all-cause mortality at day 28 with an absolute risk reduction of death of 5.7% and a relative risk reduction of 26.0% (N=233, p=.0552).
- Length in hospital stay decreased by 5.5 days in the critically ill population (N=62, p=.005).
- A clear trend toward mortality benefit at day 28 with an absolute risk reduction of death of 20.9% and a relative risk reduction of death of 73% when leronlimab was used in addition to “commonly used COVID-19 treatments” in the critically ill population with an age ≤ 65 years old.
- A clear trend toward mortality benefit at day 28 with an absolute risk reduction of death of 16.3% and a relative risk reduction of death of 73.5% when leronlimab was used in addition to dexamethasone in the critically ill population ≤ 65 years old.
Leronlimab (PRO 140)
About Leronlimab (PRO 140)
The FDA has granted a FastTrack designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first indication is combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed 11 clinical trials in over 1,200 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab combined with standard antiretroviral therapies in HIV-infected treatment-experienced patients).
In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.
Research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control in the setting of cancer. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation by the FDA in May 2019.
More information is at www.cytodyn.com.
CytoDyn’s leronlimab reduces mortality by 82% at 14 days in critically ill COVID-19 patients
Mar. 30, 2021 7:08 AM ETCytoDyn Inc. (CYDY)By: Mamta Mayani, SA News Editor8 Comments
- CytoDyn (OTCQB:CYDY) announces further results from its CD12 trial of severe-to-critically ill COVID-19 patients.
- https://seekingalpha.com/news/3677479-cytodyns-cydy-leronlimab-reduces-mortality-by-82-in-critical-covid-19-patients
- https://seekingalpha.com/symbol/CYDY
Drug Database: Leronlimab
https://clinicalinfo.hiv.gov/en/drugs/leronlimab/patient
Apr 01, 2021 6:00am EDT
CytoDyn files new protocol with FDA for 4 doses of leronlimab for critical COVID-19
Apr. 01, 2021 6:13 AM ETCytoDyn Inc. (CYDY)By: Mamta Mayani, SA News Editor23 Comments
- After several weeks of discussions with the FDA and analysis of CD12 trial data, CytoDyn (OTCQB:CYDY) has filed a new protocol for leronlimab to extend treatment to four weeks.
- https://seekingalpha.com/news/3678429-cytodyn-files-new-protocol-with-fda-for-4-doses-of-leronlimab-for-critical-covid-19
- https://seekingalpha.com/symbol/CYDY
Bamlanivimab with VIR-7831
Lilly, Vir Biotechnology and GSK Announce Positive Topline Data from the Phase 2 BLAZE-4 Trial Evaluating Bamlanivimab with VIR-7831 in Low-Risk Adults with COVID-19
03/29/21 at 8:30 AM EDTPDF Version– In combination, the two monoclonal antibodies demonstrated a 70% relative reduction in persistently high viral load at day 7 compared to placebo –
INDIANAPOLIS and SAN FRANCISCO and LONDON, March 29, 2021 (GLOBE NEWSWIRE) -- Eli Lilly and Company (NYSE: LLY), Vir Biotechnology, Inc. (NASDAQ: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) today announced topline data from the expanded Phase 2 BLAZE-4 trial studying low-risk adult patients with mild to moderate COVID-19. Results showed that investigational bamlanivimab (LY-CoV555) 700 mg co-administered with VIR-7831 (also known as GSK4182136) 500 mg demonstrated a 70 percent (p<0.001) relative reduction in persistently high viral load (> 5.27; cycle threshold value < 27.5) at day 7 compared to placebo, meeting the primary endpoint.
In addition, bamlanivimab administered with VIR-7831 demonstrated a statistically significant reduction compared to placebo in the key virologic secondary endpoints of mean change from baseline to days 3, 5 and 7 in SARS-CoV-2 viral load. There were no events for the secondary endpoint of COVID-19 related hospitalization or death by day 29 in either study arm. One patient (in the treatment arm) visited the emergency room for COVID-19 related symptoms. No serious adverse events were seen with co-administration of bamlanivimab and VIR-7831.
Bamlanivimab and VIR-7831 bind to different regions of the spike protein of SARS-CoV-2. Preclinical data suggest the administration of these two investigational antibodies together may provide protection against current variants of SARS-CoV-2 that are resistant to bamlanivimab.
Bamlanivimab with VIR-7831
Important Information about bamlanivimab
Bamlanivimab has not been approved by the FDA for any use. It is not known if bamlanivimab is safe and effective for the treatment of COVID-19.
Bamlanivimab is authorized under an Emergency Use Authorization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bamlanivimab under Section 564(b)(1) of the Act, 21 U.S.C § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Healthcare providers should review the Fact Sheet for information on the authorized use of bamlanivimab and mandatory requirements of the EUA. Please see the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents, and Caregivers (English) (Spanish).
Authorized Use and Important Safety Information
Bamlanivimab 700 mg injection is authorized for use under EUA for treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
About BLAZE-4
BLAZE-4 (NCT04634409) is a randomized, double-blind, placebo-controlled trial designed to assess the efficacy and safety of bamlanivimab alone, and bamlanivimab with other neutralizing antibodies including VIR-7831 (GSK4182136) versus placebo for the treatment of symptomatic low-risk COVID-19 in the outpatient setting. Across all treatment arms, the trial will enroll an estimated 1,000 participants in the United States and Puerto Rico.
The primary outcome measure is percentage of participants who have a viral load greater than 5.27 at day 7. Additional endpoints include viral load change from baseline to day 7 in SARS-CoV-2 viral load, percentage of participants who experience COVID-related hospitalization, ER visit or death from baseline through day 29, as well as safety.
About COMET-ICE
COMET-ICE is a multi-center, double-blind, placebo-controlled Phase 3 trial evaluating VIR-7831 in adults with mild or moderate COVID-19 at high risk of progression to severe disease. The trial was stopped for enrollment on March 10, 2021, based on an interim analysis, which demonstrated an 85% (p=0.002) reduction in hospitalization or death in those receiving VIR-7831 compared to placebo.
About bamlanivimab
Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.
Lilly has successfully completed a Phase 1 study of bamlanivimab in hospitalized patients with COVID-19 (NCT04411628). A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is ongoing. In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study in ambulatory COVID-19 patients.
Bamlanivimab is authorized in the U.S. for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.
About VIR-7831 / GSK4182136
VIR-7831 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831, which incorporates Xencor’s Xtend™ technology, also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.
About the Vir and GSK Coronavirus Collaboration
In April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration uses Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK’s expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.
About Lilly’s COVID-19 Efforts
Lilly is bringing the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world. Existing Lilly medicines are being studied to understand their potential in treating complications of COVID-19, and the company is collaborating with partner companies to discover novel antibody treatments for COVID-19. Lilly is testing both single antibody therapy as well as combinations of antibodies as potential therapeutics for COVID-19. Visit Lilly’s COVID-19 disease area page for resources related to Lilly's COVID-19 efforts.
To learn more about Lilly, please visit us at www.lilly.com and www.lilly.com/news.
For more information, please visit www.vir.bio.
For further information please visit www.gsk.com/about-us.
Lilly, Vir Bio, GSK's cocktail antibody shows positive action in COVID-19
Mar. 29, 2021 8:50 AM ETEli Lilly and Company (LLY)By: Mamta Mayani, SA News Editor4 Comments
- Eli Lilly (NYSE:LLY), Vir Biotechnology (NASDAQ:VIR) and GlaxoSmithKline (NYSE:GSK) announce topline data from the expanded phase 2 BLAZE-4 trial studying low-risk adult patients with mild-to-moderate COVID-19.
- https://seekingalpha.com/news/3677146-lilly-vir-bio-gsks-cocktail-antibody-shows-positive-action-in-covid-19
- https://seekingalpha.com/symbol/LLY
- https://seekingalpha.com/symbol/GSK
- https://seekingalpha.com/symbol/VIR
biotecMAX™ January/ February/March 2021 Insight
XTANDI™ (enzalutamide)
Astellas Receives Positive CHMP Opinion for XTANDI™ (enzalutamide) for Patients with Metastatic Hormone-Sensitive Prostate CancerIf approved by the European Commission, enzalutamide will be the only oral therapy for the treatment of metastatic hormone-sensitive prostate cancer in addition to non-metastatic and metastatic castration-resistant prostate cancer
TOKYO, March 26, 2021 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced today the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending an additional indication for the oral once-daily therapy XTANDITM (enzalutamide) for adult men with metastatic hormone-sensitive prostate cancer (mHSPC, also known as metastatic castration-sensitive prostate cancer or mCSPC).1 Men diagnosed with mHSPC tend to have a poor prognosis, with a median survival of approximately 3-4 years, underscoring the need for new treatment options.2
If approved by the European Commission (EC), enzalutamide will be the only oral treatment approved by the EC to treat three distinct types of advanced prostate cancer — non-metastatic and metastatic castration-resistant prostate cancer (CRPC) and mHSPC.3 The CHMP decision is based on data from the pivotal Phase 3 ARCHES trial investigating enzalutamide in men with mHSPC.4
Data from the ARCHES trial showed that enzalutamide plus androgen deprivation therapy (ADT) significantly reduced the risk of radiographic progression or death by 61% versus placebo plus ADT in men with mHSPC (n=1,150; hazard ratio [HR]=0.39 [95% confidence interval (CI): 0.30-0.50]; P<0.0001).4
XTANDI™ (enzalutamide)
About XTANDI™ (enzalutamide)
Enzalutamide is currently indicated in the EU for:3
- the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC);
- the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated; and
- the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.
For more information, please visit our website at https://www.astellas.com/en.
About the Pfizer/Astellas Collaboration
In October 2009, Medivation, Inc, which is now part of Pfizer (NYSE:PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize enzalutamide. The companies jointly commercialize enzalutamide in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing enzalutamide outside the United States.
Astellas Press Release. XTANDI® (enzalutamide) Approved by Japan MHLW for the Treatment of Prostate Cancer with Distant Metastasis. Available at: https://www.astellas.com/system/files/news/2020-05/20200529_en_1.pdf. Last accessed March 2021.
Astellas and Pfizer's XTANDI gets EMA positive opinion for additional indication
Mar. 26, 2021 8:53 AM ET Pfizer Inc. (PFE) By: Aakash Babu, SA News Editor
- The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on an additional indication for Astellas Pharma (OTCPK:ALPMY) and Pfizer's (NYSE:PFE) XTANDI treatment for adult men with metastatic hormone-sensitive prostate cancer.
- https://seekingalpha.com/news/3676755-astellas-and-pfizers-xtandi-gets-ema-positive-opinion-for-additional-indication
- https://seekingalpha.com/symbol/ALPMY
- https://seekingalpha.com/symbol/PFE
ABECMA (idecabtagene vicleucel)
U.S. Food and Drug Administration Approves Bristol Myers Squibb’s and bluebird bio’s Abecma (idecabtagene vicleucel), the First Anti-BCMA CAR T Cell Therapy for Relapsed or Refractory Multiple Myeloma
03/26/2021CATEGORY:
Abecma is a first-in-class BCMA-directed personalized immune cell therapy delivered as a one-time infusion for triple-class exposed patients with multiple myeloma1
In the pivotal KarMMa trial, the majority (72%) of patients achieved rapid, deep and durable responses1
Safety profile of Abecma is well-established and predictable including cytokine release syndrome and neurologic toxicities that are mostly low-grade with early onset and resolution1
PRINCETON, N.J., & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) has approved Abecma (idecabtagene vicleucel; ide-cel) as the first B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Abecma is a personalized immune cell therapy approved as a one-time infusion with a recommended dose range of 300 to 460 x 106 CAR-positive T cells.1 As an anti-BCMA CAR T cell therapy, Abecma recognizes and binds to BCMA, a protein that is nearly universally expressed on cancer cells in multiple myeloma, leading to the death of BCMA-expressing cells.2 Please see the Important Safety Information section below, including Boxed WARNINGS for Abecma regarding Cytokine Release Syndrome (CRS), Neurologic Toxicities (NT), Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), and Prolonged Cytopenia.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210326005507/en/
(Photo: Business Wire)
“CAR T cell therapies have shown transformational potential for the treatment of hematologic malignancies, and we, with our partners at bluebird bio, are proud to bring the first CAR T cell therapy to appropriate triple-class exposed patients with relapsed or refractory multiple myeloma, offering the chance for durable response,” said Samit Hirawat, M.D., chief medical officer, Bristol Myers Squibb. “Bristol Myers Squibb is now the only company with two approved CAR T cell therapies with distinct targets of CD19 and BCMA. As our second FDA-approved CAR T cell therapy, Abecma underscores our commitment to deliver on the promise of cell therapies for patients who are battling aggressive and advanced blood cancers with limited effective treatment options.”
ABECMA (idecabtagene vicleucel)
Indication
ABECMA (idecabtagene vicleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.
Learn more about the science behind cell therapy and ongoing research at Bristol Myers Squibb here.
For more information about Bristol Myers Squibb, visit us at BMS.com
For more information, visit bluebirdbio.com.
Bristol Myers and Bluebird bio win FDA approval for ide-cel in multiple myeloma
Mar. 26, 2021 11:40 PM ET Bristol-Myers Squibb Company (BMY)
By: Dulan Lokuwithana, SA News Editor21 Comments
- Bristol Myers Squibb (NYSE:BMY) and bluebird bio (NASDAQ:BLUE) announced the FDA approval for idecabtagene vicleucel (ide-cel) for a certain category of adult patients with relapsed or refractory multiple myeloma. The FDA authorization has come a day ahead of the action date.
- https://seekingalpha.com/news/3677011-bristol-myers-and-bluebird-bio-wins-fda-approval-for-ide-cel-in-multiple-myeloma
- https://seekingalpha.com/symbol/BLUE
- https://seekingalpha.com/symbol/BMY
VIR-7831
GSK and Vir Biotechnology Announce Submission of Emergency Use Authorization Request to FDA for VIR-7831 for the Early Treatment of COVID-19
03/26/21 at 8:30 AM EDTPDF Version
LONDON and SAN FRANCISCO, March 26, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced the submission of an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for VIR-7831 (GSK4182136), an investigational dual-action SARS-CoV-2 monoclonal antibody for the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with mild-to-moderate COVID-19 who are at risk for progression to hospitalization or death.
The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization. Results of the interim analysis, based on data from 583 patients enrolled in the trial, demonstrated an 85% (p=0.002) reduction in hospitalization or death in those receiving VIR-7831 compared to placebo, the primary endpoint of the trial. As a result, the Independent Data Monitoring Committee recommended that the trial be stopped for enrollment due to evidence of profound efficacy. Data from the registrational COMET-ICE trial also will form the basis for a Biologics License Application (BLA) submission to the FDA.
VIR-7831
About the VIR-7831 Clinical Development Program
In addition to the COMET-ICE trial, the full COMET clinical development program for VIR-7831 includes:
- COMET-PEAK: An ongoing Phase 2 trial with two parts: to compare the safety and viral kinetics of 500 mg intramuscularly (IM) administered VIR-7831 to 500 mg intravenously administered VIR-7831 among low-risk adults with mild to moderate COVID-19 and to evaluate the similarity in pharmacokinetics between VIR-7831 manufactured by different processes.
- COMET-TAIL: A Phase 3 trial expected to begin in the second quarter of 2021 in high-risk adults to assess whether IM-administered VIR-7831 can reduce hospitalization or death due to COVID-19.
- COMET-STAR: A Phase 3 trial expected to begin in the second quarter of 2021 in uninfected adults at high risk to determine whether IM-administered VIR-7831 can prevent symptomatic infection.
VIR-7831 is also being evaluated in the outpatient setting in BLAZE-4, a Phase 2 trial sponsored by Eli Lilly and Company, designed to assess the safety and efficacy of Eli Lilly’s bamlanivimab (LY-CoV555) alone and bamlanivimab with other neutralizing antibodies, including VIR-7831, versus placebo in low-risk adults with mild to moderate COVID-19. Additionally, VIR-7831, along with VIR-7832 will be evaluated in the Phase 1b/2a National Health Service-supported AGILE trial in adults with mild to moderate COVID-19. VIR-7832 is the second monoclonal antibody from the Vir-GSK collaboration to be investigated as a potential COVID-19 treatment.
VIR-7831 and VIR-7832 are investigational compounds, not approved by the U.S. Food and Drug Administration or any other regulatory authority.
About VIR-7831 / GSK4182136
VIR-7831 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831, which incorporates Xencor’s Xtend™ technology, also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.
About VIR-7832 / GSK4182137
VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7832, which incorporates Xencor’s Xtend and other Fc technologies, has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.
About the Vir and GSK Collaboration
In April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration uses Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK’s expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.
For further information please visit www.gsk.com/about-us.
For more information, please visit www.vir.bio.
GlaxoSmithKline and Vir Biotech seek FDA authorization for COVID-19 therapy
Mar. 26, 2021 8:47 AM ET GlaxoSmithKline plc (GSK) By: Dulan Lokuwithana, SA News Editor2 Comments
- GlaxoSmithKline (NYSE:GSK) and Vir Biotechnology (NASDAQ:VIR) announced the submission of an application to the FDA requesting the Emergency Use Authorization (“EUA”) for VIR-7831, a SARS-CoV-2 monoclonal antibody.
- https://seekingalpha.com/news/3676752-glaxosmithkline-and-vir-biotech-seek-fda-approval-for-covid-19-therapy
- https://seekingalpha.com/symbol/GSK
- https://seekingalpha.com/symbol/VIR
IBRANCE® (PALBOCICLIB)
REAL-WORLD EVIDENCE SUPPORTS EFFECTIVENESS OF FIRST-LINE IBRANCE® (PALBOCICLIB) COMBINATION THERAPY IN HR+, HER2- METASTATIC BREAST CANCER
Thursday, March 25, 2021 - 06:45am
First large-scale comparative effectiveness analysis of a CDK 4/6 inhibitor plus letrozole evaluating progression-free and overall survival versus letrozole alone
NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE:PFE) today announced the peer-reviewed publication of real-world evidence (RWE) demonstrating that first-line therapy with IBRANCE® (palbociclib) in combination with letrozole was associated with improved real-world progression-free survival (rwPFS) and overall survival (OS) in women with hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2-) metastatic breast cancer (mBC) compared with letrozole alone. These findings represent the first comprehensive comparative effectiveness analysis of survival outcomes for a CDK 4/6 inhibitor in routine clinical practice and were published online in Breast Cancer Research.
At a median follow-up of approximately two years and after balancing for baseline demographic and clinical characteristics, median rwPFS was 20.0 months with IBRANCE plus letrozole versus 11.9 months with letrozole alone (HR 0.58: 95% CI, 0.49 to 0.69; p<0.0001) in this observational, retrospective real-world analysis. Median OS was not reached among patients in the IBRANCE group and was 43.1 months among patients in the letrozole group (HR 0.66: 95% CI, 0.53 to 0.82; P=0.0002). These findings represent a 42% reduction in the risk of progression and a 34% reduction in the risk of death.
IBRANCE® (PALBOCICLIB)
Real-world evidence is woven into the fabric of how we innovate and advance care for patients with breast cancer, supporting our randomized clinical trials,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “With more than six years of patient experience, a positive benefit-risk profile, strong clinical data and robust real-world data, the totality of evidence solidifies the role of IBRANCE plus endocrine therapy as a treatment for patients with HR+, HER2- metastatic breast cancer.”
The analysis also showed the two-year OS rate was 78.3% in the IBRANCE group and 68.0% with letrozole. The rwPFS and OS benefits were generally consistent across all subgroups, including younger patients (18-50 years of age) and site or extent of metastases.
“Real-world evidence is increasingly used to complement traditional randomized clinical trial data to better understand a therapy’s effectiveness in routine clinical practice and inform treatment decisions,” said Angela DeMichele, M.D., lead researcher and Professor in Breast Cancer Excellence in the Perelman School of Medicine at the University of Pennsylvania. “The findings from this landmark real-world study align with the positive impact that I have seen in my own patients treated with IBRANCE combination therapy.”
The data for this retrospective observational analysis was collected from the Flatiron Health de-identified longitudinal database, which includes patient records from Flatiron’s network of more than 280 community cancer clinics and partnerships with major academic cancer centers across the U.S. This real-world cohort includes more than 1,400 women with HR+, HER2- mBC with any extent of visceral disease. Safety data were not collected as part of this analysis.
The data from this real-world analysis is consistent with available data from the Phase 3 PALOMA-2 trial, which studied IBRANCE plus letrozole versus placebo plus letrozole as initial endocrine-based therapy in post-menopausal women with estrogen-receptor positive (ER+), HER2- mBC. However, this observational analysis differs from the randomized clinical trial in several ways. The studies have different endpoints and there are inherent limitations in real-world observational studies, including lack of randomization, lack of uniform timing or type of clinical assessments and challenges with missing data. OS data is being collected in the PALOMA-2 randomized clinical trial but is not yet mature.
About IBRANCE® (palbociclib) 125 mg tablets and capsules
IBRANCE is an oral inhibitor of CDKs 4 and 6,1 which are key regulators of the cell cycle that trigger cellular progression.2,3 In the U.S., IBRANCE is indicated for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or in men; or with fulvestrant in patients with disease progression following endocrine therapy.
The full U.S. Prescribing Information for the IBRANCE tablets and the IBRANCE capsules can be found here and here.
IMPORTANT IBRANCE®(palbociclib) SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION
to learn more, please visit us on www.Pfizer.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20210325005221/en/
https://seekingalpha.com/symbol/PFE
INDICATIONS
IBRANCE 125 mg capsules and tablets are a prescription medicine used in adults to treat hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that has spread to other parts of the body (metastatic) in combination with:
- an aromatase inhibitor as the first hormonal based therapy in postmenopausal women or in men, or
- fulvestrant in people with disease progression following hormonal therapy.
Please see Full Prescribing Information and Patient Information.
KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination With Ivacaftor
Vertex Receives CHMP Positive Opinion for KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination With Ivacaftor to Treat People With Cystic Fibrosis With At Least One F508del Mutation
- If approved, people ages 12 years and older who have one copy of the F508del mutation and a gating (F/G) or residual function (F/RF) mutation will now be eligible for triple combination therapy -
LONDON – [26 March 2021] – Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the label extension of KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in a combination with ivacaftor 150 mg tablets for the treatment of cystic fibrosis (CF) in all patients ages 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, the most common CF-causing mutation worldwide. If the European Commission follows the recommendation, the majority of people with CF in Europe will be eligible for the medicine.
KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination With Ivacaftor
In Europe, KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor is currently licensed for the treatment of people with CF ages 12 years and older with an F/F or F/MF genotype.
About KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in a Combination With Ivacaftor
KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with ivacaftor 150 mg was developed for the treatment of cystic fibrosis (CF) in patients ages 12 years and older with two F508del mutations (F/F) or one F508del mutation and one minimal function mutation (F/MF) in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor/tezacaftor/elexacaftor is designed to increase the quantity and function of the F508del-CFTR protein at the cell surface. The current approved EU licensed indication for ivacaftor/tezacaftor/elexacaftor was supported by positive results of two global Phase 3 studies in people ages 12 years and older with CF: a 24-week Phase 3 study in 403 people with one F508del mutation and one minimal function mutation (F/MF) and a four-week Phase 3 study in 107 people with two F508del mutations (F/F).
the company's website at www.vrtx.com
Vertex's KAFTRIO combo gets EMA positive opinion for label extension
Mar. 26, 2021 7:43 AM ET Vertex Pharmaceuticals Incorporated (VRTX) By: Aakash Babu, SA News Editor
- Vertex Pharmaceuticals (NASDAQ:VRTX) has received positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the label extension of KAFTRIO (ivacaftor/tezacaftor/elexacaftor) in a combination with ivacaftor 150 mg tablets for the treatment of cystic fibrosis.
- https://seekingalpha.com/news/3676712-vertexs-kaftrio-combo-gets-ema-positive-opinion-for-label-extension
- https://seekingalpha.com/symbol/VRTX
- https://www.vrtx.com/research-development/pipeline/
PONVORY™ (ponesimod)
Janssen Receives Positive CHMP Opinion for PONVORY™ (ponesimod) for the Treatment of Adults With Relapsing Forms of Multiple Sclerosis With Active Disease Defined by Clinical or Imaging FeaturesPositive opinion is based on the pivotal Phase 3 OPTIMUM study evaluating the efficacy and safety of ponesimod vs. teriflunomide, an active comparator and oral standard of care treatment in adult patients with relapsing multiple sclerosis[1]
The OPTIMUM study demonstrated a statistically significant reduction in relapses and number of inflammatory lesions compared with teriflunomide[2]
BEERSE, BELGIUM, MARCH 26, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for PONVORY™ (ponesimod) for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features.[3]
“Relapsing forms of multiple sclerosis (MS) have varied and often unpredictable symptoms, posing a unique human, societal and economic burden,” said Catherine Taylor, M.D., Vice President, Medical Affairs Therapeutic Area Strategy, Europe, Middle East and Africa (EMEA), Johnson & Johnson Middle East FZ-LLC. “Despite continuous innovations in the treatment landscape, unmet needs remain. If approved by the European Commission, ponesimod has the potential to help more people living with relapsing forms of MS.”
PONVORY™ (ponesimod)
About Ponesimod
Ponesimod is a highly selective S1P1 modulator that functionally inhibits S1P1 receptor activity and, in doing so, it is believed to reduce the number of circulating lymphocytes.[7] In patients with MS, inflammatory immune cells, including lymphocytes, can cross the blood brain barrier into the brain and damage myelin, the protective sheath that insulates nerve cells. Damage to myelin slows or halts nerve conduction, producing the neurologic signs and symptoms of MS.[8]
A member of the Janssen Pharmaceutical Companies of Johnson & Johnson, Actelion Pharmaceuticals Ltd, is party to a revenue sharing agreement with Idorsia Pharmaceuticals Ltd, which provides for certain payments to Idorsia related to the sales of ponesimod.
Adverse events should be reported. This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product. Adverse events should be reported to Janssen-Cilag Limited on 01494 567447 or at dsafety@its.jnj.com and to regulatory authorities.
Learn more at www.janssen.com/emea.
J&J's multiple sclerosis drug Ponvory receives positive CHMP opinion
Mar. 26, 2021 8:48 AM ET Johnson & Johnson (JNJ) By: Jonathan M Block, SA News Editor
- The European Medicine Agency's Committee for Medicinal Products for Human Use ("CHMP") has adopted a positive opinion for Johnson & Johnson's (NYSE:JNJ) Ponvory (ponesimod) as an oral treatment for relapsing multiple sclerosis.
- The FDA approved Ponvory earlier this month.
- https://seekingalpha.com/news/3676745-johnson-johnson-multiple-sclerosis-drug-ponvory-receives-positive-chmp-opinion
- https://seekingalpha.com/symbol/JNJ
- https://www.jnj.com/
The European Medicines Agency’s CHMP issues a positive opinion recommending marketing authorisation for Ponvory (ponesimod) to treat adults with relapsing forms of multiple sclerosis
March 26, 2021 08:28 ET | Source: Idorsia Pharmaceuticals Ltd
Allschwil, Switzerland – March 26, 2021
TRODELVY™ (sacituzumab govitecan-hziy)
March 25, 2021
European Medicines Agency Validates Marketing Authorization Application for Sacituzumab Govitecan-Hziy for the Treatment of Metastatic Triple-Negative Breast Cancer
– Agency Grants Accelerated Assessment Based on Positive Results of Phase 3 ASCENT Trial –
– Supplementary Biologics License Application Currently Under Review by the U.S. FDA for Full Marketing Approval –
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for sacituzumab govitecan-hziy (SG) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received at least two prior therapies, including at least one prior therapy for locally advanced or metastatic disease. The MAA is now under accelerated review by the EMA, in recognition of the product being considered of major interest for public health and therapeutic innovation.
SG is a first-in-class therapy targeting Trop-2, a protein frequently expressed in multiple types of epithelial tumors, such as TNBC, where high expression is associated with poor survival and relapse. Currently, in the European Union (EU), there is no authorized standard treatment regimen with proven benefit in overall survival (OS) for patients with previously treated metastatic TNBC.
SG (under the tradename Trodelvy®) received accelerated approval by the U.S. Food and Drug Administration (FDA) to treat adult patients with metastatic TNBC who have received at least two prior therapies for metastatic disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
About the ASCENT Study
The Phase 3 ASCENT study, an international, multi-center, randomized confirmatory trial, enrolled more than 500 patients with relapsed/refractory metastatic TNBC who had received at least two prior therapies for metastatic disease. Patients were randomized to receive either sacituzumab govitecan-hziy or a chemotherapy chosen by the patients’ treating physicians. The primary endpoint of the study was progression-free survival (PFS) in patients without brain metastasis at baseline. Secondary endpoints include PFS for the full study population, OS, objective response rate (ORR), duration of response (DoR), and time to response. More information about ASCENT is available at http://clinicaltrials.gov/show/NCT02574455.
About Sacituzumab Govitecan-Hziy
SG is an antibody and topoisomerase inhibitor conjugate directed to the Trop-2 cell surface antigen, a protein frequently expressed in multiple types of epithelial tumors, including TNBC, where high expression is associated with poor survival and relapse.
In addition to multiple ongoing studies of SG in triple-negative breast cancer, it is being developed as an investigational treatment for metastatic urothelial cancer, hormone receptor-positive/HER 2-negative metastatic breast cancer, and metastatic non-small cell lung cancer, either as a monotherapy or in combination with other agents.
For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210325005912/en/
EMA validates Gilead's breast cancer treatment marketing authorization application
Mar. 25, 2021 4:19 PM ET Gilead Sciences, Inc. (GILD) By: Aakash Babu, SA News Editor
- Gilead Sciences (NASDAQ:GILD) announces that the European Medicines Agency (EMA) has backed the Marketing Authorization Application (MAA) for sacituzumab govitecan-hziy (SG) for the treatment of certain adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC).
- https://seekingalpha.com/news/3676567-ema-validates-gileads-breast-cancer-treatment-marketing-authorization-application
- https://seekingalpha.com/symbol/GILD
WHAT IS TRODELVY?
TRODELVY™ (sacituzumab govitecan-hziy) is a prescription medicine used to treat adults with a certain type of breast cancer known as triple-negative (HR and HER2 negative) that has spread to other parts of the body (metastatic) and who received at least two therapies for metastatic disease.
TRODELVY is approved based on medical studies that measured how many patients responded and how long they responded. Continued approval may depend on benefit demonstrated in additional medical studies.
It is not known if TRODELVY is safe and effective in people with moderate or severe liver problems or in children.
PADCEV (enfortumab vedotin-ejfv)
European Medicines Agency Accepts Marketing Authorization Application for Enfortumab Vedotin
03/26/2021
- Enfortumab vedotin to be reviewed under accelerated assessment for the treatment of locally advanced or metastatic urothelial cancer -
TOKYO & BOTHELL, Wash.--(BUSINESS WIRE)--
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seagen Inc. (Nasdaq:SGEN) today announced that a marketing authorization application (MAA) for enfortumab vedotin was accepted by the European Medicines Agency (EMA). The MAA requests review of enfortumab vedotin for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and who have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. If approved, enfortumab vedotin would be the first antibody-drug conjugate (ADC) available in the European Union for people living with urothelial cancer.
Enfortumab vedotin will be reviewed under accelerated assessment, which means the EMA’s Committee for Medicinal Products for Human Use (CHMP) can reduce the timeframe for evaluation.
About the EV-301 Trial
The EV-301 trial (NCT03474107) is a global, multicenter, open-label, randomized phase 3 trial designed to evaluate enfortumab vedotin versus physician's choice of chemotherapy (docetaxel, paclitaxel or vinflunine) in approximately 600 patients with locally advanced or metastatic urothelial cancer who were previously treated with a PD-1/L1 inhibitor and platinum-based therapies. The primary endpoint is overall survival and secondary endpoints include progression-free survival, overall response rate, duration of response and disease control rate, as well as assessment of safety/tolerability and quality-of-life parameters.6
About Enfortumab Vedotin
Enfortumab vedotin is an antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.7,8 Nonclinical data suggest the anticancer activity of enfortumab vedotin is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).8
PADCEV (enfortumab vedotin-ejfv) U.S. Important Safety Information
PADCEV (enfortumab vedotin-ejfv)
WHAT IS PADCEV™?
PADCEV (enfortumab vedotin-ejfv) is a prescription medicine used to treat adults with bladder cancer and cancers of the urinary tract (renal pelvis, ureter or urethra) that has spread or cannot be removed by surgery. PADCEV may be used if you have received an immunotherapy medicine and also received a chemotherapy-containing platinum medicine. It is not known if PADCEV is safe and effective in children.
PADCEV was FDA-approved based on a clinical study that measured how many patients had a tumor response. There is another study with PADCEV to confirm the clinical benefit.
For more information, please see the full Prescribing Information for PADCEV here.
About the Astellas and Seagen Collaboration
Astellas and Seagen Inc. are co-developing enfortumab vedotin under a 50:50 worldwide development and commercialization collaboration. In the United States, Astellas and Seagen co-promote enfortumab vedotin under the brand name PADCEV® (enfortumab vedotin-ejfv). In the Americas outside the US, Seagen holds responsibility for commercialization activities and regulatory filings. Outside of the Americas, Astellas holds responsibility for commercialization activities and regulatory filings.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210325005903/en/
EMA accepts Astellas, Seagen's enfortumab vedotin application in urothelial cancer
Mar. 26, 2021 3:04 AM ET Astellas Pharma Inc. (ALPMF) By: Mamta Mayani, SA News Editor
- The EMA has accepted Astellas Pharma (OTCPK:ALPMF) and Seagen's (NASDAQ:SGEN) marketing authorization application (MAA) for enfortumab vedotin, for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy in the neoadjuvant/adjuvant setting.
- https://seekingalpha.com/news/3676653-ema-accepts-enfortumab-vedotin-application-in-urothelial-cancer
- https://seekingalpha.com/symbol/ALPMF
- https://seekingalpha.com/symbol/SGEN
R&D Pipeline The list shows the development status in the target diseases for which we aim to obtain approval in Japan, the United States, Europe and/or China. As of Jan 2021
Major Pipeline
https://www.astellas.com/en/science/pipeline
CINREBAFUSP ALFA (PRS-343) IN COMBINATION WITH TUKYSA® (TUCATINIB)
PIERIS ANNOUNCES AMENDMENT OF EXISTING IMMUNO-ONCOLOGY MULTI-TARGET COLLABORATION WITH SEAGEN, A CLINICAL TRIAL AND SUPPLY AGREEMENT TO EVALUATE CINREBAFUSP ALFA (PRS-343) IN COMBINATION WITH TUKYSA® (TUCATINIB) IN GASTRIC CANCER, AND STRATEGIC EQUITY INVESTMENT BY SEAGEN
- Seagen will supply Pieris with TUKYSA® to evaluate the drug in combination with cinrebafusp alfa (PRS-343) in gastric cancer
- Pieris' co-development option for one program from existing multi-target collaboration amended to US co-promotion option with increased royalties if exercised
- Seagen to purchase $13 million equity stake in Pieris common stock
BOSTON, MA / ACCESSWIRE / March 25, 2021 / Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for respiratory diseases, cancer, and other indications, today announced that Seagen has made a strategic equity investment in Pieris as part of an ongoing collaboration between the companies. In addition, the companies have entered into a clinical trial collaboration agreement to evaluate the safety and efficacy of combining Pieris' cinrebafusp alfa (PRS-343), a 4-1BB/HER2 bispecific, with Seagen's TUKYSA® (tucatinib), a small-molecule tyrosine kinase HER2 inhibitor, for the treatment of gastric cancer patients expressing lower HER2 levels (IHC2+/ISH- & IHC1+) as part of the upcoming phase 2 study to be conducted by Pieris. The companies have also amended their existing immuno-oncology collaboration agreement around joint development and commercial rights for the second of up to three products in the alliance.
The combination of cinrebafusp alfa and TUKYSA could potentially address a high medical need in HER2 low-expressing gastric cancer patients who do not respond to traditional HER2-targeted therapies. Preclinical studies show that TUKYSA synergizes with cinrebafusp alfa to enhance its 4-1BB-mediated immune cell stimulation. This effect was observed across a range of HER2 expressing cell lines (IHC3+, 2+, and 1+), including those where cinrebafusp alfa had limited single-agent activity.
"Preclinical data exploring the combination of cinrebafusp alfa and TUKYSA are encouraging and support evaluating the combination in the planned phase 2 clinical trial," said Marjorie Green, M.D., Senior Vice President, Late-Stage Development of Seagen. "We are pleased to supply drug for Pieris to explore the potential combination of these agents to address an important unmet medical need."
About Cinrebafusp Alfa
Cinrebafusp alfa (PRS-343) is a 4-1BB/HER2 fusion protein comprising a 4-1BB-targeting Anticalin protein and a HER2-targeting antibody. The drug candidate is currently in development for the treatment of HER2-positive solid tumors. Based on encouraging phase 1 study results, which demonstrated clinical benefit as single agent and biomarker data indicative of a 4-1BB-driven mechanism of action, the Company is actively working towards initiating a phase 2 study of cinrebafusp alfa in combination with ramucirumab and paclitaxel for the treatment of HER2-positive gastric cancer and, under the phase 2 protocol, in combination with tucatinib.
About Pieris Pharmaceuticals:
Pieris is a clinical-stage biotechnology company that discovers and develops Anticalin protein-based drugs to target validated disease pathways in a unique and transformative way. Our pipeline includes inhalable Anticalin proteins to treat respiratory diseases and immuno-oncology multi-specifics tailored for the tumor microenvironment. Proprietary to Pieris, Anticalin proteins are a novel class of therapeutics validated in the clinic and by partnerships with leading pharmaceutical companies, including AstraZeneca, Seagen, and Servier. Anticalin® is a registered trademark of Pieris. For more information, visit www.pieris.com.
ANTICALIN PROTEINS IN IMMUNO-ONCOLOGY
https://www.pieris.com/pipeline/immuno-oncology/anticalin-proteins-in-immuno-oncology
Seagen invests $13M in Pieris, inks deal for PRS-343 + Tuksya in gastric cancer
Mar. 25, 2021 8:33 AM ET Pieris Pharmaceuticals, Inc. (PIRS) By: Mamta Mayani, SA News Editor
- Pieris Pharmaceuticals (NASDAQ:PIRS) soars 15% premarket after Seagen (NASDAQ:SGEN) makes a strategic equity investment in the company as part of an ongoing collaboration between them.
- https://seekingalpha.com/news/3676224-seagen-invests-13m-in-pieris-inks-deal-for-prs-343-tuksya-in-gastric-cancer
- https://seekingalpha.com/symbol/PIRS
- https://seekingalpha.com/symbol/SGEN
TUKYSA® (TUCATINIB)
Indication
TUKYSA is indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.
https://www.seagen.com/medicines/tukysa
Anti-LAG-3 Antibody Relatlimab and Opdivo (nivolumab)
Bristol Myers Squibb Announces RELATIVITY-047, a Trial Evaluating Anti-LAG-3 Antibody Relatlimab and Opdivo (nivolumab) in Patients with Previously Untreated Metastatic or Unresectable Melanoma, Meets Primary Endpoint of Progression-Free Survival
MAR 25, 2021
First Phase 3 data to be reported from a trial evaluating an anti-LAG-3 antibody
Relatlimab is the company’s third distinct checkpoint inhibitor to demonstrate a benefit for patients
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced primary results from the Phase 2/3 RELATIVITY-047 (CA224-047) trial evaluating the fixed-dose combination of relatlimab, an anti-LAG-3 antibody, and Opdivo (nivolumab) versus Opdivo alone in patients with previously untreated metastatic or unresectable melanoma. The trial met its primary endpoint of progression-free survival (PFS). Follow up for overall survival, a secondary endpoint, is ongoing. The fixed-dose combination was well-tolerated and there were no new safety signals reported in either the relatlimab and Opdivo combination arm or the Opdivo arm. These are the first Phase 3 data to be reported from a trial evaluating an anti-LAG-3 antibody. Relatlimab is the third distinct checkpoint inhibitor (anti-PD-1, anti-CTLA-4 and anti-LAG-3) for Bristol Myers Squibb and, with Opdivo, the first fixed-dose combination to demonstrate a benefit for patients.
Anti-LAG-3 Antibody Relatlimab and Opdivo (nivolumab)
About RELATIVITY-047 (CA224-047)
RELATIVITY-047 (CA224-047) is a randomized, double-blind Phase 2/3 study evaluating the fixed-dose combination of relatlimab and Opdivo in patients with previously untreated metastatic or unresectable melanoma versus Opdivo alone. The primary endpoint of the trial is progression-free survival (PFS) by Blinded Independent Central Review (BICR) and the secondary endpoints are overall survival (OS) and objective response rate (ORR). A total of 714 patients were randomized 1:1 to receive a fixed-dose combination of relatlimab 160 mg and Opdivo 480 mg or Opdivo 480 mg by intravenous infusion every four weeks until disease recurrence, unacceptable toxicity or withdrawal of consent. Follow up for the secondary endpoints of OS and ORR is ongoing.
About Opdivo ®
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.
Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.
In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.
INDICATIONS
OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of patients with unresectable or metastatic melanoma.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of patients with intermediate or poor risk advanced renal cell carcinoma (RCC).
OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.
OPDIVO® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab) is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
OPDIVO® (nivolumab) is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
Please see US Full Prescribing Information for OPDIVO and YERVOY.
For more information about Bristol Myers Squibb, visit us at BMS.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20210325005311/en/
Bristol Myers’ anti-LAG-3 antibody achieves primary endpoint in melanoma trial
Mar. 25, 2021 7:18 AM ET
Bristol-Myers Squibb Company (BMY)
By: Dulan Lokuwithana, SA News Editor
- Bristol Myers Squibb (NYSE:BMY) announces that its Phase 2/3 RELATIVITY-047 trial for combination therapy of relatlimab, and Opdivo (nivolumab) has achieved the primary endpoint in patients with previously untreated metastatic or unresectable melanoma.
- https://seekingalpha.com/news/3676126-bristol-myers-anti-lag-3-antibody-achieves-primary-endpoint-melanoma-trial
- https://seekingalpha.com/symbol/BMY
ORGOVYX™ (relugolix)
MYOVANT SCIENCES AND PFIZER ANNOUNCE POSITIVE DATA FROM PHASE 3 LIBERTY RANDOMIZED WITHDRAWAL STUDY OF ONCE-DAILY RELUGOLIX COMBINATION THERAPY IN WOMEN WITH UTERINE FIBROIDS
Wednesday, March 24, 2021 - 06:30amEST
- 78.4% of women who continued on relugolix combination therapy remained responders (menstrual blood loss < 80 mL) through Week 76 compared with 15.1% of women who discontinued treatment at Week 52 (p < 0.0001)
- 69.8% of women who continued relugolix combination therapy remained responders through Week 104
- 88.3% of women who discontinued treatment relapsed with heavy menstrual bleeding, on average 5.9 weeks after discontinuation
- Myovant to host conference call and webcast today at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time
BASEL, Switzerland and NEW YORK, March 24, 2021 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced positive data from the Phase 3 LIBERTY randomized withdrawal study of relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with uterine fibroids. This study was designed to assess the safety and efficacy of continued treatment with relugolix combination therapy for up to two years.
“Since many women with uterine fibroids spend years struggling to manage their symptoms, there is a critical need for non-invasive long-term treatment options,” said Ayman Al-Hendy, M.D., Ph.D., Professor of Obstetrics and Gynecology, University of Chicago and LIBERTY Program Steering Committee Member. “Data from the LIBERTY randomized withdrawal study demonstrate the potential value of continued treatment for women with uterine fibroids, with those receiving relugolix combination therapy in the study experiencing meaningful symptom relief for up to two years.”
ORGOVYX™ (relugolix)
The LIBERTY randomized withdrawal study met its primary endpoint with 78.4% of women who continued on relugolix combination therapy achieving the sustained responder rate (menstrual blood loss < 80 mL) through Week 76 compared with 15.1% of women who discontinued treatment and initiated placebo at Week 52 (p < 0.0001). All three key secondary endpoints in the LIBERTY randomized withdrawal study were also achieved, including sustained responder rate at two years (Week 104), time to relapse of heavy menstrual bleeding, and amenorrhea rate (all p < 0.0001). Through two years, 69.8% of women who continued on relugolix combination therapy remained responders. 88.3% of women who discontinued treatment at Week 52 relapsed with heavy menstrual bleeding, with a median time of return to heavy menstrual bleeding of 5.9 weeks.
Bone mineral density was maintained through two years in the subset of women continuously treated with relugolix combination therapy (N = 31). The incidence of adverse events over one additional year of treatment was consistent with those observed in prior studies, with no new safety signals observed. The most commonly reported adverse event in at least 10% of women treated with relugolix combination therapy was nasopharyngitis.
Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under review by the U.S. Food and Drug Administration (FDA) for the treatment of women with uterine fibroids, with a decision expected by the June 1, 2021 target action date.
About the Phase 3 LIBERTY Program in Uterine Fibroids
The Phase 3 clinical program for uterine fibroids consisted of two multinational, replicate pivotal clinical studies (LIBERTY 1 and LIBERTY 2) of relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with heavy menstrual bleeding associated with uterine fibroids for 24 weeks. Eligible women who completed the LIBERTY 1 or LIBERTY 2 studies were offered the opportunity to enroll in an active treatment extension study in which all women received relugolix combination therapy for an additional 28-week period for a total treatment period of 52 weeks, designed to evaluate the safety and efficacy of longer-term treatment. Upon completion of this 52-week total treatment period, eligible women could elect to participate in a second 52-week randomized withdrawal study designed to provide two-year safety and efficacy data on relugolix combination therapy and to evaluate the need for maintenance therapy. Across studies, a response was defined as a menstrual blood loss volume of less than 80 mL and a 50% or greater reduction from baseline in menstrual blood loss volume during the last 35 days of treatment measured using the alkaline hematin method.
LIBERTY 1 and 2 met their primary endpoints (p < 0.0001) with 73.4% and 71.2% of women receiving relugolix combination therapy achieving the responder criteria compared with 18.9% and 14.7% of women receiving placebo at 24 weeks, respectively. On average, women receiving relugolix combination therapy in both studies experienced an 84.3% reduction in menstrual blood loss from baseline at Week 24 (p < 0.0001). Bone mineral density was comparable between the relugolix combination therapy and placebo groups in LIBERTY 1 and 2. The distribution of the change in bone mineral density, including outliers, was similar for the relugolix combination therapy and placebo groups at 24 weeks, as assessed by dual energy x-ray absorptiometry (DXA). The overall incidence of adverse events in the relugolix combination and placebo groups was comparable in both studies.
The open-label extension study also met its primary endpoint with relugolix combination therapy demonstrating an 87.7% response rate at one year, showing the durability of the response observed in LIBERTY 1 and 2. In addition, women experienced, on average, an 89.9% reduction in menstrual blood loss from baseline at Week 52. Changes in bone mineral density through one year, as assessed by DXA every three months, were consistent with LIBERTY 1 and 2. The incidence of adverse events over one year was consistent with that observed in LIBERTY 1 and 2, with no new safety signals observed.
For more information, please visit our website at www.myovant.com
to learn more, please visit us on www.Pfizer.com
Pfizer, Myovant Sciences' relugolix combo shows positive action in uterine fibroids
Mar. 24, 2021 6:54 AM ET Pfizer Inc. (PFE) By: Mamta Mayani, SA News Editor
- Myovant Sciences (NYSE:MYOV) and Pfizer (NYSE:PFE) announce positive data from Phase 3 LIBERTY withdrawal study of relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with uterine fibroids.
- https://seekingalpha.com/news/3675564-pfizer-myovant-sciences-relugolix-combo-shows-positive-action-in-uterine-fibroids
- https://seekingalpha.com/symbol/PFE
- https://seekingalpha.com/symbol/MYOV
What is ORGOVYX?
ORGOVYX is a prescription medicine used in adults for the treatment of advanced prostate cancer.
It is not known if ORGOVYX is safe or effective in females or children.
Please see full Prescribing Information and Patient Product Information for ORGOVYX.
GAVRETO® (pralsetinib)
CStone Announces New Drug Approval of GAVRETO® (pralsetinib) as First Selective RET Inhibitor in China, Providing a New Therapy for a Subset of Non-Small Cell Lung Cancer Patients
Times：2021.03.24 Author：CStone
- GAVRETO has been approved for the treatment of adults with locally advanced or metastatic RET fusion-positive non-small cell lung cancer after platinum-based chemotherapy
- GAVRETO is the first approved selective RET inhibitor in China and first approved precision therapy for CStone
SUZHOU, China, March 24, 2021 - - CStone Pharmaceuticals (CStone, HKEX: 2616), a leading biopharmaceutical company focused on developing and commercializing innovative immuno-oncology therapies and precision medicines, today announces that the National Medical Products Administration (NMPA) of China has approved GAVRETO® (pralsetinib) capsules for the treatment of adult patients with locally advanced or metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) after platinum-based chemotherapy. Discovered by CStone’s partner Blueprint Medicines, GAVRETO is China’s first approved selective RET inhibitor, as well as CStone’s first approved precision therapy in China.
Dr. Frank Jiang, Chairman and CEO of CStone, noted: “This is a key milestone for CStone. The approval of GAVRETO in China reflects CStone’s commitment to research and develop innovative therapies to meet patients’ unmet medical needs as well as strong execution capabilities. We would like to thank all the patients and investigators involved in the clinical study and extend our gratitude to the NMPA and other government authorities for their support in the priority review leading to the fast approval of GAVRETO. We continue to advance the development of GAVRETO in other indications such as first-line NSCLC, thyroid cancer and other solid tumors, aiming to bring the treatment to more patients soon.”
GAVRETO® (pralsetinib)
About GAVRETO (pralsetinib)
GAVRETO (pralsetinib) is a once-daily oral targeted therapy approved by the NMPA of China for the treatment of adults with locally advanced or metastatic rearranged during transfection (RET) fusion-positive NSCLC after platinum-based chemotherapy.
GAVRETO has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with metastatic RET fusion-positive NSCLC as detected by an FDA approved test, adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC), and adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
GAVRETO is not approved for the treatment of any other indication in China by the NMPA or in the U.S. by the FDA, or for any indication in any other jurisdiction by any other health authority.
GAVRETO is designed to selectively and potently target oncogenic RET alterations, including secondary RET mutations predicted to drive resistance to treatment. In preclinical studies, GAVRETO inhibited RET at lower concentrations than other pharmacologically relevant kinases, including VEGFR2, FGFR2, and JAK2.
Blueprint Medicines and Roche are co-developing GAVRETO globally (excluding Greater China) for the treatment of patients with RET-altered NSCLC, thyroid cancer, and other solid tumors. Blueprint Medicines and Genentech, a member of the Roche Group, are co-commercializing GAVRETO in the U.S., and Roche has exclusive commercialization rights for GAVRETO outside of the U.S. (excluding greater China). The European Medicines Agency validated a marketing authorization application for GAVRETO for the treatment of RET fusion-positive NSCLC, and the review is ongoing. The FDA granted breakthrough therapy designation to GAVRETO for the treatment of RET fusion-positive NSCLC that has progressed following platinum-based chemotherapy and for RET mutation-positive MTC that requires systemic treatment and for which there are no alternative treatments.
Blueprint Medicines partner CStone wins Chinese approval for lung cancer therapy
Mar. 24, 2021 11:04 AM ET CStone Pharmaceuticals (CSPHF) By: Dulan Lokuwithana, SA News Editor
- CStone Pharmaceuticals (OTCPK:CSPHF) announced that the National Medical Products Administration (“NMPA”) of China has approved Gavreto (pralsetinib) for the treatment of a certain group of adult patients with non-small cell lung cancer (“NSCLC”).
- https://seekingalpha.com/news/3675725-blueprint-medicines-partner-cstone-wins-chinese-approval-for-lung-cancer-therapy
- https://seekingalpha.com/symbol/CSPHF
- https://www.blueprintmedicines.com/
- https://seekingalpha.com/symbol/BPMC
- https://www.blueprintmedicines.com/pipeline/clinical-programs/
- https://www.gavreto.com/
biotecMAX™ January/ February/March 2021 Insight
REGEN-COV (casirivimab with imdevimab)
March 23, 2021 at 2:00 AM EDT Back
PHASE 3 TRIAL SHOWS REGEN-COV™ (CASIRIVIMAB WITH IMDEVIMAB) ANTIBODY COCKTAIL REDUCED HOSPITALIZATION OR DEATH BY 70% IN NON-HOSPITALIZED COVID-19 PATIENTS
TARRYTOWN, N.Y., March 23, 2021 /PRNewswire/ --
REGEN-COV also significantly shortened the duration of symptoms by 4 days
All doses (8,000 mg, 2,400 mg and 1,200 mg) had similar efficacy across all endpoints
Companion dose-ranging Phase 2 trial showed significant and comparable viral reductions for all REGEN-COV doses tested, including as low as 300 mg
FDA recently updated U.S. EUA fact sheets for all authorized monoclonal antibody treatments, indicating that REGEN-COV is the only one to retain potency against key emerging variants
Regeneron will share new data with regulatory authorities immediately and request that a lower 1,200 mg dose be added to EUA
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive topline results from the largest trial to date assessing a COVID-19 treatment in infected non-hospitalized patients (n=4,567). This definitive Phase 3 outcomes trial in high-risk non-hospitalized COVID-19 patients ("outpatients") met its primary endpoint, showing the investigational REGEN-COV™ (casirivimab with imdevimab) significantly reduced the risk of hospitalization or death by 70% (1,200 mg intravenous [IV]) and 71% (2,400 mg IV) compared to placebo.
This is a landmark moment in the fight against COVID-19 as this large well-controlled trial provides conclusive results demonstrating that REGEN-COV can dramatically reduce the risk of hospitalization and death in the outpatient setting," said Suraj Saggar, D.O., trial investigator and Chief of Infectious Disease at Holy Name Medical Center in Teaneck, New Jersey. "With so many people still getting infected, as well as recent data showing that REGEN-COV addresses emerging variants, these data underscore the need to rapidly adopt REGEN-COV as standard-of-care to offer high-risk patients their best chance to reduce serious consequences like hospitalization or death."
REGEN-COV also met all secondary endpoints in the Phase 3 outcomes trial, including the ability to reduce symptom duration. In addition, a companion Phase 2 trial showed that even the lowest doses tested (IV: 300 mg; subcutaneous [SC]: 600 mg) had significant viral load reductions over the first 7 study days, comparable to the 2,400 mg and 1,200 mg IV doses.
"With approximately 60,000 newly diagnosed individuals in the U.S. every day and 40,000 still in the hospital because of COVID-19, we are committed to working with the government, healthcare providers and others to support rapid and widespread adoption of REGEN-COV in appropriate patients," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. "We will discuss the new data with regulatory authorities and request that the 1,200 mg dose be rapidly added to the U.S. Emergency Use Authorization, in order for the anticipated REGEN-COV supply to be available to treat even more patients. These Phase 3 data will also form the basis of a full Biologics License Application."
REGEN-COV (casirivimab with imdevimab)
About the REGEN-COV Antibody Cocktail
REGEN-COV (casirivimab with imdevimab) is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987) that was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19, using Regeneron's proprietary VelocImmune® and VelociSuite® technologies. The two potent, virus-neutralizing antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science.
Under an EUA issued by the FDA, REGEN-COV is currently available in the U.S. to treat mild-to-moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization.
REGEN-COV is currently authorized and available in a 2,400 mg IV dose, with infusion times as short as 20 minutes. The criteria for 'high-risk' patients are described in the Fact Sheet for Healthcare Providers. In the U.S., REGEN-COV is not authorized for use in patients who are hospitalized due to COVID-19 or require oxygen therapy, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19.
Regeneron is collaborating with Roche to increase global supply of REGEN-COV. Regeneron is responsible for development and distribution of the treatment in the U.S., and Roche is primarily responsible for development and distribution outside the U.S. The companies share a commitment to making the antibody cocktail available to COVID-19 patients around the globe and will support access in low- and lower-middle-income countries through drug donations to be made in partnership with public health organizations.
About Regeneron's VelocImmune Technology
Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create approximately a quarter of all original, FDA-approved fully human monoclonal antibodies currently available. This includes REGEN-COVTM (casirivimab with imdevimab), Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza™ (evinacumab-dgnb) and Inmazeb™ (atoltivimab, maftivimab and odesivimab-ebgn
Authorized Emergency Use
REGEN-COV, (casirivimab with imdevimab to be administered together) is authorized for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. [see Limitations of Authorized Use]
- REGEN-COV has not been approved, but has been authorized for emergency use by FDA
- This use is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner
- Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of REGEN-COV and mandatory requirements of the EUA and must comply with the requirements of the EUA. The FDA Letter of Authorization is available for reference, as well as the Dear Healthcare Provider Letter and Patient Fact Sheet
For additional information about the company, please visit www.regeneron.com
SOURCE Regeneron Pharmaceuticals, Inc.
Regeneron's COVID-19 antibody reduces hospitalization, death by 70%
Mar. 23, 2021 2:47 AM ET Regeneron Pharmaceuticals, Inc. (REGN) By: Mamta Mayani, SA News Editor2 Comments
- Regeneron Pharmaceuticals (NASDAQ:REGN) announces positive topline results from Phase 3 outcomes trial assessing a COVID-19 treatment in infected non-hospitalized patients (n=4,567).
https://seekingalpha.com/symbol/REGN
US trial of Oxford-AstraZeneca vaccine confirms safety and effectiveness - BBC News
•Mar 22, 2021 BBC News
Results from the long-awaited US trial of the Oxford-AstraZeneca Covid vaccine have confirmed that the shot is both safe and highly effective. The vaccine was 79% effective at stopping symptomatic Covid and 100% effective at preventing people from falling seriously ill. There were also no safety issues regarding blood clots. More than 32,000 volunteers took part in the study, mostly in America, but also in Chile and Peru.
U.S. study finds AstraZeneca vaccine 79% effective against symptomatic COVID-19
Mar 22, 2021 CBS News
Drugmaker AstraZeneca is preparing to request emergency use authorization for its coronavirus vaccine in the U.S. after its latest clinical trial finds the vaccine was fully effective in preventing COVID-19 hospitalizations and 79% effective in stopping symptomatic illness. Dr. Alonzo Plough, chief science officer at the Robert Wood Johnson Foundation, joins CBSN to discuss the potential impact in the fight against the pandemic.
AZD1222
AZD1222 US Phase III primary analysis confirms safety and efficacy
PUBLISHED25 March 2021
25 March 2021 00:45 GMT
76% vaccine efficacy against symptomatic COVID-19
100% efficacy against severe or critical disease and hospitalisation
85% efficacy against symptomatic COVID-19 in participants aged 65 years and over
Positive high-level results from the primary analysis of the Phase III trial of AZD1222 in the US have confirmed vaccine efficacy consistent with the pre-specified interim analysis announced on Monday 22 March 2021.
These results have been presented to the independent Data Safety Monitoring Board. The primary analysis is pre-specified in the protocol and will be the basis for a regulatory submission for Emergency Use Authorization to the US Food and Drug Administration in the coming weeks.
This primary efficacy analysis included the accrual of 190 symptomatic cases of COVID-19 from the 32,449 trial participants, an additional 49 cases to the previously announced interim analysis. Participants were randomised on a 2:1 ratio between the vaccine and placebo group.
Updated analysis finds AstraZeneca vaccine 76% effective against COVID-19
Mar. 24, 2021 10:52 PM ET AstraZeneca PLC (AZN) By: Jonathan M Block, SA News Editor1 Comment
- AstraZeneca (NASDAQ:AZN) Wednesday night said that an updated analysis found that its COVID-19 vaccine is 76% effective at preventing symptomatic disease.
AZD1222 US Phase III trial met primary efficacy endpoint in preventing COVID-19 at interim analysis
PUBLISHED22 March 2021
22 March 2021 07:00 GMT
79% vaccine efficacy at preventing symptomatic COVID-19
100% efficacy against severe or critical disease and hospitalisation
Comparable efficacy result across ethnicity and age,
with 80% efficacy in participants aged 65 years and over
Favourable reactogenicity and overall safety profile
The AstraZeneca US Phase III trial of AZD1222 demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalisation.
This interim safety and efficacy analysis was based on 32,449 participants accruing 141 symptomatic cases of COVID-19. The trial had a 2:1 randomisation of vaccine to placebo.
Vaccine efficacy was consistent across ethnicity and age. Notably, in participants aged 65 years and over, vaccine efficacy was 80%.
The vaccine was well tolerated, and the independent data safety monitoring board (DSMB) identified no safety concerns related to the vaccine. The DSMB conducted a specific review of thrombotic events, as well as cerebral venous sinus thrombosis (CVST) with the assistance of an independent neurologist. The DSMB found no increased risk of thrombosis or events characterised by thrombosis among the 21,583 participants receiving at least one dose of the vaccine. The specific search for CVST found no events in this trial.
Ann Falsey, Professor of Medicine, University of Rochester School of Medicine, US, and co-lead Principal Investigator for the trial, said: “These findings reconfirm previous results observed in AZD1222 trials across all adult populations but it’s exciting to see similar efficacy results in people over 65 for the first time. This analysis validates the AstraZeneca COVID-19 vaccine as a much-needed additional vaccination option, offering confidence that adults of all ages can benefit from protection against the virus.”
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “These results add to the growing body of evidence that shows this vaccine is well tolerated and highly effective against all severities of COVID-19 and across all age groups. We are confident this vaccine can play an important role in protecting millions of people worldwide against this lethal virus. We are preparing to submit these findings to the US Food and Drug Administration and for the rollout of millions of doses across America should the vaccine be granted US Emergency Use Authorization.”
AstraZeneca will continue to analyse the data and prepare for the primary analysis to be submitted to the US Food and Drug Administration for Emergency Use Authorization in the coming weeks. In parallel, the primary analysis will be submitted for publication in a peer-reviewed journal.
Amongst participants in the interim analysis, approximately 79% were white/Caucasian, 8% black/African American, 4% native American and 4% Asian, and 22% of participants were Hispanic.
AZD1222
AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.
In May 2020, AstraZeneca received support of more than $1bn from BARDA for the development, production and delivery of the vaccine under an agreement with the US Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense. The Phase III D8110C00001 trial is part of this funding agreement.
The vaccine has been granted a conditional marketing authorisation or emergency use in more than 70 countries across six continents, and with the Emergency Use Listing granted by the World Health Organization this accelerates the pathway to access in up to 142 countries through the COVAX Facility.
D8110C000011
The US Phase III trial, called D8110C00001, was led by AstraZeneca and funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response (ASPR) at the US Department of Health and Human Services (HHS) in collaboration with the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) and the Army Contracting Command, and the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health. The NIAID-supported COVID-19 Prevention Network (CoVPN) participated in the trial.
D8110C00001 is a Phase III randomised, double-blind, placebo-controlled multicentre study assessing the safety, efficacy, and immunogenicity of AZD1222 compared to placebo for the prevention of COVID-19, in 32,449 participants across 88 trial centres in the US, Peru and Chile. Trial participants aged 18 years or over who are healthy or have medically stable chronic diseases and are at increased risk for being exposed to the SARS-CoV-2 virus and COVID-19 were randomised in a 2:1 ratio to receive two intramuscular doses of either 5 x1010 viral particles of AZD1222 or saline placebo four weeks apart.
To learn more about BARDA’s support for the COVID-19 pandemic response, visit medicalcountermeasures.gov.
To learn more about JPEO-CBRND’s COVID-19 response, visit https://www.jpeocbrnd.osd.mil/coronavirus.
Please visit astrazeneca.com
AstraZeneca COVID-19 shot shows 79% efficacy;
Mar. 22, 2021 7:47 AM ET AstraZeneca PLC (AZN) By: Dulan Lokuwithana, SA News Editor40 Comments
- Amid rare occurrences of blood clot formation following its inoculation, AstraZeneca (NASDAQ:AZN) today announced advanced trial data from the US study for its COVID-19 shot indicating an efficacy of ~79% at preventing symptomatic COVID-19.
- https://seekingalpha.com/news/3674697-moderna-and-biontech-lower-after-astrazeneca-releases-us-trial-data-for-covid-19-shot
- https://seekingalpha.com/symbol/AZN
#AstraZeneca #CovidVaccine #MSNBC
AstraZeneca Covid Vaccine Found To Be Effective Against Severe Cases | Stephanie Ruhle | MSNBC
•Mar 22, 2021 MSNBC
Dr. Kavita Patel discusses the new data showing how effective the AstraZeneca Covid-19 vaccine is at preventing severe and fatal cases and why some may be hesitant to receive it. Aired on 03/22/2021.
AstraZeneca: US data shows vaccine effective for all adults
By MARIA CHENG and LAURAN NEERGAARD
AstraZeneca Vaccine Is 79% Effective in U.S. Study
The vaccine maker is preparing to apply for emergency authorization from the Food and Drug Administration.
https://www.nytimes.com/live/2021/03/22/world/covid-vaccine-coronavirus-cases
AstraZeneca vaccine found to be 79% effective in U.S. trial
Mar 22, 2021 CNBC Television
The findings of a large U.S. trial have shown that the coronavirus vaccine developed by AstraZeneca and the University of Oxford is 79% effective in preventing symptomatic illness and 100% effective against severe disease and hospitalization. CNBC's Meg Tirrell reports. For access to live and exclusive video from CNBC subscribe to CNBC PRO: https://cnb.cx/2NGeIvi The findings of a large U.S. trial have shown that the coronavirus vaccine developed by AstraZeneca and the University of Oxford is 79% effective in preventing symptomatic illness and 100% effective against severe disease and hospitalization. The safety and efficacy analysis of the AstraZeneca vaccine, published Monday, was based on 32,449 participants across 88 trial centers in the U.S., Peru and Chile. Data from the late-stage human trial study reaffirms that the Oxford-AstraZeneca vaccine is safe and highly effective. By comparison, Moderna’s vaccine has been found to be more than 94% effective in preventing Covid and Pfizer-BioNTech’s vaccine was found to be 95% effective. AstraZeneca said it will continue to analyze the data and prepare for the primary analysis to be submitted to the U.S. Food and Drug Administration for emergency use authorization in the coming weeks. The results come shortly after several countries temporarily suspended the use of the shot following reports of blood clots in some vaccinated people. Health experts sharply criticized the move, citing a lack of data, while analysts expressed concern about the impact on vaccine uptake as the virus continues to spread. Germany, France, Italy and Spain are among those to have resumed use of the Oxford-AstraZeneca vaccine after Europe’s drug regulator said its initial investigation of possible side effects concluded the shot is safe and effective. The World Health Organization and the International Society on Thrombosis and Hemostasis have recommended that countries continue to use the Oxford-AstraZeneca vaccine. AstraZeneca said in a release Monday that an independent board identified no safety concerns related to the shot. It also conducted a specific review of blood clots as well as cerebral venous sinus thrombosis, an extremely rare blood clot in the brain, with the help of an independent neurologist. The data safety monitoring board “found no increased risk of thrombosis or events characterised by thrombosis among the 21,583 participants receiving at least one dose of the vaccine. The specific search for CVST found no events in this trial.” AstraZeneca to file for emergency use next month “We are thrilled by the results we have disclosed this morning,” Ruud Dobber, executive vice president of AstraZeneca’s biopharmaceuticals business unit, told CNBC’s “Squawk Box” on Monday. “The plan is to file in the first half of April for the emergency use authorization and, of course, then it is in the hands of the FDA how fast they can decide about the approval. Assuming that the approval will take place in a fast way, we hope to deliver 30 million doses instantly after the EUA for Americans to get vaccinated,” Dobber said. When asked how AstraZeneca would tackle the prospect of lingering safety concerns following reports of blood clots in some vaccinated people, Dobber replied: “As always, and I think I speak on behalf of all manufacturers, patient safety is our number one priority.” “It was very pleasing to see that even with a magnifying glass the data safety monitoring board didn’t see any imbalance between the vaccinated group and the placebo group. So, that gives us a lot of confidence.”
Tecentriq ® (atezolizumab)
Sunday, Mar 21, 2021
Pivotal Phase III Study Shows Genentech’s Tecentriq Helped People With Early Lung Cancer Live Longer Without Their Disease Returning
First Phase III study to show that a cancer immunotherapy improves disease-free survival in people with resectable early stage lung cancer compared to best supportive care
Treating lung cancer early, before it has spread, may help prevent the disease from returning and therefore provide the best opportunity for a cure
Data will be submitted to health authorities globally, including the U.S. Food and Drug Administration and the European Medicines Agency, and presented at an upcoming medical meeting
South San Francisco, CA -- March 21, 2021 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMpower010 study evaluating Tecentriq ® (atezolizumab), compared with best supportive care (BSC), met its primary endpoint of disease-free survival (DFS) at the interim analysis. Tecentriq showed a statistically significant improvement in DFS as adjuvant therapy following surgery and chemotherapy in all randomized Stage II-IIIA populations with non-small cell lung cancer (NSCLC). The magnitude of DFS benefit was particularly pronounced in the PD-L1-positive population.
About the IMpower010 study
IMpower010 is a Phase III, global, multicenter, open-label, randomized study evaluating the efficacy and safety of Tecentriq compared with BSC, in participants with Stage IB-IIIA NSCLC (UICC 7th edition), following surgical resection and up to 4 cycles of adjuvant cisplatin-based chemotherapy. The study randomized 1,005 people with a ratio of 1:1 to receive either at most 16 cycles of Tecentriq or BSC. The primary endpoint is investigator-determined DFS in the PD-L1-positive Stage II-IIIA, all randomized Stage II-IIIA and ITT Stage IB-IIIA populations. Key secondary endpoints include OS in the overall study population, ITT Stage IB-IIIA NSCLC.
Tecentriq ® (atezolizumab)
About Tecentriq ® (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.
Tecentriq U.S. Indications
Tecentriq is a prescription medicine used to treat adults with:
A type of lung cancer called non-small cell lung cancer (NSCLC).
- Tecentriq may be used alone as their first treatment when their lung cancer:
- has spread or grown, and
- their cancer tests positive for “high PD-L1”, and
- their tumor does not have an abnormal “EGFR” or “ALK” gene
- Tecentriq may be used with the medicines bevacizumab, paclitaxel, and carboplatin as their first treatment when their lung cancer:
- has spread or grown, and
- is a type called “non-squamous NSCLC,” and
- their tumor does not have an abnormal “EGFR” or “ALK” gene
- Tecentriq may be used with the medicines paclitaxel protein-bound and carboplatin as their first treatment when their lung cancer:
- has spread or grown, and
- is a type called “non-squamous NSCLC,” and
- their tumor does not have an abnormal “EGFR” or “ALK” gene
- Tecentriq may also be used when their lung cancer:
- has spread or grown, and
- they have tried chemotherapy that contains platinum, and it did not work or is no longer working
- if their tumor has an abnormal “EGFR” or “ALK” gene, they should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working
A type of lung cancer called small cell lung cancer (SCLC).
- Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as their first treatment when their lung cancer:
- is a type called “extensive-stage small cell lung cancer,” which means that it has spread or grown
It is not known if Tecentriq is safe and effective in children.
Please see http://www.Tecentriq.com for full Prescribing Information and additional Important Safety Information.
For more information visit http://www.gene.com/cancer-immunotherapy.
For additional information about the company, please visit http://www.gene.com.
Genentech's Tecentriq meets late-stage lung cancer study main goal
Mar. 22, 2021 6:29 AM ETRoche Holding AG (RHHBY)By: Aakash Babu, SA News Editor1 Comment
- Roche (OTCQX:RHHBY) company Genentech announces that the Phase III IMpower010 study evaluating Tecentriq (atezolizumab), compared with best supportive care (BSC), met its main goal of disease-free survival (DFS) in certain patients with non-small cell lung cancer (NSCLC) at the interim analysis.
- https://seekingalpha.com/news/3674651-genentechs-tecentriq-meets-late-stage-lung-cancer-study-main-goal
- https://seekingalpha.com/symbol/RHHBY
EXPAREL® (BUPIVACAINE LIPOSOME INJECTABLE SUSPENSION)
PACIRA ANNOUNCES FDA APPROVAL OF SUPPLEMENTAL NEW DRUG APPLICATION FOR EXPAREL® (BUPIVACAINE LIPOSOME INJECTABLE SUSPENSION) IN PEDIATRIC PATIENTS
-- EXPAREL is the first and only FDA-approved long-acting local analgesic for children aged six and over –
-- Conference call tomorrow at 8:30 a.m. ET --
PARSIPPANY, N.J., March 22, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced the U.S. Food and Drug Administration (FDA) has approved the submission of its supplemental new drug application (sNDA) seeking expansion of the EXPAREL label to include use in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia. With this approval, EXPAREL is the first and only FDA approved long-acting local analgesic for the pediatric population as young as age six.
EXPAREL® (BUPIVACAINE LIPOSOME INJECTABLE SUSPENSION)
“The current standard of care for managing moderate-to-severe pain in children is opioids, which often come with unwanted severe and possibly life-threatening side effects in this vulnerable patient population,” said Dave Stack, Chairman and Chief Executive Officer at Pacira. “In line with our corporate mission to provide an opioid alternative to as many patients as possible, we are grateful for the opportunity to give clinicians and patients a new, safe and effective option for achieving long-lasting non-opioid pain control in children without the need for an indwelling catheter and pump.”
Since initial approval in 2011, more than 8 million patients have been treated with EXPAREL. With approximately one million pediatric procedures per year where opioids, catheters and pain pumps are the mainstay of postsurgical pain control, there is an urgent unmet need for opioid alternatives.
“There has been a significant gap in our pain control armamentarium as it relates to the ability to safely and effectively provide long-lasting non-opioid pain control for the pediatric surgical population,” said Christopher Tirotta, MD, Chief of Anesthesiology at Nicklaus Children's Hospital and an investigator in the pivotal PLAY study. “Traditional local anesthetics have not provided a duration of pain control that matches the time course of the most significant postsurgical pain, which has necessitated the reliance on opioids in an attempt to manage pain. With the addition of EXPAREL as an FDA-approved non-opioid option to provide prolonged pain control we are better equipped to treat our pediatric patients while reducing opioid exposure, and ultimately improving outcomes.”
The sNDA was based on the positive data from the Phase 3 PLAY study of EXPAREL infiltration in pediatric patients undergoing spinal or cardiac surgeries. Overall findings were consistent with the pharmacokinetic and safety profiles for adult patients with no safety concerns identified at a dose of 4 mg/kg. The PLAY study enrolled 98 patients to evaluate safety and the pharmacokinetics of EXPAREL for two patient groups: patients aged 12 to less than 17 years and patients aged 6 to less than 12 years. Per FDA guidance, the primary objectives of the PLAY study were to evaluate the pharmacokinetics and safety of EXPAREL.
“Moderate-to-severe postsurgical pain is experienced by 40% of hospitalized children, and every scoliosis patient I treat surgically. Over and under treated pain in pediatric patients is a significant cause of morbidity after surgery,” said Peter Newton, MD, Chief of the Division of Orthopedics & Scoliosis at Rady Children's Hospital-San Diego and Clinical Professor at UC San Diego School of Medicine. “Opioids are responsible for 50% of postsurgical respiratory failure events in children, and often cause unpleasant side effects delaying a patient’s recovery after surgery. This FDA approval is a remarkable victory for pediatric patients and their families and paves the way for opioid-minimizing pain management protocols in children undergoing surgery.”
About EXPAREL®
EXPAREL (bupivacaine liposome injectable suspension) is indicated in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia, and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. The product combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.
FDA OKs expanded use of Pacira's Exparel in pediatric patients
Mar. 23, 2021 4:12 AM ET
Pacira BioSciences, Inc. (PCRX)
By: Mamta Mayani, SA News Editor
- The FDA has approved Pacira BioSciences' (NASDAQ:PCRX) supplemental new drug application (sNDA) seeking expansion of the Exparel label to include use in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia.
- https://seekingalpha.com/news/3675071-fda-oks-expanded-use-of-paciras-exparel-in-pediatric-patients
- https://seekingalpha.com/symbol/PCRX
Mar 20, 2021
Insulet’s Omnipod® 5 Automated Insulin Delivery System Improves Clinical Outcomes in Type 1 Diabetes
ACTON, Mass.--(BUSINESS WIRE)--Mar. 20, 2021-- Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, today announced positive results from the first pivotal trial for the Omnipod® 5 Automated Insulin Delivery System. Omnipod 5, the world’s first tubeless, wearable system that continuously adapts insulin delivery based on glucose levels and trends, significantly improved time in range and reduced HbA1c in children, adolescents, and adults, aged 6-70 years, with type 1 diabetes. The data was presented at ENDO 2021, the Endocrine Society’s annual meeting and a leading forum for endocrinology research and clinical care worldwide.
Omnipod 5 System Pivotal Study Overview
Insulet presented its data in two groups of type 1 diabetes patients: 128 adults and adolescents between 14 and 70 years old, and 112 children age 6 to 13.9 years. The participants used the Omnipod 5 System at home for a period of 3 months after a 14-day period using their standard therapy, which included both pump therapy and multiple daily injections.
The Omnipod 5 System showed a significant increase in time in range (70-180 mg/dL) in the adults and adolescents, from 65% to 74%, or an additional 2.2 hours per day, and an overall reduction of HbA1c from 7.16% to 6.78%. Participants also saw a decrease in mean glucose from 161 to 154 mg/dL. Median time below 70 mg/dL improved from 2.0 to 1.1%. At a target glucose of 110 mg/dL, subjects achieved 76% time in range.
In children, time in range improved from 53% to 68%, corresponding to an additional 3.7 hours per day in target range. Additionally, HbA1c improved from 7.67% to 6.99% and the mean glucose level decreased from 183 to 160 mg/dL. Median time below 70 mg/dL stayed remarkably low at 1.5%.
“The daily management of type 1 diabetes is relentless,” said Jose S., father of a pediatric pivotal trial participant. “Caregivers make multiple decisions each day that profoundly affect their loved one’s wellness and safety. Insulet’s Omnipod 5 System reduces this burden by automating much of the decision making. It also provided me peace of mind by mitigating the threat of hypoglycemia.”
“It was remarkable how quickly every family learned to trust the automation, allowing people to sleep through the night for the first time in years,” said Professor Irl Hirsch, University of Washington. “The significant improvement in glycemic outcomes they achieved with the use of Omnipod 5, including the remarkably low rates of hypoglycemia, led to a tremendous reduction in the burden of care for so many.”
The Omnipod 5 System received breakthrough device designation from the U.S. Food and Drug Administration and is currently under review. The Company expects to launch Omnipod 5 in limited release during the first half of 2021.
For more information, please visit: www.insulet.com and www.omnipod.com.
©2021 Insulet Corporation. Omnipod is a registered trademark of Insulet Corporation in the United States of America and other various jurisdictions. All rights reserved.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210320005001/en/
Insulet’s insulin delivery system shows promise in pivotal trial
Mar. 22, 2021 6:10 AM ET
By: Aakash Babu, SA News Editor
- Insulet (NASDAQ:PODD) announces positive results from the first pivotal trial for the company's Omnipod 5 Automated Insulin Delivery System.
https://seekingalpha.com/symbol/PODD
Meet the Omnipod DASH® Insulin Management System
https://www.omnipod.com/new-to-omnipod
KEYTRUDA® (pembrolizumab) Plus Platinum- and Fluoropyrimidine-Based Chemotherapy
FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Platinum- and Fluoropyrimidine-Based Chemotherapy for Treatment of Certain Patients With Locally Advanced or Metastatic Esophageal or Gastroesophageal Junction (GEJ) Carcinoma
March 23, 2021 6:45 am EST
First Anti-PD-1 in Combination With Chemotherapy Approved for the First-Line Treatment of Esophageal and GEJ Carcinoma, Regardless of Histology or PD-L1 Expression
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy. The approval is based on results from the Phase 3 KEYNOTE-590 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) for KEYTRUDA plus fluorouracil (FU) and cisplatin versus FU and cisplatin alone, regardless of histology or PD-L1 expression status. For OS and PFS, KEYTRUDA plus FU and cisplatin reduced the risk of death by 27% (HR=0.73 [95% CI, 0.62-0.86]; p<0.0001) and reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.55-0.76]; p<0.0001) versus FU and cisplatin alone.The ORR, an additional efficacy outcome measure, was 45% (95% CI, 40-50) for patients who received KEYTRUDA plus FU and cisplatin and 29% (95% CI, 25-34) for those who received FU and cisplatin alone (p<0.0001).
Data Supporting the Approval
The approval was based on data from KEYNOTE-590 (ClinicalTrials.gov, NCT03189719), a multicenter, randomized, placebo-controlled trial that enrolled 749 patients with metastatic or locally advanced esophageal or GEJ (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma who were not candidates for surgical resection or definitive chemoradiation. Patients were randomized (1:1) to receive either KEYTRUDA (200 mg on Day 1 every three weeks) or placebo (on Day 1 every three weeks) in combination with cisplatin (80 mg/m2 on Day 1 every three weeks for up to six cycles) plus FU (800 mg/m2 per day on Days 1 to 5 every three weeks, or per local standard for FU administration, for up to 24 months); all study medications were administered via intravenous infusion.
Randomization was stratified by tumor histology (squamous cell carcinoma vs. adenocarcinoma), geographic region (Asia vs. ex-Asia) and Eastern Cooperative Oncology Group (ECOG) performance status (PS) (0 vs. 1).
Treatment with KEYTRUDA or chemotherapy continued until unacceptable toxicity or disease progression. Patients could be treated with KEYTRUDA for up to 24 months in the absence of disease progression. The major efficacy outcome measures were OS and PFS, as assessed by the investigator according to RECIST v1.1 (modified to follow a maximum of 10 target lesions and a maximum of five target lesions per organ). The study pre-specified analyses of OS and PFS based on squamous cell histology, Combined Positive Score (CPS) ≥10, and in all patients. Additional efficacy outcome measures were ORR and duration of response (DOR), according to modified RECIST v1.1, as assessed by the investigator.
KEYTRUDA® (pembrolizumab) Plus Platinum- and Fluoropyrimidine-Based Chemotherapy
About KEYTRUDA® (pembrolizumab) Injection, 100 mg
KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,400 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.
For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.
About Merck’s Patient Support Program for KEYTRUDA
Merck is committed to helping provide patients and their caregivers support throughout their treatment with KEYTRUDA. The KEY+YOU Patient Support Program provides a range of resources and support. For further information and to sign up, eligible patients may call 85-KEYTRUDA (855-398-7832) or visit www.keytruda.com.
For more information, visit www.merck.com
Please see Prescribing Information for KEYTRUDA (pembrolizumab) at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf and Medication Guide for KEYTRUDA at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210323005359/en/
Merck’s Keytruda authorized for a new indication in esophageal cancer
Mar. 23, 2021 11:22 AM ET
By: Dulan Lokuwithana, SA News Editor2 Comments
- Merck (MRK -1.2%) announced that the FDA has approved Keytruda for the treatment of a group of patients with locally advanced or metastatic esophageal or gastroesophageal junction (“GEJ”) carcinoma.
- https://seekingalpha.com/news/3675276-mercks-keytruda-authorized-for-a-new-indication-in-esophageal-cancer
- https://seekingalpha.com/symbol/MRK
Pemazyre® (pemigatinib)
Incyte Announces Approval of Pemazyre® (pemigatinib) in Japan for the Treatment of Patients with Unresectable Biliary Tract Cancer (BTC) with a Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion Gene, Worsening After Cancer Chemotherapy
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WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (Nasdaq:INCY) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Pemazyre® (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene1, worsening after cancer chemotherapy.
Pemazyre® (pemigatinib)
About FIGHT-202
The FIGHT-202 Phase 2, open-label, multicenter study (NCT02924376) is evaluating the safety and efficacy of pemigatinib – a selective fibroblast growth factor receptor (FGFR) 1, 2, 3 inhibitor – in adult (age ≥ 18 years) patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status.
Patients were enrolled into one of three cohorts – Cohort A (FGFR2 fusions or rearrangements), Cohort B (other FGF/FGFR genetic alterations) or Cohort C (no FGF/FGFR genetic alterations). All patients received 13.5 mg pemigatinib orally once daily (QD) on a 21-day cycle (two weeks on/one week off) until radiological disease progression or unacceptable toxicity.
The primary endpoint of FIGHT-202 is overall response rate (ORR) in Cohort A, assessed by independent review per RECIST v1.1. Secondary endpoints include ORR; progression free survival (PFS), overall survival (OS), duration of response (DOR), disease control rate (DCR) and safety in all cohorts.
For more information about FIGHT-202, visit https://clinicaltrials.gov/ct2/show/NCT02924376.
About Pemazyre® (pemigatinib)
Pemazyre is a kinase inhibitor indicated in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test9. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, worsening after cancer chemotherapy.
Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations.
Pemazyre is marketed by Incyte in the United States and will be marketed by Incyte in Japan. Incyte has granted Innovent Biologics, Inc. rights to develop and commercialize pemigatinib in hematology and oncology in Mainland China, Hong Kong, Macau and Taiwan. Incyte has retained all other rights to develop and commercialize pemigatinib outside of the United States.
Additionally, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the conditional marketing authorization of pemigatinib for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
Pemazyre is a trademark of Incyte Corporation.
For additional information on Incyte, please visit Incyte.com and follow @Incyte.
For more information on Incyte Biosciences Japan G.K., please visit Incyte.jp.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210323005530/en/
Incyte's Pemazyre OK'd in Japan for bile duct cancer
Mar. 23, 2021 6:40 AM ET
By: Mamta Mayani, SA News Editor
- The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Incyte's (NASDAQ:INCY) Pemazyre, a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of patients with unresectable biliary tract cancer (BTC) with FGFR2 fusion gene, worsening after cancer chemotherapy.
- https://seekingalpha.com/news/3675094-incytes-pemazyre-okd-in-japan-for-bile-duct-cancer
- https://seekingalpha.com/symbol/INCY
Vosoritide
BioMarin Announces Oral Presentation at ENDO2021, the Endocrine Society's Annual Meeting, with Data Demonstrating 2 Years of Treatment Benefit in Children with Achondroplasia Treated with VosoritideHeight Gain is Maintained in 2nd Year of Treatment
Mar 20, 2021
SAN RAFAEL, Calif., March 20, 2021 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that data from the open-label long-term extension of the Phase 3 study of 15 µg/kg dose of vosoritide was presented at an oral presentation at ENDO21, the Endocrine Society's Annual Meeting by Professor Ravi Savarirayan, M.B., B.S., M.D., clinical investigator from the Murdoch Children's Research Institute, Royal Children's Hospital, University of Melbourne, Parkville, Victoria. Vosoritide is an investigational, once daily injection analog of C-type Natriuretic Peptide (CNP) for the treatment of achondroplasia, the most common form of disproportionate short stature in humans.
The data from the open-label extension presented at ENDO21 showed that children maintained an increase in Annual Growth Velocity (AGV) through the second year of continuous treatment with vosoritide. Children who received two years of vosoritide therapy had a baseline mean AGV of 4.28 cm/year. After one year of treatment, mean AGV was 5.71 cm/year and after the second year mean AGV was 5.65 cm/year, demonstrating sustained restoration of a major portion of the growth deficit in achondroplasia through the second year of treatment. Children also had an improved height z-score, which is a measure of height relative to that of a similar population of average height.
In the children who were crossed over from placebo to vosoritide in the open-label extension arm, similar efficacy after one year was observed compared to children who received treatment with vosoritide after one year. Children who were crossed over to treatment had a baseline mean AGV of 3.99 cm/year. After one year of treatment, mean AGV was 5.57 cm per year.
Retention of subjects on treatment was high with 93% of patients originally randomized to receive vosoritide remaining on treatment two years later.
Vosoritide Safety
The 2-year data demonstrated that vosoritide, administered at 15ug/kg/day was generally well tolerated with no new safety findings. The majority of adverse events (AEs) were mild and no serious adverse events were reported as study drug-related. Injection site reactions were the most common drug-related AEs, and all were transient. There were no AEs related to disproportionate bone growth or bone pathology. No clinically significant blood pressure decreases or new safety findings were observed.
For additional information, please visit www.biomarin.com.
BioMarin presents data supporting long-term benefit of vosoritide in achondroplasia
Mar. 21, 2021 12:09 AM ET
BioMarin Pharmaceutical Inc. (BMRN)
By: Dulan Lokuwithana, SA News Editor
- BioMarin Pharmaceutical (NASDAQ:BMRN) has announced new Phase 3 data from an open-label long-term extension study to support the lasting treatment benefit of vosoritide in children with achondroplasia. https://seekingalpha.com/news/3674615-biomarin-presents-data-for-long-term-benefit-of-vosoritide-in-achondroplasia https://seekingalpha.com/symbol/BMRN
biotecMAX™ January/ February/March 2021 Insight
KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib)
KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Significantly Improved Progression-Free Survival and Overall Survival Versus Chemotherapy in Patients With Advanced Endometrial Cancer Following Prior Platinum-Based Chemotherapy in Phase 3 Study
March 19, 2021 6:45 am EST
KEYTRUDA Plus LENVIMA Significantly Reduced the Risk of Death by 38%, With a Median Overall Survival of 18.3 Months Versus 11.4 Months With Chemotherapy Regardless of Mismatch Repair Status
First Results From Pivotal KEYNOTE-775/Study 309 Trial Presented at Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women’s Cancer
KENILWORTH, N.J. & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced the first presentation of investigational data from the pivotal Phase 3 KEYNOTE-775/Study 309 trial in an oral plenary session (Plenary Session #10191) at the virtual Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women’s Cancer. The trial evaluated the combination of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for the treatment of certain patients with advanced, metastatic or recurrent endometrial cancer following one prior platinum-based regimen in any setting.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210319005069/en/
Results were similar across the all-comer population and the pMMR subgroup. In the pMMR subgroup, KEYTRUDA plus LENVIMA reduced the risk of disease progression or death by 40% (HR=0.60 [95% CI: 0.50-0.72]; p<0.0001), with a median PFS of 6.6 months (95% CI: 5.6-7.4; number of events=247) versus 3.8 months (95% CI: 3.6-5.0; number of events=238) for patients who received TPC. KEYTRUDA plus LENVIMA reduced the risk of death by 32% (HR=0.68 [95% CI: 0.56-0.84]; p=0.0001), with a median OS of 17.4 months (95% CI: 14.2-19.9; number of events=165) versus 12.0 months (95% CI: 10.8-13.3; number of events=203) for patients who received TPC. The secondary endpoint of ORR was 30.3% (95% CI: 25.5-35.5), with a CR rate of 5.2% and a PR rate of 25.1%, for patients who received KEYTRUDA plus LENVIMA versus 15.1% (95% CI: 11.5-19.3), with a CR rate of 2.6% and a PR rate of 12.5%, for patients who received TPC (ORR difference versus TPC: 15.2 percentage points; p<0.0001). For patients who responded, the median DOR was 9.2 months (range: 1.6-23.7) for patients who received KEYTRUDA plus LENVIMA versus 5.7 months (range: 0.0-24.2) for patients who received TPC.
In the all-comer population, in the KEYTRUDA plus LENVIMA arm (n=406), treatment-emergent adverse events (TEAEs) of any grade led to discontinuation of KEYTRUDA in 18.7% of patients, of LENVIMA in 30.8% of patients, and of both in 14.0% of patients. In the TPC arm (n=388), TEAEs of any grade led to discontinuation of chemotherapy in 8.0% of patients. Grade 5 TEAEs of any cause occurred in 5.7% of patients in the KEYTRUDA plus LENVIMA arm and in 4.9% of patients in the TPC arm. Grade ≥3 TEAEs occurred in 88.9% of patients in the KEYTRUDA plus LENVIMA arm and in 72.7% of patients in the TPC arm. In the KEYTRUDA plus LENVIMA arm, the most common TEAEs of any grade occurring in at least 25% of patients were hypertension (64.0%), hypothyroidism (57.4%), diarrhea (54.2%), nausea (49.5%), decreased appetite (44.8%), vomiting (36.7%), weight decrease (34.0%), fatigue (33.0%), arthralgia (30.5%), proteinuria (28.8%), anemia (26.1%), constipation (25.9%) and urinary tract infection (25.6%). In the TPC arm, the most common TEAEs of any grade occurring in at least 25% of patients were anemia (48.7%), nausea (46.1%), neutropenia (33.8%), alopecia (30.9%), and fatigue (27.6%). Median treatment duration was 231 days (range: 1-817) with KEYTRUDA plus LENVIMA and 104.5 days (range: 1-785) with TPC.
KEYNOTE-775/Study 309 is the confirmatory trial for KEYNOTE-146/Study 111, which supported the U.S. Food and Drug Administration’s (FDA) 2019 accelerated approval of the KEYTRUDA plus LENVIMA combination for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation.
KEYNOTE-775/Study 309 Trial Design (Plenary Session #10191)
KEYNOTE-775/Study 309 is a multicenter, randomized, open-label, Phase 3 trial (ClinicalTrials.gov, NCT03517449) evaluating KEYTRUDA in combination with LENVIMA in patients with advanced endometrial cancer following one prior platinum-based regimen in any setting. The dual primary endpoints are PFS, as assessed by BICR per RECIST v1.1, and OS. Select secondary endpoints include ORR, as assessed by BICR per RECIST v1.1, and safety/tolerability. Of the 827 patients enrolled, 697 patients had tumors that were pMMR, and 130 patients had tumors that were dMMR. Patients were randomized 1:1 to receive:
- KEYTRUDA (200 mg intravenously [IV] every three weeks for up to 35 cycles [approximately two years]) in combination with LENVIMA (20 mg orally once daily); or
- Chemotherapy treatment of physician’s choice (TPC) of either doxorubicin (60 mg/m2 IV every three weeks for up to a maximum cumulative dose of 500 mg/m2) or paclitaxel (80 mg/m2 IV on a 28-day cycle [three weeks of receiving weekly paclitaxel and one week of not receiving paclitaxel]).
About KEYTRUDA® (pembrolizumab) Injection, 100 mg
KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,400 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.
How KEYTRUDA + LENVIMA may help
KEYTRUDA and LENVIMA are prescribed in combination to help treat your advanced endometrial cancer. Learn more about your treatment.
https://www.keytrudalenvima.com/advanced-endometrial-cancer/
Please see Prescribing Information for KEYTRUDA (pembrolizumab) at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf and Medication Guide for KEYTRUDA at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf.
About LENVIMA® (lenvatinib) Capsules
LENVIMA® (lenvatinib) is a kinase inhibitor that is indicated:
- For the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-refractory DTC)
- In combination with everolimus, for the treatment of patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy
- For the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC)
- In combination with KEYTRUDA, for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy, and are not candidates for curative surgery or radiation. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial
LENVIMA, discovered and developed by Eisai, is a kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. In syngeneic mouse tumor models, lenvatinib decreased tumor-associated macrophages, increased activated cytotoxic T cells, and demonstrated greater antitumor activity in combination with an anti-PD-1 monoclonal antibody compared to either treatment alone.
What is LENVIMA?
LENVIMA is a prescription medicine that is used to treat certain kinds of cancer.
- LENVIMA is used by itself to treat differentiated thyroid cancer (DTC), a type of thyroid cancer that can no longer be treated with radioactive iodine and is progressing
- LENVIMA is used along with another medicine called everolimus to treat advanced renal cell carcinoma (RCC), a type of kidney cancer, after one course of treatment with another anti-cancer medicine
- LENVIMA is used by itself as the first treatment for a type of liver cancer called hepatocellular carcinoma (HCC) when it cannot be removed by surgery
It is not known if LENVIMA is safe and effective in children.
Please see Prescribing Information for LENVIMA (lenvatinib) at http://www.lenvima.com/pdfs/prescribing-information.pdf.
About the Merck and Eisai Strategic Collaboration
In March 2018, Eisai and Merck, known as MSD outside the United States and Canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA. Under the agreement, the companies will jointly develop, manufacture and commercialize LENVIMA, both as monotherapy and in combination with Merck’s anti-PD-1 therapy KEYTRUDA.
In addition to ongoing clinical studies evaluating the KEYTRUDA plus LENVIMA combination across several different tumor types, the companies have jointly initiated new clinical studies through the LEAP (LEnvatinib And Pembrolizumab) clinical program and are evaluating the combination in 14 different tumor types (endometrial carcinoma, hepatocellular carcinoma, melanoma, non-small cell lung cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck, urothelial cancer, biliary tract cancer, colorectal cancer, gastric cancer, glioblastoma, ovarian cancer, pancreatic cancer and triple-negative breast cancer) across more than 20 clinical trials.
For more information, visit www.merck.com
For more information about Eisai, please visit www.eisai.com (for global), us.eisai.com (for U.S.) or www.eisai.eu (for Europe, Middle East, Africa),
Merck's Keytruda combo shines in late-stage endometrial cancer study
Mar. 19, 2021 7:06 AM ET Merck & Co., Inc. (MRK) By: Aakash Babu, SA News Editor
- Merck (NYSE:MRK) announces that it's late-stage study testing the combination of its blockbuster cancer drug Keytruda with tyrosine kinase inhibitor LENVIMA in certain patients with endometrial cancer, met the main goals.
https://seekingalpha.com/symbol/MRK
https://us.eisai.com/who-we-are/collaboration
PONVORY™ (ponesimod)
Janssen Announces U.S. FDA Approval of PONVORY™ (ponesimod), an Oral Treatment for Adults with Relapsing Multiple Sclerosis Proven Superior to Aubagio® (teriflunomide) in Reducing Annual Relapses and Brain LesionsHead-to-head pivotal clinical trial results showed PONVORY™ treatment led to nearly a third fewer annual relapses than teriflunomide
PONVORY™ is the first and only FDA-approved oral disease modifying therapy studied against an established oral comparator
Approval follows more than 10 years of cumulative data demonstrating the treatment’s efficacy and safety
TITUSVILLE, N.J. – (March 19, 2021) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) approved PONVORY™ (ponesimod), a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.1,2,3 PONVORY™ offers MS patients superior efficacy in reducing annualized relapse rates compared to an established oral therapy and a proven safety profile backed by over a decade of cumulative clinical research.3,4,5
PONVORY™ also prevented disability from worsening for most people. Nine in 10 PONVORY™-treated patients did not have worsening of 3-month disability, and PONVORY™ showed a numerical benefit in delaying disability progression. The difference in rates of disability progression was not statistically significant between the PONVORY™ and teriflunomide groups.3
About the Phase 3 Study8
The Oral Ponesimod Versus Teriflunomide In Relapsing Multiple Sclerosis (OPTIMUM) trial was a head-to-head, prospective, multicenter, randomized, double-blind Phase 3 study comparing efficacy, safety and tolerability of PONVORY™ 20 mg versus teriflunomide 14 mg in adults with relapsing MS. The primary endpoint of the study, which included 1,133 participants, was the annualized relapse rate (ARR) from baseline through the study period. The study included several other important efficacy endpoints, including the number of new Gd-enhancing T1 lesions from baseline to Week 108, the number of new or enlarging T2 lesions from baseline to Week 108, and the time to 3-month and 6-month confirmed disability progression.
PONVORY™ (ponesimod)
About PONVORY™
PONVORY™ (ponesimod) is a daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, indicated to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.1,2,3 PONVORY™ is believed to work by keeping immune cells called lymphocytes out of the blood by trapping them in the lymph nodes.3 The way PONVORY™ exerts therapeutic effects in MS is unknown, but may help keep the lymphocytes out of the central nervous system, where they could cause damage.3
PONVORY™ does not require genetic testing or first-dose cardiac monitoring for most patients. Because initiation of PONVORY™ treatment results in a decrease in heart rate, first-dose monitoring is recommended in patients with certain preexisting cardiac conditions.3
It is not known if PONVORY™ is safe and effective in children.
Janssen submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ponesimod for treatment of adults with relapsing multiple sclerosis in Q1 2020, which is currently under review.
A member of the Janssen Pharmaceutical Companies of Johnson & Johnson, Actelion Pharmaceuticals Ltd is party to a revenue sharing agreement with Idorsia Pharmaceuticals Ltd, which provides for certain payments to Idorsia related to the sales of ponesimod.
Please see full Prescribing Information and Medication Guide.
Learn more at www.janssen.com.
FDA approves Johnson & Johnson's multiple sclerosis drug ponesimod
Mar. 19, 2021 8:35 AM ET
By: Jonathan M Block, SA News Editor1 Comment
- The FDA has approved Johnson & Johnson's (NYSE:JNJ) oral therapy Ponvory (ponesimod) for relapsing multiple sclerosis.
https://seekingalpha.com/symbol/JNJ
Mavacamten
U.S. Food and Drug Administration (FDA) Accepts Bristol Myers Squibb’s Application for Mavacamten in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
03/19/2021CATEGORY:
U.S. FDA has assigned a target action date of January 28, 2022
Application based on results from the Phase 3 EXPLORER-HCM trial
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for mavacamten, an investigational, novel, oral, allosteric modulator of cardiac myosin, for patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of January 28, 2022.
Mavacamten
Mavacamten is an investigational therapy that is not approved for use in any country.
About Mavacamten
Mavacamten is a first-in-class, oral, allosteric modulator of cardiac myosin, under investigation for the treatment of conditions in which excessive cardiac contractility and impaired diastolic filling of the heart are the underlying cause. Mavacamten is thought to work by reducing cardiac muscle contractility by inhibiting excessive myosin-actin cross-bridge formation that results in hypercontractility, left ventricular hypertrophy and reduced compliance. In clinical and preclinical studies, mavacamten has consistently reduced biomarkers of cardiac wall stress, lessened excessive cardiac contractility, and increased diastolic compliance.
About EXPLORER-HCM
The EXPLORER-HCM Phase 3 trial enrolled a total of 251 patients with symptomatic (NYHA Class II or III), obstructive hypertrophic cardiomyopathy. All participants had measurable left ventricular outflow tract (LVOT) gradient (resting and/or provoked) ≥50 mmHg at baseline.
The primary endpoint for EXPLORER-HCM was a composite functional analysis designed to capture mavacamten’s effect on both symptoms and function. Secondary endpoints were changes from baseline to week 30 in postexercise LVOT gradient, pVO2, proportion of patients with at least one NYHA class improvement, and measures of patientreported outcomes. Additional endpoints included changes from baseline to Week 30 in echocardiographic indices, circulating biomarkers, cardiac rhythm patterns and accelerometry.
For more information about Bristol Myers Squibb, visit us at BMS.com
FDA accepts Bristol Myers Squibb's mavacamten NDA for review
Mar. 19, 2021 7:23 AM ET
Bristol-Myers Squibb Company (BMY)
By: Aakash Babu, SA News Editor
- Bristol Myers Squibb (NYSE:BMY) announces that the U.S. FDA has accepted its New Drug Application (NDA) for mavacamten, an investigational, novel, oral, allosteric modulator of cardiac myosin, for patients with symptomatic obstructive hypertrophic cardiomyopathy ((oHCM)), with an action date of January 28, 2022.
https://seekingalpha.com/news/3674352-fda-accepts-bristol-myers-squibbs-mavacamten-nda-for-review
https://seekingalpha.com/symbol/BMY