Moorestown, New Jersey, United States
BIOTECNOVA™
BIOTECNOVA™
BIOTECNOVA™ -First Group Page
BIOTECNOVA™
BiotecNOVA™ Running To The Light
BiotecNOVA™ Running To The Light
Nov. 15, 2020 7:57 AM ET| About: Amgen Inc. (AMGN), AZN, BMY, BNTX, GSK, JNJ, LLY, MRK, MRNA, NVS, PFE, RHHBY, SNY
Summary
“When you get on a plane everyone routes for the pilot”.
Pfizer (PFE) and Lilly (LLY) remain two of my top holdings.
Unfortunately for the state of Georgia, they will be subjected to countless new political ads for those competing for the two GA Senate races that will determine which party controls.
There have been many positive news articles on successful meds directed to cancer and other ailments just within the past 3 weeks.
biotecNOVA™ - Let The Light In
biotecNOVA™ - Let The Light In
Jul. 11, 2020 12:00 PM ET|About: Amgen Inc. (AMGN), BGNE, GILD, GSK, NVAX, PFE, AZN, JNJ
Summary
some encouraging biotech news events and hopeful USA investments in vaccine development and anti-viral development.
The number of Covid-19 cases in the USA is the highest in the world and getting worse.
a temporary truce between politicos and the biopharma community.
if there is a business sector that can unite Americans, Europeans and Chinese more than any other sector it is the biotech sector.
biotecNOVA™ January 2021/December 2020 insight
CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab)
CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab)
CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab)
CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab)
CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab)
Exelixis Announces U.S. FDA Approval of CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) as a First-Line Treatment for Patients with Advanced Renal Cell Carcinoma PDF Version
– FDA approval based on CheckMate -9ER trial, in which the combination of CABOMETYX and OPDIVO significantly improved overall survival while doubling progression-free survival and objective response rate versus sunitinib as a first-line treatment for patients with advanced RCC –
– Exelixis prepared to fully support expanded indication immediately –
– Application approved prior to Prescription Drug User Fee Act action date of February 20, 2021 and reviewed under the Real-Time Oncology Review pilot program –
ALAMEDA, Calif.--(BUSINESS WIRE)--Jan. 22, 2021-- Exelixis, Inc. (NASDAQ: EXEL) today announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX® (cabozantinib) for patients with advanced renal cell carcinoma (RCC) as a first-line treatment in combination with OPDIVO® (nivolumab). RCC is the most common form of kidney cancer, which is among the 10 most frequently diagnosed cancers in the U.S. annually.1
CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab)
Press Release
Exelixis Announces U.S. FDA Approval of CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) as a First-Line Treatment for Patients with Advanced Renal Cell Carcinoma PDF Version
– FDA approval based on CheckMate -9ER trial, in which the combination of CABOMETYX and OPDIVO significantly improved overall survival while doubling progression-free survival and objective response rate versus sunitinib as a first-line treatment for patients with advanced RCC –
– Exelixis prepared to fully support expanded indication immediately –
– Application approved prior to Prescription Drug User Fee Act action date of February 20, 2021 and reviewed under the Real-Time Oncology Review pilot program –
ALAMEDA, Calif.--(BUSINESS WIRE)--Jan. 22, 2021-- Exelixis, Inc. (NASDAQ: EXEL) today announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX® (cabozantinib) for patients with advanced renal cell carcinoma (RCC) as a first-line treatment in combination with OPDIVO® (nivolumab). RCC is the most common form of kidney cancer, which is among the 10 most frequently diagnosed cancers in the U.S. annually.1
“This combination of cabozantinib and nivolumab significantly improved key efficacy measures compared to sunitinib – progression-free survival, overall survival and objective response rate – while showing a low rate of treatment discontinuations due to side effects. The therapeutic benefit demonstrated in CheckMate -9ER and quality of life measures explored emphasize the role of this combination for patients with advanced kidney cancer,” said Dr. Toni Choueiri, Director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute and the Jerome and Nancy Kohlberg Professor of Medicine at Harvard Medical School. “With this important FDA approval, the combination is poised to become a standard in newly diagnosed metastatic kidney cancer.”
The approval is based on results from CheckMate -9ER, a phase 3 pivotal trial evaluating the combination of CABOMETYX and OPDIVO compared with sunitinib in previously untreated advanced or metastatic RCC. These results were presented during the European Society of Medical Oncology Virtual Congress 2020 in September. The FDA reviewed the application for CABOMETYX and OPDIVO under the Real-Time Oncology Review (RTOR) pilot program and Fast Track designation. The RTOR pilot program, which allows an applicant to pre-submit components of the application to allow the FDA to review clinical trial data before the complete filing is submitted, aims to explore a more efficient review process to ensure safe and effective treatments are available to patients sooner.
“As the only combination treatment regimen to double median progression-free survival and objective response rate compared with sunitinib while also significantly improving overall survival, we are excited that CABOMETYX in combination with OPDIVO is now available for the first-line treatment of patients with advanced kidney cancer,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. “This approval is a meaningful milestone for this patient community and speaks to the broad potential of CABOMETYX as we continue to generate important clinical trial results supporting its use in combination with immune checkpoint inhibitors to benefit patients with other difficult-to-treat cancers. We would like to thank the clinical trial participants, the physicians and their staff who participated in the CheckMate -9ER trial and to acknowledge the team at the FDA for their collaboration during the review of our application.”
In CheckMate -9ER, the combination regimen significantly improved overall survival (OS) compared with sunitinib (HR= 0.60, 98.89% CI 0.40-0.89; p=0.001). Median OS has not yet been reached in either treatment arm. Median progression-free survival (PFS) was doubled at 16.6 months for CABOMETYX in combination with OPDIVO compared with 8.3 months for sunitinib (HR 0.51, 95% CI 0.41-0.64; p<0.0001). Objective response rate (ORR) was also doubled: 56% with CABOMETYX in combination with OPDIVO and 27% with sunitinib (p<0.0001). Consistent results for PFS were observed across subgroups of International Metastatic RCC Database Consortium risk status and PD-L1 tumor expression with CABOMETYX in combination with OPDIVO.
CABOMETYX in combination with OPDIVO was generally well tolerated and reflected the known safety profiles of the tyrosine kinase inhibitor and immunotherapy components in previously untreated advanced RCC. The most common adverse reactions reported in at least 20% of patients treated with CABOMETYX in combination with OPDIVO were diarrhea, fatigue, hepatotoxicity, palmar-plantar erythrodysesthesia, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, dysgeusia, abdominal pain, cough and upper respiratory tract infection. The discontinuation rate due to all causality adverse events in the CABOMETYX in combination with OPDIVO arm was 20% for either CABOMETYX or OPDIVO (8% for CABOMETYX only, 7% for OPDIVO only and 6% for both CABOMETYX and OPDIVO due to the same adverse event at the same time).
About CABOMETYX® (cabozantinib)
In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced RCC; for the treatment of patients with HCC who have been previously treated with sorafenib; and for patients with advanced RCC as a first-line treatment in combination with OPDIVO (nivolumab). CABOMETYX tablets have also received regulatory approvals in the European Union and additional countries and regions worldwide. In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan. In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan. Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the United States.
Please see accompanying full Prescribing Information https://cabometyx.com/downloads/CABOMETYXUSPI.pdf.
For more information about Exelixis, please visit www.exelixis.com
Exelixis Announces U.S. FDA Approval of CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) as a First-Line Treatment for Patients with Advanced Renal Cell Carcinoma
Fri January 22, 2021 1:10 PM| Business Wire|About: EXEL
– FDA approval based on CheckMate -9ER trial, in which the combination of CABOMETYX and OPDIVO significantly improved overall survival while doubling progression-free survival and objective response rate versus sunitinib as a first-line treatment for patients with advanced RCC –
– Exelixis (EXEL) prepared to fully support expanded indication immediately –
– Application approved prior to Prescription Drug User Fee Act action date of February 20, 2021 and reviewed under the Real-Time Oncology Review pilot program –
ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (NASDAQ: EXEL)
Exelixis' CABOMETYX-OPDIVO combo wins FDA approval for renal cell carcinoma
Jan. 22, 2021 1:25 PM ET Exelixis, Inc. (EXEL)
By: Aakash Babu, SA News Editor9 Comments
- Exelixis (EXEL +2.6%) announces that the FDA has approved its CABOMETYX (cabozantinib) drug in combination with Bristol-Myers Squibb's (BMY +1.2%) OPDIVO (nivolumab) for treating patients with advanced renal cell carcinoma (RCC) in the first-line setting.
Opdivo® (nivolumab)
CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab)
XALKORI® (CRIZOTINIB)
U.S. Food and Drug Administration Accepts for Priority Review Application for Opdivo® (nivolumab) Combined with Chemotherapy as First-Line Treatment in Metastatic Gastric Cancer, Gastroesophageal Junction Cancer and Esophageal Adenocarcinoma
01/20/2021CATEGORY:
U.S. Food and Drug Administration assigned a target action date of May 25, 2021PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer (GEJC) or esophageal adenocarcinoma (EAC), based on results from the CheckMate -649 trial. The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 25, 2021.
Opdivo® (nivolumab) Combined with Chemotherapy
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.
INDICATIONSOPDIVO® (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) is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy. 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 first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC).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.https://www.opdivo.com/
U.S. Food and Drug Administration Accepts for Priority Review Application for Opdivo® (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer
Wed January 20, 2021 6:59 AM|Business Wire|About: BMY U.S. Food and Drug Administration assigned a target action date of May 20, 2021Application based on Phase 3 CheckMate -577 trial, in which Opdivo doubled median disease-free survival versus placebo in patients with esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy and surgeryOpdivo demonstrated a manageable safety profile consistent with prior studies
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)
XALKORI® (CRIZOTINIB)
CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab)
XALKORI® (CRIZOTINIB)
PFIZER’S XALKORI® (CRIZOTINIB) APPROVED BY FDA FOR ALK-POSITIVE ANAPLASTIC LARGE CELL LYMPHOMA IN CHILDREN AND YOUNG ADULTS
Thursday, January 14, 2021 - 04:30pm
XALKORI is the first biomarker-driven therapy for relapsed or refractory ALCL in young people
NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for XALKORI® (crizotinib) for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive. The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. ALCL is a rare form of non-Hodgkin lymphoma (NHL) and accounts for approximately 30% of cases of NHL in young people.1,2,3 Approximately 90% of ALCL cases in young people are ALK-positive.4,5,6
XALKORI® (CRIZOTINIB)
About XALKORI® (crizotinib)
XALKORI is a tyrosine kinase inhibitor (TKI) indicated for the treatment of patients with metastatic NSCLC whose tumors are ALK- or ROS1-positive as detected by an FDA-approved test. In addition to the United States, XALKORI has received approval for patients with ALK-positive NSCLC in more than 90 countries including Australia, Canada, China, Japan, South Korea and the European Union. XALKORI is also approved for ROS1-positive NSCLC in more than 70 countries.
XALKORI is indicated for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.
The full prescribing information for XALKORI can be found here.
IMPORTANT XALKORI® (crizotinib) 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/20210114006005/en/
Pfizer’s XALKORI® (crizotinib) Approved by FDA for ALK-positive Anaplastic Large Cell Lymphoma in Children and Young Adults
Thu January 14, 2021 4:30 PM| Business Wire|About: PFE
XALKORI is the first biomarker-driven therapy for relapsed or refractory ALCL in young people
NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE)
Pfizer’s XALKORI wins FDA's expanded approval for a form of lymphoma
Jan. 14, 2021 4:44 PM ET Pfizer Inc. (PFE)By: Aakash Babu, SA News Editor3 Comments
- The FDA has approved Pfizer's (NYSE:PFE) supplemental New Drug Application ((sNDA)) for XALKORI (crizotinib) for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase positive.
https://seekingalpha.com/symbol/PFE
XALKORI® (CRIZOTINIB)
Indications
XALKORI is a prescription medicine used to treat people with non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by a defect in either a gene called ALK (anaplastic lymphoma kinase) or a gene called ROS1. It is not known if XALKORI is safe and effective in children.
IMFINZI® (durvalumab
Jardiance® (empagliflozin)
IMBRUVICA® (ibrutinib)
Imfinzi (durvalumab)
15 January 2021 07:00 GMT
Imfinzi approved in the EU for less-frequent, fixed-
dose use in unresectable non-small cell lung cancer
New option extends dosing from two to four weeks,
reducing medical visits and improving patient convenience
AstraZeneca's Imfinzi (durvalumab) has been approved in the European Union and the UK for an additional dosing option, a 1,500mg fixed dose every four weeks, in locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on at least 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy (CRT).
AstraZeneca’s Imfinzi additional dosing option OK'd in the EU/UK
Jan. 15, 2021 7:27 AM ET AstraZeneca PLC (AZN) By: Vandana Singh, SA News Editor
- AstraZeneca's (NASDAQ:AZN) Imfinzi (durvalumab) has been approved in the EU and the U.K. for an additional dosing option. New dosing is a 1,500mg fixed dose every four weeks, in locally advanced, unresectable non-small cell lung cancer in adults whose tumors express PD-L1 on at least 1% of tumor cells and whose disease has not progressed following platinum-based chemoradiation therapy.
https://seekingalpha.com/news/3651756-astrazeneca-s-imfinzi-additional-dosing-option-okd-in-eu-uk
https://seekingalpha.com/symbol/AZN
Imfinzi (durvalumab)
IMFINZI® (durvalumab) is a prescription medicine used to treat adults with a type of cancer in the bladder and urinary tract called urothelial carcinoma. IMFINZI may be used when your urothelial carcinoma has spread or cannot be removed by surgery, and chemotherapy containing platinum did not work or is no longer working. IMFINZI was FDA approved for this use based on a clinical study that measured how many patients responded and how long they responded. The study is ongoing to confirm clinical benefit.
IMFINZI is a prescription medicine used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC). IMFINZI may be used when your NSCLC has not spread outside your chest, cannot be removed by surgery, and has responded or stabilized with initial treatment with chemotherapy that contains platinum, given at the same time as radiation therapy.
IMFINZI is a prescription medicine used to treat adults with a type of lung cancer called small cell lung cancer (SCLC). IMFINZI may be used with the chemotherapy medicines etoposide and carboplatin or cisplatin as your first treatment when your SCLC has spread within your lungs or to other parts of the body (extensive-stage small cell lung cancer, or ES-SCLC).
It is not known if IMFINZI is safe and effective in children.
. Please visit astrazeneca.com
IMBRUVICA® (ibrutinib)
Jardiance® (empagliflozin)
IMBRUVICA® (ibrutinib)
Health Canada Approves IMBRUVICA®* (ibrutinib) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia (CLL)
Wed January 13, 2021 7:30 AM| Canada Newswire| About: JNJ Patients aged 70 or younger with previously untreated CLL lived longer without disease progression compared to patients treated with FCR, a chemoimmunotherapy regimen TORONTO, Jan. 13, 2021 /CNW/ - The Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ) announced today that Health Canada has approved IMBRUVICA® (ibrutinib) in combination with rituximab for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).i Today's milestone marks the tenth Health Canada approval for IMBRUVICA® across five disease areas and is the fifth approval for IMBRUVICA® in CLL.ii
IMBRUVICA®* (ibrutinib)
About IMBRUVICA® IMBRUVICA® contains the medicinal ingredient ibrutinib which is a targeted inhibitor of Bruton's tyrosine kinase (BTK), and it is the only once-daily BTK inhibitor in Canada. Ibrutinib blocks BTK activity, inhibiting cancer cell survival and spread.xvIMBRUVICA® was first approved in Canada in 2014. It is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL),xvi including those with 17p deletion; or adult patients with CLL who have received at least one prior therapy, including those with 17p deletion.xvii It is indicated in combination with bendamustine and rituximab for the treatment of adult patients with CLL who have received at least one prior therapy, and in combination with obinutuzumab for treatment-naïve adult patients with CLL.xviii It is now also indicated in combination with rituximab for the treatment of adult patients with previously untreated CLL.xixFor adult patients with Waldenström's macroglobulinemia (WM), IMBRUVICA® is indicated as a single agent or in combination with rituximab.xx Other indications are for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL); patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy; and for patients with steroid dependent or refractory chronic graft-versus-host disease (cGVHD).xxiIMBRUVICA® is co-developed by Cilag GmbH International (a member of the Janssen Pharmaceutical Companies) and Pharmacyclics LLC, an AbbVie company. Janssen Inc. commercializes IMBRUVICA® in Canada.https://imbruvica.com/
Learn more at www.janssen.com/canada.
Johnson & Johnson's Imbruvica combo OK'd in Canada in CLL setting
Jan. 13, 2021 8:25 AM ET Johnson & Johnson (JNJ) By: Aakash Babu, SA News Editor
- Health Canada has approved Johnson & Johnson's (NYSE:JNJ)
https://seekingalpha.com/news/3651021-johnson-johnsons-imbruvica-combo-okd-in-canada-in-cll-setting
https://www.janssen.com/canada/
https://seekingalpha.com/symbol/JNJ
Jardiance® (empagliflozin)
Jardiance® (empagliflozin)
Jardiance® (empagliflozin)
US FDA accepts supplemental New Drug Application for Jardiance® (empagliflozin) for adults with heart failure with reduced ejection fraction
January 11, 2021Download PDFRIDGEFIELD, Conn. and INDIANAPOLIS, Jan. 11, 2021 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Jardiance® (empagliflozin) which is being investigated as a potential new treatment to reduce the risk of cardiovascular death and hospitalization for heart failure and to slow kidney function decline in adults with chronic heart failure with reduced ejection fraction, including those with and without type 2 diabetes, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced.
- EMPEROR-Reduced [NCT03057977] investigated the safety and efficacy of Jardiance in patients with chronic heart failure with reduced ejection fraction (HFrEF).
- Primary composite endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure
- Number of patients: 3,730
- Completion: 2020
- EMPEROR-Preserved [NCT03057951] investigates the safety and efficacy of Jardiance in patients with chronic heart failure with preserved ejection fraction (HFpEF).
- Primary composite endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure [Time Frame: up to 38 months]
- Anticipated number of patients: approx. 5,990
- Estimated completion: 2021
Jardiance® (empagliflozin) What is JARDIANCE? (www.jardiance.com) JARDIANCE is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.JARDIANCE is also used to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease. JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
For more information, please see Prescribing Information and Medication Guide.
For more information, please visit www.boehringer-ingelheim.us
About Lilly Diabetes Lilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research, collaboration and quality manufacturing we strive to make life better for people affected by diabetes and related conditions. We work to deliver breakthrough outcomes through innovative solutions—from medicines and technologies to support programs and more. For the latest updates, visit http://www.lillydiabetes.com/ or follow us on Twitter: @LillyDiabetes and Facebook: LillyDiabetesUS.
Jardiance® and EMPA-REG OUTCOME® are registered trademarks of Boehringer Ingelheim.
https://www.jardiance.com/
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https://seekingalpha.com/symbol/LLY
FARXIGA® (dapagliflozin)
FARXIGA® (dapagliflozin)
Jardiance® (empagliflozin)
FARXIGA® (dapagliflozin)
FARXIGA granted Priority Review in the US for the treatment of patients with chronic kidney disease
PUBLISHED6 January 2021
FARXIGA could become the first SGLT2 inhibitor approved to treat
patients with chronic kidney disease, with and without type 2 diabetes
AstraZeneca’s FARXIGA (dapagliflozin) has been granted Priority Review in the US for the treatment of new or worsening chronic kidney disease (CKD) in adults with and without type 2 diabetes (T2D).
In March 2020, an independent Data Monitoring Committee recommended the trial be stopped early, based on its determination of overwhelming efficacy. Detailed results from the DAPA-CKD trial were shared in August 2020 and published in The New England Journal of Medicine.
FARXIGA® (dapagliflozin)
Please see accompanying US Full Prescribing Information and Medication Guide for FARXIGA.
What is FARXIGA?
FARXIGA is a prescription medicine used to:
improve blood sugar control along with diet and exercise in adults with type 2 diabetes
reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and known cardiovascular disease or multiple cardiovascular risk factors
reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (when the heart is weak and cannot pump enough blood to the rest of your body)
FARXIGA should not be used to treat people with type 1 diabetes or diabetic ketoacidosis (increased ketones in your blood or urine).
For more information, please visit www.astrazeneca-us.com
FARXIGA Granted Priority Review in the US for the Treatment of Patients With Chronic Kidney Disease
Wed January 6, 2021 7:00 AM |Business Wire| About: AZN
FARXIGA could become the first SGLT2 inhibitor approved to treat patients with chronic kidney disease, with and without type 2 diabetes
WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca’s FARXIGA (dapagliflozin) has been granted Priority Review in the US for the treatment of new or worsening chronic kidney disease (CKD) in adults with and without type 2 diabetes (T2D).
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AstraZeneca’s Farxiga nabs U.S.
Priority Review for CKD
Jan. 06, 2021 9:15 AM ET AstraZeneca PLC (AZN) By: Vandana Singh, SA News Editor
https://seekingalpha.com/news/3649261-astrazeneca-s-farxiga-nabs-u-s-priority-review-for-ckd
Lynparza (olaparib)
FARXIGA® (dapagliflozin)
IMBRUVICA® (ibrutinib)
Lynparza (olaparib)
Lynparza approved in Japan for the treatment of advanced ovarian, prostate and pancreatic cancers
PUBLISHED28 December 2020
28 December 2020 07:00 GMT
Approvals based on the PAOLA-1, PROfound and POLO Phase III trials
AstraZeneca and MSD’s Lynparza (olaparib) has been approved in Japan for the treatment of advanced ovarian, prostate and pancreatic cancers.
Lynparza (olaparib)
WHAT IS LYNPARZA?
LYNPARZA is a prescription medicine used to treat adults who have:
- advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene. LYNPARZA is used alone as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
- advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of abnormal BRCA gene or a positive laboratory tumor test for genomic instability called HRD. LYNPARZA is used in combination with another anti-cancer medicine, bevacizumab, as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
- ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, as maintenance treatment, when the cancer has come back. LYNPARZA is used after the cancer has responded to treatment with platinum-based chemotherapy
- advanced ovarian cancer with a certain type of abnormal inherited BRCA gene, and have received treatment with 3 or more prior types of chemotherapy medicines. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
- a certain type of abnormal inherited BRCA gene, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic). You should have received chemotherapy medicines, either before or after your cancer has spread. If you have hormone receptor (HR)-positive disease, you should have been treated with hormonal therapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
- metastatic pancreatic cancer with a certain type of abnormal inherited BRCA gene. LYNPARZA is used as a maintenance treatment after your cancer has not progressed on at least 16 weeks of treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure LYNPARZA is right for you
- prostate cancer with certain inherited or acquired abnormal genes called homologous recombination repair (HRR genes). LYNPARZA is used when the cancer has spread to other parts of the body (metastatic), and no longer responds to a medical or surgical treatment that lowers testosterone, and has progressed after treatment with enzalutamide or abiraterone. Your healthcare provider will perform a test to make sure LYNPARZA is right for you
It is not known if LYNPARZA is safe and effective in children.
Lynparza
Lynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumours harbouring a deficiency in HRR, such as mutations in BRCA1 and/or BRCA2. Inhibition of PARP with Lynparza leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death. Lynparza is being tested in a range of PARP-dependent tumour types with defects and dependencies in the DDR pathway.
The concurrent approvals by the Japanese Ministry of Health, Labour, and Welfare are based on positive results from the PAOLA-1, PROfound and POLO Phase III trials, which each were published in The New England Journal of Medicine.
The AstraZeneca and MSD strategic oncology collaboration
In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the US and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialise Lynparza, the world’s first PARP inhibitor, and Koselugo (selumetinib), a mitogen-activated protein kinase (MEK) inhibitor, for multiple cancer types. Working together, the companies will develop Lynparza and Koselugo in combination with other potential new medicines and as monotherapies. Independently, the companies will develop Lynparza and Koselugo in combination with their respective PD-L1 and PD-1 medicines.
Please visit astrazeneca.com
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AstraZeneca, Merck’s Lynparza OK'd in Japan for cancers
Dec. 28, 2020 7:16 AM ETAstraZeneca PLC (AZN)By: Mamta Mayani, SA News Editor
https://seekingalpha.com/news/3647466-astrazeneca-merck-s-lynparza-okd-in-japan-for-cancers
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IMBRUVICA® (ibrutinib)
FARXIGA® (dapagliflozin)
IMBRUVICA® (ibrutinib)
IMBRUVICA® (ibrutinib)
December 23, 2020
IMBRUVICA® (ibrutinib) U.S. Prescribing Information Updated to Include Long-Term Data for Waldenström's Macroglobulinemia (WM)
- Updates are based on more than five years of Phase 3 iNNOVATE final analysis data, which demonstrated IMBRUVICA plus rituximab significantly prolonged progression-free survival (PFS) versus rituximab alone in adults with WM
- IMBRUVICA is the first and only FDA-approved treatment for adults with WM and has been used to treat more than 200,000 patients worldwide across approved indications
NORTH CHICAGO, Ill., Dec. 23, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today that the U.S. Food and Drug Administration (FDA) approved the update of the IMBRUVICA® (ibrutinib) Prescribing Information to include efficacy and safety data for the combination of IMBRUVICA with rituximab for the treatment of Waldenström's macroglobulinemia (WM), based on the final analysis of the Phase 3 iNNOVATE study. First approved in 2013, IMBRUVICA is currently available to patients with several types of blood cancer, as well as chronic graft-versus-host disease. It was approved as a mo
IMBRUVICA® (ibrutinib)
About IMBRUVICA
IMBRUVICA is a once-daily, first-in-class BTK inhibitor that is administered orally, and is jointly developed and commercialized by Pharmacyclics, LLC, an AbbVie Company, and Janssen Biotech, Inc. (Janssen). The BTK protein sends important signals that tell B cells to mature and produce antibodies. BTK signaling is needed by specific cancer cells to multiply and spread.3,4 By blocking BTK, IMBRUVICA may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs.5
Since its launch in 2013, IMBRUVICA has received 11 FDA approvals across six disease areas: chronic lymphocytic leukemia (CLL) with or without 17p deletion (del17p); small lymphocytic lymphoma (SLL) with or without del17p; WM; previously-treated patients with mantle cell lymphoma (MCL)*; previously-treated patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy* – and previously-treated patients with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.6
IMBRUVICA is now approved in 101 countries and has been used to treat more than 200,000 patients worldwide across its approved indications. IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA has been granted four Breakthrough Therapy Designations from the U.S. FDA. This designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway.
As of early 2019, the National Comprehensive Cancer Network® (NCCN®), a not-for-profit alliance of 28 leading cancer centers devoted to patient care, research, and education, recommends ibrutinib (IMBRUVICA) as a preferred regimen for the initial treatment of CLL/SLL and is a Category 1 treatment for treatment-naïve patients without deletion 17p. In January 2020, the NCCN Guidelines® were updated to recommend IMBRUVICA, with or without rituximab, as a preferred regimen for the treatment of relapsed/refractory MCL, regardless of response duration to prior chemoimmunotherapy. In September 2020, the NCCN guidelines for WM were updated and now recommends IMBRUVICA, with or without rituximab, as the only Category 1 Preferred regimen for patients with previously untreated or previously treated WM.
IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. IMBRUVICA is the most comprehensively studied BTK inhibitor, with more than 150 ongoing clinical trials. There are approximately 30 ongoing company-sponsored trials, 14 of which are in Phase 3, and more than 100 investigator-sponsored trials and external collaborations that are active around the world. For more information, visit www.IMBRUVICA.com.
*Accelerated approval was granted for the MCL and MZL indications based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.
Please click here for full Prescribing Information.
For more information about AbbVie, please visit us at www.abbvie.com
AbbVie's Imbruvica wins expanded prescribing information approval from FDA
Dec. 23, 2020 8:44 AM ET AbbVie Inc. (ABBV) By: Aakash Babu, SA News Editor8 Comments
biotecNOVA™ November & October 2020 insight
KEYTRUDA® (pembrolizumab) Plus Chemotherapy
KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib)
KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib)
FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) Plus Chemotherapy as First-Line Treatment for Locally Advanced Unresectable or Metastatic Esophageal and Gastroesophageal Junction Cancer
December 17, 2020 6:45 am EST
Application Based on Overall Survival and Progression-Free Survival Data Comparing KEYTRUDA Plus Chemotherapy to Chemotherapy Alone From Pivotal Phase 3 KEYNOTE-590 Trial
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 accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum and fluoropyrimidine based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus and gastroesophageal junction (GEJ). This sBLA is based on data from the pivotal Phase 3 KEYNOTE-590 trial, in which KEYTRUDA plus chemotherapy demonstrated significant improvements in the primary endpoints – overall survival (OS) and progression-free survival (PFS) – versus chemotherapy in these patients regardless of PD-L1 expression status and tumor histology. These data were presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of April 13, 2021.
KEYTRUDA® (pembrolizumab) Plus 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 1,300 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.
Small Cell Lung Cancer
KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of 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 confirmatory trials.
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 recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.
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.
Selected Important Safety Information for KEYTRUDA
Severe and Fatal Immune-Mediated Adverse Reactions
KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment.
Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.
Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.
Immune-Mediated Pneumonitis
KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.
Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients, 42% of these patients interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.
Immune-Mediated Colitis
KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients.
Hepatotoxicity and Immune-Mediated Hepatitis
KEYTRUDA as a Single Agent
KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients.
KEYTRUDA with Axitinib
KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen, which was at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT ≥3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT ≥3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT ≥3 ULN subsequently recovered from the event.
A BREAKTHROUGH IMMUNOTHERAPY THAT MAY HELP YOU FACE YOUR CANCER
IT’S TRU. KEYTRUDA.
SELECT A TYPE OF CANCER
- Advanced non–small cell lung cancer
- Melanoma
- Head and neck squamous cell cancer
- High-risk non-muscle invasive bladder cancer (NMIBC)
- Advanced urothelial bladder cancer
- Advanced kidney cancer (RCC)
- Advanced MSI-H/dMMR colorectal cancer
- Microsatellite instability-high cancer (MSI-H/dMMR)
- Classical Hodgkin lymphoma (cHL)
- Advanced gastric cancer
- Advanced cervical cancer
- Primary mediastinal B‑cell lymphoma (PMBCL)
- Advanced liver cancer (HCC)
- Advanced Merkel cell carcinoma
- Advanced esophageal squamous cell carcinoma
- Cutaneous squamous cell carcinoma (cSCC)
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/20201217005083/en/
For more information, visit www.merck.com
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KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib)
KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib)
KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib)
KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Combination Demonstrated Statistically Significant Improvement in Overall Survival, Progression-Free Survival and Objective Response Rate Versus Chemotherapy in Patients With Advanced Endometrial Cancer Following Prior Systemic Therapy in Phase 3 Study
December 16, 2020 6:45 am ESTFirst Overall Survival Analysis for KEYTRUDA Plus LENVIMA Combination in a Phase 3 Study in Advanced Endometrial CancerKENILWORTH, N.J. & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced that the pivotal Phase 3 KEYNOTE-775/Study 309 trial evaluating the investigational use of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) and its secondary efficacy endpoint of objective response rate (ORR) in patients with advanced endometrial cancer following at least one prior platinum-based regimen.
KEYTRUDA® (pembrolizumab) Injection, 100 mg About KEYTRUDA® (pembrolizumab) Injection, 100 mgKEYTRUDA 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 1,300 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.MelanomaKEYTRUDA 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 CancerKEYTRUDA, 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.Small Cell Lung CancerKEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of 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 confirmatory trials.Head and Neck Squamous Cell CancerKEYTRUDA, 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 LymphomaKEYTRUDA 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 LymphomaKEYTRUDA 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 CarcinomaKEYTRUDA 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 CancerKEYTRUDA 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 CancerKEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).Gastric CancerKEYTRUDA 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 CancerKEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.Cervical CancerKEYTRUDA 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 CarcinomaKEYTRUDA 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 CarcinomaKEYTRUDA 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 CarcinomaKEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).Endometrial CarcinomaKEYTRUDA, in combination with LENVIMA, is indicated 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. 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.Tumor Mutational Burden-HighKEYTRUDA 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 CarcinomaKEYTRUDA 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 CancerKEYTRUDA, 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.Selected Important Safety Information for KEYTRUDASevere and Fatal Immune-Mediated Adverse ReactionsKEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment.Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.
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. https://www.keytruda.com/
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 (lenvatinib) is available as 10 mg and 4 mg capsules.
Please see Prescribing Information for LENVIMA (lenvatinib) at http://www.lenvima.com/pdfs/prescribing-information.pdf.
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)
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Merck/Eisai's Keytruda and Lenvima combo meet endpoints in late-stage uterine cancer study
Dec. 16, 2020 7:25 AM ETMerck & Co., Inc. (MRK)By: Vandana Singh, SA News Editor
- Merck (NYSE:MRK) and Eisai (OTCPK:ESALF) have announced data demonstrating positive top-line results from Phase 3 KEYNOTE-775/Study 309, evaluating Merck's Keytruda plus Eisai's Lenvima in patients with advanced endometrial cancer following at least one prior platinum-based regimen.
VENCLEXTA® (venetoclax)
KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib)
KEYTRUDA® (pembrolizumab) Injection, 100 mg
Health Canada Approves VENCLEXTA® (venetoclax) in combination with azacitidine or low dose cytarabine for untreated Acute Myeloid Leukemia (AML)
Tue December 15, 2020 7:30 AM|Canada Newswire|About: ABBV
- Health Canada's approval of VENCLEXTA for newly diagnosed AML patients who are ineligible for intensive chemotherapy is supported by data from two Phase 3 trials - VIALE-A (M15-656) and VIALE-C (M16-043)1.
- The VIALE-A trial demonstrated a statistically significant increase in overall survival with VENCLEXTA in combination with azacitidine compared to azacitidine alone.1
- In the VIALE-C trial, clinical benefit was based on rate and duration of complete response.1
- AML is one of the most difficult-to-treat blood cancers with a very low survival rate.2,3
MONTREAL, Dec. 15, 2020 /CNW/ - AbbVie (ABBV), a research-based global biopharmaceutical company, announced today that Health Canada has approved VENCLEXTA® (venetoclax) in combination with azacitidine or low-dose cytarabine (LDAC) for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy. AML is an aggressive and difficult-to-treat blood cancer with a low survival rate.2,3 In Canada, the five-year survival rate for patients diagnosed with AML is approximately 21%.3
VENCLEXTA® (venetoclax)
https://www.venclexta.com/
Uses
VENCLEXTA is a prescription medicine used:
- to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who:
- are 75 years of age or older, or
- have other medical conditions that prevent the use of standard chemotherapy.
VENCLEXTA was approved based on response rates. Continued approval for this use may depend on the results of an ongoing study to find out how VENCLEXTA works over a longer period of time.
It is not known if VENCLEXTA is safe and effective in children.
For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com.
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KEYTRUDA® (pembrolizumab) Injection, 100 mg
KEYTRUDA® (pembrolizumab) Injection, 100 mg
KEYTRUDA® (pembrolizumab) Injection, 100 mg
Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) as First-Line Treatment in Adult Patients With Metastatic Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer
December 11, 2020 7:10 am EST
Opinion Granted Based on Significant Progression-Free Survival Benefit Demonstrated With KEYTRUDA Monotherapy Compared to Standard-of-Care Chemotherapy in Pivotal Phase 3 KEYNOTE-177 Trial
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. This recommendation is based on results from the pivotal Phase 3 KEYNOTE-177 trial, in which KEYTRUDA, as a monotherapy, demonstrated a significant improvement in progression-free survival compared to chemotherapy (investigator’s choice: mFOLFOX6 with or without bevacizumab or cetuximab; or FOLFIRI with or without bevacizumab or cetuximab), a current standard of care.
KEYTRUDA® (pembrolizumab) Injection, 100 mg
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 1,300 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.
Small Cell Lung Cancer
KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of 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 confirmatory trials.
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 recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.
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.
A BREAKTHROUGH IMMUNOTHERAPY THAT MAY HELP YOU FACE YOUR CANCER
IT’S TRU. KEYTRUDA.
SELECT A TYPE OF CANCER
- Advanced non–small cell lung cancer
- Melanoma
- Head and neck squamous cell cancer
- High-risk non-muscle invasive bladder cancer (NMIBC)
- Advanced urothelial bladder cancer
- Advanced kidney cancer (RCC)
- Advanced MSI-H/dMMR colorectal cancer
- Microsatellite instability-high cancer (MSI-H/dMMR)
- Classical Hodgkin lymphoma (cHL)
- Advanced gastric cancer
- Advanced cervical cancer
- Primary mediastinal B‑cell lymphoma (PMBCL)
- Advanced liver cancer (HCC)
- Advanced Merkel cell carcinoma
- Advanced esophageal squamous cell carcinoma
- Cutaneous squamous cell carcinoma (cSCC)
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.
For more information, visit www.merck.com
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IMBRUVICA® (ibrutinib)
KEYTRUDA® (pembrolizumab) Injection, 100 mg
Calquence (acalabrutinib)
IMBRUVICA® (ibrutinib)
December 6, 2020
Combined Data from Multiple Phase 3 Studies of IMBRUVICA® (ibrutinib) Show Efficacy and Safety in High-Risk, Previously Untreated Chronic Lymphocytic Leukemia (CLL) and Real-World Data Indicating Low Biomarker Testing Rates for These Patients
NORTH CHICAGO, Ill., Dec. 6, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), today announced results from a long-term integrated analysis of two Phase 3 clinical studies and additional pooled analysis evaluating the effect of IMBRUVICA (ibrutinib) based therapies for the first-line treatment of high-risk patients with chronic lymphocytic leukemia (CLL). The totality of data featured at the virtual 2020 American Society of Hematology (ASH) Annual Meeting continues to establish the treatment benefit of IMBRUVICA for CLL patients with or without high-risk disease.
IMBRUVICA® (ibrutinib)
About IMBRUVICA
IMBRUVICA (ibrutinib) is an oral, once-daily medicine that works differently than chemotherapy as it blocks a protein called Bruton's tyrosine kinase (BTK). The BTK protein sends important signals that tell B cells to mature and produce antibodies. BTK signaling is needed by specific cancer cells to multiply and spread.6,7 By blocking BTK, IMBRUVICA may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs.8
Since its launch in 2013, IMBRUVICA has received 11 FDA approvals across six disease areas: chronic lymphocytic leukemia (CLL) with or without 17p deletion (del17p); small lymphocytic lymphoma (SLL) with or without del17p; Waldenström's macroglobulinemia (WM); previously-treated patients with mantle cell lymphoma (MCL)*; previously-treated patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy* – and previously-treated patients with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.9
IMBRUVICA is now approved in more than 100 countries and has been used to treat more than 200,000 patients worldwide across its approved indications. IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA has been granted four Breakthrough Therapy Designations from the U.S. FDA. This designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway
USES
What is IMBRUVICA® (ibrutinib)?
IMBRUVICA® (ibrutinib) is a prescription medicine used to treat adults with:
- Mantle cell lymphoma (MCL) who have received at least one prior treatment
- Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL)
- Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion
- Waldenström’s macroglobulinemia (WM)
- Marginal zone lymphoma (MZL) who require a medicine by mouth or injection (systemic therapy) and have received a certain type of prior treatment
- Chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy
It is not known if IMBRUVICA® is safe and effective in children.
Combined Data from Multiple Phase 3 Studies of IMBRUVICA® (ibrutinib) Show Efficacy and Safety in High-Risk, Previously Untreated Chronic Lymphocytic Leukemia (CLL) and Real-World Data Indicating Low Biomarker Testing Rates for These Patients
Sun December 6, 2020 1:00 PM|PR Newswire|About: ABBV
NORTH CHICAGO, Ill., Dec. 6, 2020 /PRNewswire/ -- AbbVie (ABBV),
Please click here for full Prescribing Information.
For more information, please visit http://www.abbvie.com/oncology
For more information about AbbVie, please visit us at www.abbvie.com.
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SOURCE AbbVie
Calquence (acalabrutinib)
KEYTRUDA® (pembrolizumab) Injection, 100 mg
Calquence (acalabrutinib)
For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com.
Calquence (acalabrutinib)
Calquence data across four trials reinforces cardiovascular safety profile in patients with chronic lymphocytic leukaemia
PUBLISHED7 December 2020
7 December 2020 15:00 GMT
Less than 1% of patients treated with Calquence discontinued treatment due to cardiac adverse events in pooled analysis
A pooled analysis of cardiovascular (CV) safety data from 762 patients treated with Calquence (acalabrutinib) monotherapy for chronic lymphocytic leukaemia (CLL), the most common type of adult leukaemia, across four clinical trials showed a low incidence of cardiac adverse events (AEs) leading to discontinuation.1,2 These results were presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition on 7 December 2020.
Calquence (acalabrutinib)
PUBLISHED7 December 2020
7 December 2020 15:00 GMT
Less than 1% of patients treated with Calquence discontinued treatment due to cardiac adverse events in pooled analysis
A pooled analysis of cardiovascular (CV) safety data from 762 patients treated with Calquence (acalabrutinib) monotherapy for chronic lymphocytic leukaemia (CLL), the most common type of adult leukaemia, across four clinical trials showed a low incidence of cardiac adverse events (AEs) leading to discontinuation.1,2 These results were presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition on 7 December 2020.
The analysis included patients with previously untreated and relapsed or refractory CLL treated with Calquence alone from the ELEVATE TN and ASCEND Phase III trials, as well as the 15-H-0016 Phase II trial and ACE-CL-001 Phase I/II trial. In the analysis, 129 patients (17%) reported a cardiac AE of any grade at a median follow up of 25.9 months, and seven patients (0.9%) discontinued treatment due to cardiac AEs.1
Jennifer Brown, MD, PhD, Director of the CLL Center of the Division of Hematologic Malignancies, Dana-Farber Cancer Institute, and principal investigator, said: “Cardiac adverse events have emerged as an important consideration for treating chronic lymphocytic leukaemia patients with Bruton’s tyrosine kinase inhibitors, as cardiovascular complications have become a frequent reason for discontinuation. The data presented in this study suggests a low risk of cardiac adverse events with acalabrutinib that is similar to those in a general population of untreated patients with chronic lymphocytic leukaemia, giving clinicians further reassurance when prescribing this therapy.”
José Baselga, Executive Vice President, Oncology R&D, said: “These combined results across four of our clinical trials reinforce the cardiovascular safety profile of Calquence for the treatment of chronic lymphocytic leukaemia. With Calquence, we aim to selectively target Bruton’s tyrosine kinase to help improve safety and long-term adherence while maintaining outstanding efficacy.”
Median exposure to Calquence was 24.9 months. Cardiac events that occurred in 2% or more of patients included atrial fibrillation (4%), atrial fibrillation/flutter (5%), palpitations (3%) and tachycardia (2%). The incidence of atrial fibrillation was similar to that in a general, previously untreated CLL patient population (6%).1,3
Grade 3 or higher cardiac AEs occurred in 37 patients (4%) treated with Calquence monotherapy, of which 25% were reported during the first six months of treatment. Grade 3 or higher cardiac AEs of interest included atrial fibrillation (1.3%), complete atrioventricular (AV) block (0.3%), acute coronary syndrome (0.1%), atrial flutter (0.1%), second degree AV block (0.1%) and ventricular fibrillation (0.1%). Two patients experienced Grade 5 AEs (one with congestive heart failure and one with heart attack).1
Overall, 91% of patients with cardiac AEs versus 79% patients without cardiac AEs had one or more CV risk factors before receiving Calquence. The most prevalent CV risk factors (greater than or equal to 20% of patients) among those who experienced cardiac AEs were hypertension (67%), hyperlipidemia (29%) and arrhythmias (22%).1
AstraZeneca is exploring additional trials in CLL, including the ELEVATE-RR Phase III trial (ACE-CL-006) evaluating Calquence versus ibrutinib in patients with previously treated high-risk CLL. Data is anticipated in 2021.
Chronic lymphocytic leukaemia
Chronic lymphocytic leukaemia (CLL) is the most common type of leukaemia in adults, with an estimated 105,000 new cases globally in 2016, and the number of people living with CLL is expected to grow with improved treatment as patients live longer with the disease.2,4,5,6 In CLL, too many blood stem cells in the bone marrow become abnormal lymphocytes and these abnormal cells have difficulty fighting infections. As the number of abnormal cells grows, there is less room for healthy white blood cells, red blood cells, and platelets. This could result in anaemia, infection, and bleeding.4 B-cell receptor signalling through Bruton’s tyrosine kinase (BTK) is one of the essential growth pathways for CLL.
Calquence
Calquence (acalabrutinib) is a next-generation, selective inhibitor of BTK. Calquence binds covalently to BTK, thereby inhibiting its activity.7,8 In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.7
Calquence is approved for the treatment of CLL and small lymphocytic lymphoma in the US and is approved for CLL in the EU and several other countries worldwide. Calquence is also approved for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy in the US and several other countries.
As part of an extensive clinical development programme, AstraZeneca and Acerta Pharma are currently evaluating Calquence in more than 20 company-sponsored clinical trials. Calquence is being developed for the treatment of multiple B-cell blood cancers including CLL, MCL, diffuse large B-cell lymphoma, Waldenström’s macroglobulinaemia, follicular lymphoma, and other haematologic malignancies.
What is CALQUENCE?
CALQUENCE is a prescription medicine used to treat adults with mantle cell lymphoma (MCL) who have received at least one prior treatment for their cancer, or adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
It is not known if CALQUENCE is safe and effective in children.
Please see full Prescribing Information, including Patient Information.
CALQUENCE Shows Long-Term Efficacy and Tolerability at Three Years for Patients With Relapsed or Refractory Mantle Cell Lymphoma
Sun December 6, 2020 10:00 AM|Business Wire|About: AZN
ACE-LY-004 Phase II trial results substantiate established efficacy and safety profile of CALQUENCE in mantle cell lymphoma
(WILMINGTON, Del.--(BUSINESS WIRE)
For more information, please visit astrazeneca-us.com
https://seekingalpha.com/symbol/AZN
View source version on businesswire.com: https://www.businesswire.com/news/home/20201206005037/en/
VENCLEXTA®/VENCLYXTO® (venetoclax)
VENCLEXTA®/VENCLYXTO® (venetoclax)
VENCLEXTA®/VENCLYXTO® (venetoclax)
December 5, 2020
AbbVie Presents Extended Follow-Up Data for Fixed Duration Treatment VENCLEXTA®/VENCLYXTO® (venetoclax) in Chronic Lymphocytic Leukemia (CLL)
- New five-year, follow-up analysis from the Phase 3 MURANO trial shows median progression-free survival (PFS) of 53.6 months in previously treated CLL patients taking VENCLEXTA/VENCLYXTO in combination with rituximab compared to 17.0 months in patients taking bendamustine plus rituximab (BR) after three years or more off treatment[1]
- Two analyses of the Phase 3 CLL14 study evaluated minimal residual disease (MRD) measurements for previously untreated CLL patients taking VENCLEXTA/VENCLYXTO in combination with obinutuzumab[2],[3]
- Four-year follow-up analysis from the CLL14 study shows an overall survival (OS) rate of 85.3% with the VENCLEXTA/VENCLYXTO and obinutuzumab combination versus 83.1% with chlorambucil and obinutuzumab combination[3]
NORTH CHICAGO, Ill., Dec. 5, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new, updated results from the Phase 3 MURANO and CLL14 clinical trials evaluating VENCLEXTA®/VENCLYXTO® (venetoclax) fixed duration treatment combinations at the virtual 62nd American Society of Hematology (ASH) Annual Meeting & Exposition (abstracts 125, 127, and 1310, respectively). These findings add to the growing body of data supporting the use of VENCLEXTA/VENCLYXTO in first-line or previously treated chronic lymphocytic leukemia (CLL) patients.
VENCLEXTA®/VENCLYXTO® (venetoclax)
About VENCLEXTA®/VENCLYXTO® (venetoclax)
VENCLEXTA®/VENCLYXTO® (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLEXTA/VENCLYXTO targets the BCL-2 protein and works to help restore the process of apoptosis.
VENCLEXTA/VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood and other cancers. VENCLEXTA/VENCLYXTO is approved in more than 50 countries, including the U.S.
Uses
VENCLEXTA is a prescription medicine used:
- to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly diagnosed acute myeloid leukemia (AML) who:
- are 75 years of age or older, or
- have other medical conditions that prevent the use of standard chemotherapy.
It is not known if VENCLEXTA is safe and effective in children.
See VENCLYXTO full summary of product characteristics (SmPC) at https://www.ema.europa.eu/en/documents/product-information/venclyxto-epar-product-information_en.pdf.
For more information about AbbVie, please visit us at www.abbvie.com.
https://seekingalpha.com/symbol/ABBV
Dupixent® (dupilumab)
VENCLEXTA®/VENCLYXTO® (venetoclax)
VENCLEXTA®/VENCLYXTO® (venetoclax)
Dupixent® (dupilumab)
November 30, 2020 at 12:59 AM EST Back
DUPIXENT® (DUPILUMAB) APPROVED BY EUROPEAN COMMISSION AS FIRST AND ONLY BIOLOGIC MEDICINE FOR CHILDREN AGED 6 TO 11 YEARS WITH SEVERE ATOPIC DERMATITIS
TARRYTOWN, N.Y. and PARIS, Nov. 30, 2020 /PRNewswire/ --
Pivotal trial showed more than four times as many children achieved itch reduction and more than three times as many children achieved clear or almost clear skin with Dupixent plus topical corticosteroids (TCS) compared to TCS alone
Nearly three in four children achieved a 75% improvement in disease extent and severity, with an average improvement of approximately 80%
Approximately 80% of children experienced clinically meaningful improvements in a composite of health-related quality of life measures that include sleep, school, emotional well-being and relationships
Expanded approval of Dupixent for these children reinforces well-established, long-term safety profile
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi
Dupixent® (dupilumab) approved by European Commission as first and only biologic medicine for children aged 6 to 11 years with severe atopic dermatitis
Mon November 30, 2020 1:00 AM|GlobeNewswire|About: SNY
Dupixent® (dupilumab) approved by European Commission as first and only biologic medicine for children aged 6 to 11 years with severe atopic dermatitis
- Pivotal trial showed more than four times as many children achieved itch reduction and more than three times as many children achieved clear or almost clear skin with Dupixent plus topical corticosteroids (TCS) compared to TCS alone
- Nearly three in four children achieved a 75% improvement in disease extent and severity, with an average improvement of approximately 80%
- Approximately 80% of children experienced clinically meaningful improvements in a composite of health-related quality of life measures that include sleep, school, emotional well-being and relationships
- Expanded approval of Dupixent for these children reinforces well-established, long-term safety profile
PARIS and TARRYTOWN, N.Y. – November 30, 2020 – The European Commission (EC)
Dupixent® (dupilumab)
Indications
DUPIXENT is a prescription medicine used:
- to treat people aged 6 years and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. DUPIXENT can be used with or without topical corticosteroids. It is not known if DUPIXENT is safe and effective in children with atopic dermatitis under 6 years of age.
- with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in people aged 12 years and older whose asthma is not controlled with their current asthma medicines. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. DUPIXENT is not used to treat sudden breathing problems. It is not known if DUPIXENT is safe and effective in children with asthma under 12 years of age.
- with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled. It is not known if DUPIXENT is safe and effective in children with chronic rhinosinusitis with nasal polyposis under 18 years of age.
https://www.dupixent.com/
For additional information about the company, please visit www.regeneron.com
https://seekingalpha.com/symbol/REGN
https://www.sanofi.com/
https://seekingalpha.com/symbol/SNY
Forxiga (dapagliflozin)
VENCLEXTA®/VENCLYXTO® (venetoclax)
Jardiance® (empagliflozin)
Forxiga approved in Japan for chronic heart failure
PUBLISHED30 November 2020
30 November 2020 07:00 GMT
Forxiga is the first SGLT2 inhibitor approved in Japan for chronic heart failure with reduced ejection fraction in adult patients with and without type-2 diabetes
AstraZeneca’s Forxiga (dapagliflozin) has been approved in Japan for the treatment of patients with chronic heart failure (HF) who are receiving standard of care.
Forxiga (known as Farxiga in the US) is approved in the US, Europe, and several other countries around the world for the treatment of patients with HF with reduced ejection fraction (HFrEF).
AstraZeneca's Forxiga OK'd in Japan for heart failure
Nov. 30, 2020 6:44 AM ETAstraZeneca PLC (AZN)By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3639857-astrazenecas-forxiga-okd-in-japan-for-heart-failure
Forxiga (dapagliflozin)
What is FARXIGA?
FARXIGA is a prescription medicine used to:
improve blood sugar control along with diet and exercise in adults with type 2 diabetes
reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and known cardiovascular disease or multiple cardiovascular risk factors
reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (when the heart is weak and cannot pump enough blood to the rest of your body)
FARXIGA should not be used to treat people with type 1 diabetes or diabetic ketoacidosis (increased ketones in your blood or urine).
Forxiga
Forxiga (dapagliflozin) is a first-in-class, oral, once-daily SGLT2 inhibitor indicated in adults for the treatment of insufficiently controlled T2D as both monotherapy and as part of combination therapy as an adjunct to diet and exercise to improve glycaemic control, with the additional benefits of weight loss and blood-pressure reduction.
Forxiga has been evaluated in patients with CKD in the Phase III DAPA-CKD trial, with the full results announced in August 2020 demonstrating that Forxiga met all primary and secondary endpoints, providing overwhelming efficacy. Forxiga is currently being tested for patients with HF in the DELIVER (HF with preserved ejection fraction, HFpEF) and DETERMINE (HFrEF and HFpEF) Phase III trials. Forxiga will also be tested in patients without T2D following an acute myocardial infarction (MI) or heart attack in the DAPA-MI trial - a first of its kind, indication-seeking registry-based randomised controlled trial. Forxiga has a robust programme of clinical trials that includes more than 35 completed and ongoing Phase IIb/III trials in more than 35,000 patients, as well as more than 2.5 million patient-years’ experience.
The approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) was based on positive results from the landmark DAPA-HF Phase III trial published in The New England Journal of Medicine.7
Please visit astrazeneca.com
https://seekingalpha.com/symbol/AZN
Jardiance® (empagliflozin)
Jardiance® (empagliflozin)
Jardiance® (empagliflozin)
Jardiance® reduced the risk of first plus recurrent cardiovascular events in adults with type 2 diabetes and established cardiovascular disease in new analysis from the EMPA-REG OUTCOME® trial
Wed November 18, 2020 8:00 AM|PR Newswire|About: LLY
- Recurrent cardiovascular events in people with type 2 diabetes are responsible for considerable clinical and socioeconomic burdens; evaluation of first and recurrent events allows estimation of the total burden of cardiovascular events
PR Newswire
RIDGEFIELD, Conn. and INDIANAPOLIS, Nov. 18, 2020 /PRNewswire/ -- Jardiance® (empagliflozin)
Jardiance® (empagliflozin)
What is JARDIANCE? (www.jardiance.com)
JARDIANCE is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
JARDIANCE is also used to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.
JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
For more information, please see Prescribing Information and Medication Guide.
For more information, please visit www.boehringer-ingelheim.us
For the latest updates, visit http://www.lillydiabetes.com/
Lilly, please visit us at lilly.com
View original content to download multimedia:http://www.prnewswire.com/news-releases/jardiance-reduced-the-risk-of-first-plus-recurrent-cardiovascular-events-in-adults-with-type-2-diabetes-and-established-cardiovascular-disease-in-new-analysis-from-the-empa-reg-outcome-trial-301175351.html
November 18, 2020
Tags | Product
Lilly's Jardiance reduced risk of cardiovascular events in adults with type 2 diabetes
Nov. 18, 2020 8:46 AM ET Eli Lilly and Company (LLY) By: Mamta Mayani, SA News Editor2
https://seekingalpha.com/symbol/LLY
OPDIVO® (nivolumab)
Jardiance® (empagliflozin)
Imfinzi (durvalumab)
Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) as Second-Line Treatment for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
Tue November 24, 2020 6:59 AM|Business Wire|About: BMY
First immunotherapy to be approved for a gastroesophageal cancer in the European Union
Approval based on Phase 3 ATTRACTION-3 trial showing statistically significant and clinically meaningful improvement in overall survival compared to chemotherapy
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)
ATTRACTION-3 (ONO-4538-24/CA209-473; NCT02569242) is a Phase 3, multi-center, randomized, open-label global study, evaluating Opdivo versus chemotherapy (docetaxel or paclitaxel) for patients with esophageal cancer refractory or intolerant to first-line combination therapy with fluoropyrimidine- and platinum-based drugs.
OPDIVO® (nivolumab)
OPDIVO® Immunotherapy: Giving People a Choice and a Chance Against Their Cancer
ADVANCED LUNG CANCER
NON-SMALL CELL LUNG CANCER
- OPDIVO + YERVOY for certain adults with newly diagnosed advanced non-small cell lung cancer that tests positive for PD-L1
- OPDIVO + YERVOY, in combination with chemotherapy, for adults with newly diagnosed advanced non-small cell lung cancer
- OPDIVO for people who have had prior treatments for non-small cell lung cancer
SMALL CELL LUNG CANCER
Choose your condition:
- Advanced Lung Cancer
- Advanced Kidney Cancer
- Advanced Liver Cancer
- Colorectal Cancer (MSI-H/dMMR)
- Advanced Esophageal Squamous Cell Cancer
- Melanoma
- Head and Neck Squamous Cell Cancer
- Advanced Bladder Cancer
- Classical Hodgkin Lymphoma
For more information about Bristol Myers Squibb, visit us at BMS.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20201124005397/en/
11/24/2020
Bristol Myers wins EU approval of Opdivo for esophageal cancer
Nov. 24, 2020 11:22 AM ETBristol-Myers Squibb Company (BMY)By: Carl Surran, SA News Editor
https://seekingalpha.com/news/3639128-bristol-myers-wins-eu-approval-of-opdivo-for-esophageal-cancer
https://seekingalpha.com/symbol/BMY
Imfinzi (durvalumab)
Jardiance® (empagliflozin)
Imfinzi (durvalumab)
Imfinzi approved in the US for less-frequent, fixed-dose use
PUBLISHED 20 November 2020
20 November 2020 07:00 GMT
Four-week dosing now approved in all Imfinzi indications, reducing medical visits and improving patient convenience
AstraZeneca’s Imfinzi (durvalumab)
AstraZeneca’s additional Imfinzi fixed-dose OK'd in U.S.
Nov. 20, 2020 3:22 AM ET AstraZeneca PLC (AZN)By: Mamta Mayani, SA News Editor
https://seekingalpha.com/news/3638225-astrazeneca-s-additional-imfinzi-fixed-dose-okd-in-u-s
Imfinzi (durvalumab)
What is IMFINZI?
IMFINZI® (durvalumab) is a prescription medicine used to treat adults with a type of cancer in the bladder and urinary tract called urothelial carcinoma. IMFINZI may be used when your urothelial carcinoma has spread or cannot be removed by surgery, and chemotherapy containing platinum did not work or is no longer working. IMFINZI was FDA approved for this use based on a clinical study that measured how many patients responded and how long they responded. The study is ongoing to confirm clinical benefit.
IMFINZI is a prescription medicine used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC). IMFINZI may be used when your NSCLC has not spread outside your chest, cannot be removed by surgery, and has responded or stabilized with initial treatment with chemotherapy that contains platinum, given at the same time as radiation therapy.
IMFINZI is a prescription medicine used to treat adults with a type of lung cancer called small cell lung cancer (SCLC). IMFINZI may be used with the chemotherapy medicines etoposide and carboplatin or cisplatin as your first treatment when your SCLC has spread within your lungs or to other parts of the body (extensive-stage small cell lung cancer, or ES-SCLC).
It is not known if IMFINZI is safe and effective in children.
Please visit astrazeneca.com
https://seekingalpha.com/symbol/AZN
biotecMAX™ November & October 2020 insight
INO-5401 + INO-9012 in Novel Combination with PD-1 Inhibitor Libtayo® (cemiplimab)
INO-5401 + INO-9012 in Novel Combination with PD-1 Inhibitor Libtayo® (cemiplimab)
INO-5401 + INO-9012 in Novel Combination with PD-1 Inhibitor Libtayo® (cemiplimab)
INOVIO Presents Clinical Results of its DNA Medicines INO-5401 + INO-9012 in Novel Combination with PD-1 Inhibitor Libtayo® (cemiplimab) in the Treatment of Newly Diagnosed Glioblastoma Multiforme at Society for Neuro-Oncology 2020 Annual Meeting
Fri November 20, 2020 8:00 AM|PR Newswire| About: INO PR Newswire
PLYMOUTH MEETING, Pa., Nov. 20, 2020 /PRNewswire/ -- INOVIO (NASDAQ: INO)
INO-5401 + INO-9012 in Novel Combination with PD-1 Inhibitor Libtayo® (cemiplimab)
About INO-5401 and INO-9012
INO-5401 encodes for INOVIO's SynCon® antigens for hTERT, WT1, and PSMA, and has the potential to be a powerful cancer immunotherapy in combination with checkpoint inhibitors. The National Cancer Institute previously highlighted hTERT, WT1, and PSMA among a list of important cancer antigens, designating them as high priorities for cancer immunotherapy development. These three antigens were reported to be over-expressed, and often mutated, in a variety of human cancers, and targeting these antigens may prove efficacious in the treatment of patients with cancer. INO-9012 encodes for IL-12, which is a T cell immune activator.
For more information, visit www.inovio.com.
View original content:
https://seekingalpha.com/symbol/INO
DNA MEDICINES PIPELINE
INOVIO is leveraging its optimized plasmid design and delivery technology to develop DNA medicines to potentially treat and prevent diseases associated with human papillomavirus (HPV), cancer, and infectious diseases.
https://www.inovio.com/dna-medicines-pipeline/
What is LIBTAYO?
LIBTAYO is a prescription medicine used to treat people with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation.
https://seekingalpha.com/symbol/REGN
https://seekingalpha.com/symbol/SNY
KEYTRUDA® (pembrolizumab) in Combination With Chemotherapy
INO-5401 + INO-9012 in Novel Combination with PD-1 Inhibitor Libtayo® (cemiplimab)
INO-5401 + INO-9012 in Novel Combination with PD-1 Inhibitor Libtayo® (cemiplimab)
FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Chemotherapy for Patients With Locally Recurrent Unresectable or Metastatic Triple‑Negative Breast Cancer Whose Tumors Express PD-L1 (CPS ≥10)
November 13, 2020 4:10 pm EST
First Approval for KEYTRUDA in the Breast Cancer Setting
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK),
KEYTRUDA® (pembrolizumab) in Combination With Chemotherapy
FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Chemotherapy for Patients With Locally Recurrent Unresectable or Metastatic Triple‑Negative Breast Cancer Whose Tumors Express PD-L1 (CPS ≥10)
Fri November 13, 2020 4:10 PM|Business Wire|About: MRK
First Approval for KEYTRUDA in the Breast Cancer Setting
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK)
A BREAKTHROUGH IMMUNOTHERAPY THAT MAY HELP YOU FACE YOUR CANCER
IT’S TRU. KEYTRUDA.
SELECT A TYPE OF CANCER
- Advanced non–small cell lung cancer
- Melanoma
- Head and neck squamous cell cancer
- High-risk non-muscle invasive bladder cancer (NMIBC)
- Advanced urothelial bladder cancer
- Advanced kidney cancer (RCC)
- Advanced MSI-H/dMMR colorectal cancer
- Microsatellite instability-high cancer (MSI-H/dMMR)
- Classical Hodgkin lymphoma (cHL)
- Advanced gastric cancer
- Advanced cervical cancer
- Primary mediastinal B‑cell lymphoma (PMBCL)
- Advanced liver cancer (HCC)
- Advanced Merkel cell carcinoma
- Advanced esophageal squamous cell carcinoma
- Cutaneous squamous cell carcinoma (cSCC)
The accelerated approval was based on data from KEYNOTE-355 (ClinicalTrials.gov, NCT02819518), a multicenter, double-blind, randomized, placebo-controlled trial conducted in 847 patients with locally recurrent unresectable or metastatic TNBC, regardless of tumor PD-L1 expression, who had not been previously treated with chemotherapy in the metastatic setting. Patients were randomized (2:1) to receive either KEYTRUDA (200 mg on Day 1 every three weeks) or placebo (on Day 1 every three weeks) in combination with the following chemotherapy; all medications were administered via intravenous infusion:
More information is available by calling 855-257-3932 or visiting www.merckaccessprogram-keytruda.com.
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20201113005691/en/
https://seekingalpha.com/symbol/MRK
KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib)
INO-5401 + INO-9012 in Novel Combination with PD-1 Inhibitor Libtayo® (cemiplimab)
KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib)
KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Demonstrated Statistically Significant Improvement in Progression-Free Survival (PFS), Overall Survival (OS) and Objective Response Rate (ORR) Versus Sunitinib as First-Line Treatment for Patients…
Tue November 10, 2020 6:45 AM|Business Wire|About: MRK
LENVIMA Plus Everolimus Also Showed Statistically Significant Improvement in PFS and ORR Endpoints Versus Sunitinib
Results of Investigational Phase 3 KEYNOTE-581/CLEAR Trial (Study 307) to be Presented at Upcoming Medical Meeting
KENILWORTH, N.J., & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)-- Merck (MRK):
KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Demonstrated Statistically Significant Improvement in Progression-Free Survival (PFS), Overall Survival (OS) and Objective Response Rate (ORR) Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma
About KEYNOTE-581/CLEAR (Study 307)
KEYNOTE-581/CLEAR (Study 307) is a multi-center, randomized, open-label, Phase 3 trial (ClinicalTrials.gov, NCT02811861) evaluating LENVIMA in combination with KEYTRUDA or in combination with everolimus versus sunitinib for the first-line treatment of patients with advanced RCC.
Please see Prescribing Information for LENVIMA (lenvatinib) at http://www.lenvima.com/pdfs/prescribing-information.pdf.
For more information, visit www.merck.com
For more information about Eisai, please visit www.eisai.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20201110005450/en/
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)
A BREAKTHROUGH IMMUNOTHERAPY THAT MAY HELP YOU FACE YOUR CANCER
IT’S TRU. KEYTRUDA.
SELECT A TYPE OF CANCER
- Advanced non–small cell lung cancer
- Melanoma
- Head and neck squamous cell cancer
- High-risk non-muscle invasive bladder cancer (NMIBC)
- Advanced urothelial bladder cancer
- Advanced kidney cancer (RCC)
- Advanced MSI-H/dMMR colorectal cancer
- Microsatellite instability-high cancer (MSI-H/dMMR)
- Classical Hodgkin lymphoma (cHL)
- Advanced gastric cancer
- Advanced cervical cancer
- Primary mediastinal B‑cell lymphoma (PMBCL)
- Advanced liver cancer (HCC)
- Advanced Merkel cell carcinoma
- Advanced esophageal squamous cell carcinoma
- Cutaneous squamous cell carcinoma (cSCC)
Two treatments. One combination to help fight cancer.
KEYTRUDA + LENVIMA
KEYTRUDA and LENVIMA in Combination
KEYTRUDA and LENVIMA are prescription medicines used together to treat a kind of uterine cancer called advanced endometrial carcinoma:
- that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and
- that has been treated with an anti-cancer medicine, and it did not work or is no longer working, and
- that cannot be cured by surgery or radiation.
This use is approved based on how many patients responded to treatment and how long they responded. Studies are ongoing to provide additional information about clinical benefit.
It is not known if LENVIMA is safe and effective in children.
https://www.keytrudalenvima.com/advanced-endometrial-cancer/
https://www.keytrudalenvima.com/advanced-endometrial-cancer/
Opdivo (nivolumab) plus Yervoy (ipilimumab)
Opdivo (nivolumab) plus Yervoy (ipilimumab)
KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib)
Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) with Two Cycles of Chemotherapy for First-Line Treatment of Metastatic Non-Small Cell Lung Cancer
Approval based on Phase 3 CheckMate -9LA trial results showing superior overall survival in patients with metastatic non-small cell lung cancer, regardless of PD-L1 expression or tumor histologies
European Commission decision marks the first time a dual immunotherapy with limited chemotherapy is approved for patients with non-small cell lung cancer in the EU
Opdivo plus Yervoy-based combinations now indicated in the EU for three different advanced cancer types: non-small cell lung cancer, melanoma and renal cell carcinoma
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab)
https://www.opdivoyervoymnsclc.com/
For Patients With Metastatic Non-Small Cell Lung Cancer
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, in combination with YERVOY 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 (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.
Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) with Two Cycles of Chemotherapy for First-Line Treatment of Metastatic Non-Small Cell Lung Cancer
11/06/2020CATEGORY:
Approval based on Phase 3 CheckMate -9LA trial results showing superior overall survival in patients with metastatic non-small cell lung cancer, regardless of PD-L1 expression or tumor histologies
European Commission decision marks the first time a dual immunotherapy with limited chemotherapy is approved for patients with non-small cell lung cancer in the EU
Opdivo plus Yervoy-based combinations now indicated in the EU for three different advanced cancer types: non-small cell lung cancer, melanoma and renal cell carcinoma
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY
https://news.bms.com/news/corporate-financial/2020/Bristol-Myers-Squibb-Receives-European-Commission-Approval-for-Opdivo-nivolumab-plus-Yervoy-ipilimumab-with-Two-Cycles-of-Chemotherapy-for-First-Line-Treatment-of-Metastatic-Non-Small-Cell-Lung-Cancer/default.aspx
View source version on businesswire.com: https://www.businesswire.com/news/home/20201106005029/en/
https://seekingalpha.com/symbol/BMY
https://www.opdivoyervoymnsclc.com/
XTANDI® (enzalutamide soft capsules)
Opdivo (nivolumab) plus Yervoy (ipilimumab)
XTANDI® (enzalutamide soft capsules)
XTANDI® (enzalutamide soft capsules) Approved by China NMPA for the Treatment of Non-Metastatic Castration-Resistant Prostate Cancer
Fri November 6, 2020 2:00 AM|PR Newswire|About: ALPMY, PFEPR Newswire
TOKYO, Nov. 6, 2020 /PRNewswire/ -- Astellas Pharma Inc. (ALPMF) (TSE: 4503
These results were published in the New England Journal of Medicine in 2018. Results from the study's overall survival secondary endpoint were published in the New England Journal of Medicine in 2020.
XTANDI® (enzalutamide soft capsules)
What is XTANDI?
XTANDI is a prescription medicine used to treat men with prostate cancer that:
- no longer responds to a hormone therapy or surgical treatment to lower testosterone
- OR
- has spread to other parts of the body and responds to a hormone therapy or surgical treatment to lower testosterone
It is not known if XTANDI is safe and effective in females or children.
For more information, please visit our website at https://www.astellas.com/en.
XTANDI® (enzalutamide soft capsules) Approved by China NMPA for the Treatment of Non-Metastatic Castration-Resistant Prostate Cancer
Nov 06, 2020
Enzalutamide is now NMPA-approved for both non-metastatic and metastatic castration-resistant prostate cancer
TOKYO, November 6, 2020 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that the China National Medical Products Administration (NMPA) has approved XTANDI® (enzalutamide soft capsules) for the treatment of adult men with non-metastatic castration-resistant prostate cancer (nmCRPC) with high risk of metastasis. This is the second approved indication in China for enzalutamide, which is already available for adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT), in whom chemotherapy is not yet indicated.
https://www.astellas.com/en/news/16156
View original content to download multimedia:http://www.prnewswire.com/news-releases/xtandi-enzalutamide-soft-capsules-approved-by-china-nmpa-for-the-treatment-of-non-metastatic-castration-resistant-prostate-cancer-301167743.html
https://seekingalpha.com/symbol/ALPMF
About the Pfizer (PFE)/Astellas Collaboration
In October 2009, Medivation, Inc. (MDVN), which is now part of Pfizer, 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.
Zejula (niraparib)
Opdivo (nivolumab) plus Yervoy (ipilimumab)
XTANDI® (enzalutamide soft capsules)
29 October 2020
European Commission approves Zejula (niraparib) as first-line monotherapy maintenance treatment in advanced ovarian cancer
For media and investors only
Issued: London, UK
- Zejula is the first PARP inhibitor approved as monotherapy in the European Union for patients with platinum-responsive advanced ovarian cancer, regardless of biomarker status
GlaxoSmithKline (GSK) plc
Zejula (niraparib)
Indication
ZEJULA is a prescription medicine used for the:
- maintenance treatment of adults with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. ZEJULA is used after the cancer has responded (complete or partial response) to treatment with platinum-based chemotherapy.
- maintenance treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that comes back. ZEJULA is used after the cancer has responded (complete or partial response) to treatment with platinum-based chemotherapy.
- treatment of adults with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have been treated with 3 or more prior types of chemotherapy and who have tumors with:
- a certain "BRCA" gene mutation, or
- gene mutation problems and who have progressed more than 6 months after their last treatment with platinum-based chemotherapy.
- Your healthcare provider will perform a test to make sure that ZEJULA is right for you.
It is not known if ZEJULA is safe and effective in children.
Expanded use of Glaxo's Zejula OK'd in Europe
Oct. 29, 2020 10:24 AM ET|About: GlaxoSmithKline plc (GSK)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3628351-expanded-use-of-glaxos-zejula-okd-in-europe
https://seekingalpha.com/symbol/GSK
aducanumab
Tecentriq (atezolizumab) and Avastin (bevacizumab)
Tecentriq (atezolizumab) and Avastin (bevacizumab)
European Medicines Agency Accepts Biogen’s Aducanumab Marketing Authorization Application for Alzheimer's Disease
Fri October 30, 2020 7:00 AM|GlobeNewswire|About: BIIB
- If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and to meaningfully change the course of Alzheimer’s disease
CAMBRIDGE, Mass. and TOKYO, Oct. 30, 2020 (GLOBE NEWSWIRE) -- Biogen (BIIB) and Eisai, Co., Ltd. (Tokyo, Japan)
We routinely post information that may be important to investors on our website at www.biogen.com.
For more information about Eisai Co., Ltd., please visit https://www.eisai.com.
Innovation in Alzheimer's
https://www.biogen.com/en_us/alzheimers-center.html
https://seekingalpha.com/symbol/BIIB
The company has a lot riding on a nod in either or both jurisdictions since it has an acute need for a growth driver. The company is optimistic about approval based on the totality of the data. Results from two Phase 3 studies were uneven however. In the EMERGE trial. the high-dose arm met the primary and two secondary endpoints at week 78 but the low-dose arm missed all endpoints. In the ENGAGE study, both the high-dose and low-dose arms failed to achieve the primary or secondary endpoints.
https://www.eisai.com/index.html
European Medicines Agency Accepts Biogen’s Aducanumab Marketing Authorization Application for Alzheimer's Disease If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and to meaningfully change the course of Alzheimer’s disease
CAMBRIDGE, Mass. and TOKYO, October 30, 2020 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan)
https://www.eisai.com/news/2020/news202070.html
Tecentriq (atezolizumab) and Avastin (bevacizumab)
Tecentriq (atezolizumab) and Avastin (bevacizumab)
Tecentriq (atezolizumab) and Avastin (bevacizumab)
Roche’s Tecentriq in combination with Avastin approved in China for people with the most common form of liver cancer
- Tecentriq in combination with Avastin is the first and only cancer immunotherapy regimen approved for the treatment of unresectable hepatocellular carcinoma (HCC), the most common form of liver cancer
- The Tecentriq combination improved overall survival and progression-free survival compared with sorafenib in people with unresectable HCC
- Approval by the China National Medical Products Administration brings a new treatment option to HCC patients in China, where almost half of all cases worldwide are found
Basel, 29 October 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY)
For more information, please visit www.roche.com.
Roche doublet therapy OK'd in China for first-line liver cancer
Oct. 29, 2020 7:02 AM ET|About: Roche Holding AG (RHHBY)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3628076-roche-doublet-therapy-okd-in-china-for-first-line-liver-cancer
https://seekingalpha.com/symbol/RHHBY
TECENTRIQ may work with your immune system to fight cancer
Avastin® (bevacizumab) is a tumor-starving (anti-angiogenic) therapy. Avastin is designed to block a protein called vascular endothelial growth factor, or VEGF. Normal cells make VEGF, but some cancer cells make too much VEGF. Blocking VEGF may prevent the growth of new blood vessels, including normal blood vessels and blood vessels that feed tumors.
Indication
Metastatic Colorectal Cancer (mCRC)
Avastin is approved to treat metastatic colorectal cancer (mCRC) for:
- First- or second-line treatment in combination with intravenous fluorouracil–based chemotherapy
- Second-line treatment when used with fluoropyrimidine-based (combined with irinotecan or oxaliplatin) chemotherapy after cancer progresses following a first-line treatment that includes Avastin
Avastin is not approved for use after surgery was used as the primary treatment in patients with colon cancer which has not spread to other parts of the body.
Tecentriq (atezolizumab) and Avastin (bevacizumab)
European Commission approves Roche’s Tecentriq in combination with Avastin for the treatment of people with the most common form of liver cancer
- Tecentriq in combination with Avastin is the first and only cancer immunotherapy regimen approved in Europe for the treatment of unresectable hepatocellular carcinoma (HCC), the most common form of liver cancer
- Tecentriq combination improved overall survival and progression-free survival compared with the previous standard of care
Basel, 2 November 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
https://www.roche.com/media/releases/med-cor-2020-11-02.htm?source=news_body_link
Roche doublet therapy for first-line liver cancer approved in Europe
Nov. 2, 2020 6:50 AM ET |About: Roche Holding AG (RHHBY)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/symbol/RHHBY
Libtayo® (cemiplimab-rwlc)
Tecentriq (atezolizumab) and Avastin (bevacizumab)
THOR-707 and KEYTRUDA® (pembrolizumab)
FDA Accepts for Priority Review Libtayo® (cemiplimab-rwlc) for Advanced Non-small Cell Lung Cancer with PD-L1 Expression of ≥50%
Thu October 29, 2020 7:00 AM|PR Newswire|About: REGN
TARRYTOWN, N.Y., Oct. 29, 2020 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (REGN)
Libtayo® (cemiplimab-rwlc)
Please see full Prescribing Information, including Medication Guide.
What is LIBTAYO?
LIBTAYO is a prescription medicine used to treat people with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation.
It is not known if LIBTAYO is safe and effective in children.
For additional information about the company, please visit www.regeneron.com
View original content:http://www.prnewswire.com/news-releases/fda-accepts-for-priority-review-libtayo-cemiplimab-rwlc-for-advanced-non-small-cell-lung-cancer-with-pd-l1-expression-of-50-301162428.html
https://seekingalpha.com/symbol/REGN
October 29, 2020 at 7:00 AM EDT Back
FDA ACCEPTS FOR PRIORITY REVIEW LIBTAYO® (CEMIPLIMAB-RWLC) FOR ADVANCED NON-SMALL CELL LUNG CANCER WITH PD-L1 EXPRESSION OF ≥50%
TARRYTOWN, N.Y., Oct. 29, 2020 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)
THOR-707 and KEYTRUDA® (pembrolizumab)
THOR-707 and KEYTRUDA® (pembrolizumab)
THOR-707 and KEYTRUDA® (pembrolizumab)
Sanofi to evaluate the safety and efficacy of novel investigational candidate THOR-707 and KEYTRUDA® (pembrolizumab) in pursuit of establishing a new treatment option in oncology
Thu October 29, 2020 2:00 AM|GlobeNewswire|About: SNY
Sanofi (SNY) to evaluate the safety and efficacy of novel investigational candidate THOR-707 and KEYTRUDA® (pembrolizumab) in pursuit of establishing a new treatment option in oncology
*THOR-707 (SAR444245) is a non-alpha IL-2 candidate with a best-in-class profile currently being evaluated in Phase 1 trials for the treatment of solid tumors
PARIS – October 29, 2020 – Sanofi has entered into an agreement with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the U.S. and Canada)
THOR-707 and KEYTRUDA® (pembrolizumab)
THOR-707 has the potential to be a best-in-class IL-2 therapeutic for the treatment of many types of malignancies and may demonstrate improved pharmacology allowing for less frequent dosing. In pre-clinical experiments, THOR-707 shows striking synergy with anti-PD-1 therapeutics.
October 29 2020
Sanofi to evaluate the safety and efficacy of novel investigational candidate THOR-707 and KEYTRUDA® (pembrolizumab) in pursuit of establishing a new treatment option in oncology
https://www.sanofi.com/en/media-room/press-releases/2020/2020-10-29-07-00-00
https://seekingalpha.com/symbol/SNY
Sanofi (NASDAQ:SNY) inks agreement with Merck (NYSE:MRK) to conduct a Phase 2 clinical trial to evaluate the safety, pharmacokinetics, and preliminary efficacy of THOR-707, a highly differentiated non-alpha IL-2 candidate combined with or in sequenced administration with MRK's Keytruda (pembrolizumab) in patients with various cancers.
SELECT A TYPE OF CANCER
- Advanced non–small cell lung cancer
- Melanoma
- Head and neck squamous cell cancer
- High-risk non-muscle invasive bladder cancer (NMIBC)
- Advanced urothelial bladder cancer
- Advanced kidney cancer (RCC)
- Advanced MSI-H/dMMR colorectal cancer
- Microsatellite instability-high cancer (MSI-H/dMMR)
- Classical Hodgkin lymphoma (cHL)
- Advanced gastric cancer
- Advanced cervical cancer
- Primary mediastinal B‑cell lymphoma (PMBCL)
- Advanced liver cancer (HCC)
- Advanced Merkel cell carcinoma
- Advanced esophageal squamous cell carcinoma
- Cutaneous squamous cell carcinoma (cSCC)
https://seekingalpha.com/symbol/MRK
Merck sets ulta-high bar with impressive development of Keytruda
Oct. 31, 2020 12:30 AM ET |About: Merck & Co., Inc. (MRK)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3628459-merck-sets-ulta-high-bar-impressive-development-of-keytruda
Keytruda (pembrolizumab) for a mid-stage study evaluating the PD-1 inhibitor with THOR-707, a "not-alpha" interleukin-2 (long-acting version of the immune system-stimulating protein), in a range of cancers.
Forxiga (dapagliflozin).
THOR-707 and KEYTRUDA® (pembrolizumab)
Forxiga (dapagliflozin).
Forxiga cardiovascular outcomes benefit approved in China
PUBLISHED28 October 2020
28 October 2020 07:00 GMT
Update to approval includes DECLARE-TIMI 58 Phase III trial that reduced the risk of composite of hospitalisation for heart failure or cardiovascular death in type-2 diabetes
China’s National Medical Products Administration (NMPA) has updated the label for AstraZeneca’s Forxiga (dapagliflozin) to include data from the DECLARE-TIMI 58 Phase III trial.
DECLARE-TIMI 58 demonstrated that Forxiga achieved a statistically significant reduction in the composite endpoint of hospitalisation for heart failure (hHF) or cardiovascular (CV) death, versus placebo, in adults with type-2 diabetes (T2D) and established CV disease or multiple CV risk factors. The trial confirmed the well-established safety profile of Forxiga.1
DECLARE-TIMI 58 is the largest sodium-glucose cotransporter 2 (SGLT2) inhibitor CV outcomes trial conducted to date, and data from the trial were published in The New England Journal of Medicine in January 2019.
CV benefit claim for AstraZeneca's dapagliflozin OK'd in China
Oct. 28, 2020 7:16 AM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3627101-cv-benefit-claim-for-astrazenecas-dapagliflozin-okd-in-china
What is FARXIGA?
FARXIGA is a prescription medicine used to:
improve blood sugar control along with diet and exercise in adults with type 2 diabetes
reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and known cardiovascular disease or multiple cardiovascular risk factors
reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (when the heart is weak and cannot pump enough blood to the rest of your body)
FARXIGA should not be used to treat people with type 1 diabetes or diabetic ketoacidosis (increased ketones in your blood or urine).
Please see full Prescribing Information and Medication Guide for FARXIGA.
You may report side effects related to AstraZeneca products by clicking here.
https://seekingalpha.com/symbol/AZN
Imfinzi approved in the US for less-frequent, fixed-dose use
PUBLISHED20 November 2020
20 November 2020 07:00 GMT
Four-week dosing now approved in all Imfinzi indications, reducing medical visits and improving patient convenience
Veklury® (remdesivir)
THOR-707 and KEYTRUDA® (pembrolizumab)
Forxiga (dapagliflozin).
October 22, 2020
U.S. Food and Drug Administration Approves Gilead’s Antiviral Veklury® (remdesivir) for Treatment of COVID-19
-- Veklury Is First and Only FDA-Approved Treatment for COVID-19 in the United States --
-- Veklury Shortened Time to Recovery By Five Days in Hospitalized COVID-19 Patients --
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD)
please review the Fact Sheets and FDA Letter of Authorization available at www.gilead.com/remdesivir.
For more information on Gilead’s response to the coronavirus outbreak please visit the company’s dedicated page: https://www.gilead.com/purpose/advancing-global-health/covid-19.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201022006149/en/
Veklury® (remdesivir)
https://www.gilead.com/remdesivir
FDA OKs Gilead's remdesivir
Oct. 22, 2020 4:01 PM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/symbol/GILD
October 20, 2020
Final report confirms remdesivir benefits for COVID-19
https://seekingalpha.com/news/3625009-fda-oks-gileads-remdesivir
Prognosis
Gilead Virus Therapy Remdesivir Gains Approval From FDA
By Robert Langreth October 22, 2020, 4:06 PM EDT Updated on October 22, 2020, 4:55 PM EDT
- Antiviral medicine becomes first approved drug for Covid-19
- Hospital patients who got the drug recovered five days faster
Gilead Sciences' remdesivir cuts COVID-19 death risk in patients on low-flow oxygen
by Eric Sagonowsky | Oct 9, 2020 9:13am
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214787Orig1s000Sumr.pdf
Gilead's remdesivir wins positive opinion from EU for COVID-19
Dec. 11, 2020 3:10 PM ET Gilead Sciences, Inc. (GILD)By: Vandana Singh, SA News Editor
Restriction of indication for Veklury
The CHMP adopted a positive opinion recommending a change to the product information for Veklury (remdesivir) to provide clearer instructions in which COVID-19 patients requiring supplementary oxygen it should be used. More information on the new indication is available on the summary of opinion document in the grid below.
https://stories.gilead.com/articles/open-letter-from-merdad-parsey
https://seekingalpha.com/symbol/GILD
BIOTECNOVA™
OPDIVO® (nivolumab) in Combination with CABOMETYX® (cabozantinib)
OPDIVO® (nivolumab) in Combination with CABOMETYX® (cabozantinib)
OPDIVO® (nivolumab) in Combination with CABOMETYX® (cabozantinib)
U.S. Food and Drug Administration Accepts for Priority Review Applications for OPDIVO® (nivolumab) in Combination with CABOMETYX® (cabozantinib) in Advanced Renal Cell Carcinoma
Mon October 19, 2020 6:59 AM|Business Wire|About: BMY, EXEL
U.S. Food and Drug Administration assigned a target action date of February 20, 2021
Applications based on pivotal Phase 3 CheckMate -9ER trial, which showed OPDIVO in combination with CABOMETYX improved overall survival, doubled median progression-free survival and objective response rate, and demonstrated a manageable safety profile
Results from CheckMate -9ER recently presented during a Presidential Symposium at the European Society for Medical Oncology Virtual Congress 2020
PRINCETON, N.J. & ALAMEDA, Calif.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) and Exelixis, Inc. (EXEL) (NASDAQ: EXEL)
OPDIVO® (nivolumab) in Combination with CABOMETYX® (cabozantinib)
OPDIVO® Immunotherapy: Giving People a Choice and a Chance Against Their Cancer
ADVANCED LUNG CANCER
NON-SMALL CELL LUNG CANCER
- OPDIVO + YERVOY for certain adults with newly diagnosed advanced non-small cell lung cancer that tests positive for PD-L1
- OPDIVO + YERVOY, in combination with chemotherapy, for adults with newly diagnosed advanced non-small cell lung cancer
- OPDIVO for people who have had prior treatments for non-small cell lung cancer
SMALL CELL LUNG CANCER
Choose your condition:
- Advanced Lung Cancer
- Advanced Kidney Cancer
- Advanced Liver Cancer
- Colorectal Cancer (MSI-H/dMMR)
- Advanced Esophageal Squamous Cell Cancer
- Melanoma
- Head and Neck Squamous Cell Cancer
- Advanced Bladder Cancer
- Classical Hodgkin Lymphoma
What is CABOMETYX?
CABOMETYX is a prescription medicine used to treat people with:
- Advanced kidney cancer (renal cell carcinoma)
- Liver cancer (hepatocellular carcinoma) who have been previously treated with the medicine sorafenib.
It is not known if CABOMETYX is safe and effective in children.
Please see accompanying full Prescribing Information: https://cabometyx.com/downloads/CABOMETYXUSPI.pdf.
For more information about Bristol Myers Squibb, visit us at BMS.com
U.S. Food and Drug Administration Accepts for Priority Review Applications for OPDIVO® (nivolumab) in Combination with CABOMETYX® (cabozantinib) in Advanced Renal Cell Carcinoma
10/19/2020CATEGORY:
U.S. Food and Drug Administration assigned a target action date of February 20, 2021
Applications based on pivotal Phase 3 CheckMate -9ER trial, which showed OPDIVO in combination with CABOMETYX improved overall survival, doubled median progression-free survival and objective response rate, and demonstrated a manageable safety profile
Results from CheckMate -9ER recently presented during a Presidential Symposium at the European Society for Medical Oncology Virtual Congress 2020
PRINCETON, N.J. & ALAMEDA, Calif.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) and Exelixis, Inc. (NASDAQ: EXEL)
For more information about Exelixis, please visit www.exelixis.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20201019005198/en/
https://seekingalpha.com/symbol/EXEL
https://seekingalpha.com/symbol/BMY
Exelixis Announces Takeda and Ono Submit Supplemental Application for CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) for the Treatment of Unresectable, Advanced or Metastatic Renal Cell Carcinoma in Japan
Tue October 27, 2020 1:02 AM |Business Wire|About: EXEL
– Submission based on the CheckMate -9ER phase 3 pivotal trial, which showed CABOMETYX in combination with OPDIVO improved overall survival and doubled median progression-free survival and objective response rate versus sunitinib –
ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (EXEL) (NASDAQ: EXEL) today announced that Takeda Pharmaceutical Company Limited (Takeda (TKPHF)), its partner responsible for the clinical development and commercialization of CABOMETYX® (cabozantinib) in Japan, and Ono Pharmaceutical Co., Ltd. (Ono), have submitted a supplemental application to the Japanese Ministry of Health, Labour and Welfare (MHLW) for Manufacturing and Marketing approval of CABOMETYX in combination with OPDIVO® (nivolumab) for the treatment of patients with unresectable, advanced or metastatic renal cell carcinoma (RCC).
VENCLEXTA® (venetoclax)
OPDIVO® (nivolumab) in Combination with CABOMETYX® (cabozantinib)
OPDIVO® (nivolumab) in Combination with CABOMETYX® (cabozantinib)
VENCLEXTA® (venetoclax) Receives FDA Full Approval for Acute Myeloid Leukemia (AML)
Fri October 16, 2020 7:34 PM|PR Newswire|About: ABBV
- The Phase 3 VIALE-A trial showed that significantly more patients treated with VENCLEXTA in combination with azacitidine achieved complete remission and lived longer versus patients treated with azacitidine alone1
- AML is one of the most aggressive and difficult-to-treat blood cancers with a very low survival rate2,3
- The National Comprehensive Cancer Network (NCCN) guidelines recommend the VENCLEXTA and azacitidine combination as a Category 1 Preferred AML treatment regimen for patients ineligible for intensive chemotherapy4
PR Newswire
NORTH CHICAGO, Ill., Oct. 16, 2020 /PRNewswire/ -- AbbVie (ABBV)
VENCLEXTA® (venetoclax)
Uses
VENCLEXTA is a prescription medicine used:
- to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who:
- are 75 years of age or older, or
- have other medical conditions that prevent the use of standard chemotherapy.
VENCLEXTA was approved based on response rates. Continued approval for this use may depend on the results of an ongoing study to find out how VENCLEXTA works over a longer period of time.
It is not known if VENCLEXTA is safe and effective in children.
For more information, please visit http://www.abbvie.com/oncology.
For more information about AbbVie, please visit us at www.abbvie.com.
View original content:http://www.prnewswire.com/news-releases/venclexta-venetoclax-receives-fda-full-approval-for-acute-myeloid-leukemia-aml-301154267.html
October 16, 2020
VENCLEXTA® (venetoclax) Receives FDA Full Approval for Acute Myeloid Leukemia (AML)
https://seekingalpha.com/symbol/ABBV
Roche announces full FDA approval for Venclexta combinations for acute myeloid leukaemia
- Approval supported by data from phase III confirmatory trials, VIALE-A and VIALE-C
- VIALE-A study showed Venclexta plus azacitidine significantly improved overall survival in newly diagnosed AML compared to azacitidine alone
- Supplemental New Drug Applications approved under the FDA’s Real-Time Oncology Review pilot programme and Project Orbis initiative
Basel, 19 October 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY
https://www.roche.com/media/releases/med-cor-2020-10-19.htm?source=news_body_link
https://seekingalpha.com/symbol/RHHBY
OPDIVO ® (nivolumab)
OPDIVO® (nivolumab) in Combination with CABOMETYX® (cabozantinib)
KEYTRUDA® (pembrolizumab)
Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Opdivo (nivolumab) as Second-Line Treatment for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
Fri October 16, 2020 7:45 AM|Business Wire|About: BMY
Application based on Phase 3 ATTRACTION-3 trial demonstrating a statistically significant and clinically meaningful improvement in patients’ overall survival compared to chemotherapy
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY)
OPDIVO ® (nivolumab)
OPDIVO® Immunotherapy: Giving People a Choice and a Chance Against Their Cancer
ADVANCED LUNG CANCER
NON-SMALL CELL LUNG CANCER
- OPDIVO + YERVOY for certain adults with newly diagnosed advanced non-small cell lung cancer that tests positive for PD-L1
- OPDIVO + YERVOY, in combination with chemotherapy, for adults with newly diagnosed advanced non-small cell lung cancer
- OPDIVO for people who have had prior treatments for non-small cell lung cancer
SMALL CELL LUNG CANCER
Choose your condition:
- Advanced Lung Cancer
- Advanced Kidney Cancer
- Advanced Liver Cancer
- Colorectal Cancer (MSI-H/dMMR)
- Advanced Esophageal Squamous Cell Cancer
- Melanoma
- Head and Neck Squamous Cell Cancer
- Advanced Bladder Cancer
- Classical Hodgkin Lymphoma
Please see U.S. 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/20201016005370/en/
Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Opdivo (nivolumab) as Second-Line Treatment for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
10/16/2020CATEGORY:
Application based on Phase 3 ATTRACTION-3 trial demonstrating a statistically significant and clinically meaningful improvement in patients’ overall survival compared to chemotherapy
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) for the treatment of adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based combination chemotherapy. The European Commission (EC), which is authorized to approve medicines for the European Union (EU), will now review the CHMP recommendation.
https://seekingalpha.com/symbol/BMY
KEYTRUDA® (pembrolizumab)
KEYTRUDA® (pembrolizumab)
KEYTRUDA® (pembrolizumab)
FDA Approves Expanded Indication for Merck’s KEYTRUDA® (pembrolizumab) in Adult Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (cHL)
Thu October 15, 2020 6:45 AM|Business Wire|About: MRK
KEYTRUDA Is the First Anti-PD-1 Therapy Approved for Adult Patients With Relapsed or Refractory cHL After Frontline Therapy
KEYTRUDA Also Approved for Pediatric Patients With Refractory cHL, or cHL That Has Relapsed After Two or More Lines of Therapy
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK),
KEYTRUDA® (pembrolizumab)
A BREAKTHROUGH IMMUNOTHERAPY THAT MAY HELP YOU FACE YOUR CANCER
IT’S TRU. KEYTRUDA.
SELECT A TYPE OF CANCER
- Advanced non–small cell lung cancer
- Melanoma
- Head and neck squamous cell cancer
- High-risk non-muscle invasive bladder cancer (NMIBC)
- Advanced urothelial bladder cancer
- Advanced kidney cancer (RCC)
- Advanced MSI-H/dMMR colorectal cancer
- Microsatellite instability-high cancer (MSI-H/dMMR)
- Classical Hodgkin lymphoma (cHL)
- Advanced gastric cancer
- Advanced cervical cancer
- Primary mediastinal B‑cell lymphoma (PMBCL)
- Advanced liver cancer (HCC)
- Advanced Merkel cell carcinoma
- Advanced esophageal squamous cell carcinoma
- Cutaneous squamous cell carcinoma (cSCC)
https://seekingalpha.com/symbol/MRK
FDA Approves Expanded Indication for Merck’s KEYTRUDA® (pembrolizumab) in Adult Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (cHL)
October 15, 2020 6:45 am EDT
KEYTRUDA Is the First Anti-PD-1 Therapy Approved for Adult Patients With Relapsed or Refractory cHL After Frontline Therapy
KEYTRUDA Also Approved for Pediatric Patients With Refractory cHL, or cHL That Has Relapsed After Two or More Lines of Therapy
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE:MRK)
For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.
More information is available by calling 855-257-3932 or visiting www.merckaccessprogram-keytruda.com.
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20201015005355/en/
Merck Presents Three-Year Survival Data for KEYTRUDA® (pembrolizumab) in Combination With Chemotherapy and Updated Phase 1/2 Data for Investigational Quavonlimab (MK-1308) in Combination With KEYTRUDA in Advanced Non‑Small Cell Lung Cancer
Fri October 16, 2020 2:00 PM|Business Wire|About: MRK
New Long-Term Data From KEYNOTE-021 (Cohort G) Reinforce Use of KEYTRUDA in Certain Patients with Advanced Nonsquamous NSCLC
Updated Data for Quavonlimab (MK-1308), a Novel Investigational Anti-CTLA-4 Antibody, in Combination With KEYTRUDA Were Presented; Phase 3 Study for the Combination Planned in First-Line Advanced NSCLC
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK)
KEYNOTE-021 (Cohort G) study evaluating Merck's (MRK +1.2%) KEYTRUDA in combination with chemotherapy vs. chemotherapy alone, as first-line treatment of nonsquamous non-small cell lung cancer (NSCLC), demonstrated a significant improvement in objective response rates (ORR), progression-free survival (PFS) and a sustained, long-term survival benefit, after four years of median study follow-up.
For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.
For more information, visit www.merck.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20201016005608/en/
Merck Presents Three-Year Survival Data for KEYTRUDA® (pembrolizumab) in Combination With Chemotherapy and Updated Phase 1/2 Data for Investigational Quavonlimab (MK-1308) in Combination With KEYTRUDA in Advanced Non‑Small Cell Lung Cancer
October 16, 2020 2:00 pm EDT
New Long-Term Data From KEYNOTE-021 (Cohort G) Reinforce Use of KEYTRUDA in Certain Patients with Advanced Nonsquamous NSCLC
Updated Data for Quavonlimab (MK-1308), a Novel Investigational Anti-CTLA-4 Antibody, in Combination With KEYTRUDA Were Presented; Phase 3 Study for the Combination Planned in First-Line Advanced NSCLC
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK)
https://seekingalpha.com/symbol/MRK
Dupixent® (dupilumab)
KEYTRUDA® (pembrolizumab)
Dupixent® (dupilumab)
Dupixent® (dupilumab) significantly reduced severe asthma attacks in children and is the only biologic to demonstrate improvement in children’s lung function in a randomized Phase 3 trial
Tue October 13, 2020 1:00 AM|GlobeNewswire|About: SNY
Dupixent® (dupilumab) significantly reduced severe asthma attacks in children and is the only biologic to demonstrate improvement in children’s lung function in a randomized Phase 3 trial
- Data in children aged 6-11 further suggest Dupixent has potential to be best-in-class treatment option
- Dupixent significantly reduced severe asthma attacks by up to 65% over one year compared to placebo
- Significant and rapid improvement in lung function seen within two weeks and sustained for up to 52 weeks
- Results further support well-established safety profile of Dupixent
- U.S. and E.U. regulatory submissions for children aged 6-11 years planned by Q1 2021
PARIS and TARRYTOWN, N.Y. – October 13, 2020
Dupixent® (dupilumab)
please visit www.regeneron.com
https://seekingalpha.com/symbol/SNY
https://seekingalpha.com/symbol/REGN
https://www.regeneron.com/pipeline
October 13, 2020 at 12:59 AM EDT Back
DUPIXENT® (DUPILUMAB) SIGNIFICANTLY REDUCED SEVERE ASTHMA ATTACKS IN CHILDREN AND IS THE ONLY BIOLOGIC TO DEMONSTRATE IMPROVEMENT IN CHILDREN'S LUNG FUNCTION IN A RANDOMIZED PHASE 3 TRIAL
TARRYTOWN, N.Y. and PARIS, Oct. 13, 2020 /PRNewswire/ --
Data in children aged 6-11 further suggest Dupixent has potential to be best-in-class treatment option
Dupixent significantly reduced severe asthma attacks by up to 65% over one year compared to placebo
Significant and rapid improvement in lung function seen within two weeks and sustained for up to 52 weeks
U.S. and EU regulatory submissions for children aged 6-11 years planned by Q1 2021
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi
CHMP recommends approval of Dupixent® (dupilumab) for children aged 6 to 11 years with severe atopic dermatitis
Fri October 16, 2020 8:00 AM|GlobeNewswire|About: SNY
CHMP recommends approval of Dupixent® (dupilumab) for children aged 6 to 11 years with severe atopic dermatitis
- Recommendation based on pivotal trial that showed Dupixent plus topical corticosteroids (TCS) significantly improved measures of overall disease severity, skin clearance, itch and health-related quality of life measures, compared to TCS alone
- Data further reinforce the well-established safety profile of Dupixent in adult and adolescent atopic dermatitis patients
- Dupixent would be the first biologic medicine available in the EU to treat this patient group and remains the only biologic medicine approved in moderate-to-severe atopic dermatitis for adolescents and adults
PARIS and TARRYTOWN, NY – October 16, 2020 – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Dupixent® (dupilumab), recommending to extend the approval in the European Union (EU) to include children aged 6 to 11 years with severe atopic dermatitis who are candidates for systemic therapy.
DUPIXENT® (dupilumab injection) now approved by Health Canada for patients with severe asthma
Tue November 17, 2020 7:00 AM|Canada Newswire
- Only biologic approved in Canada to treat severe asthma with type 2 / eosinophilic phenotype, or oral corticosteroid-dependent asthma
- Fourth indication for DUPIXENT® in Canada following approvals for moderate-to-severe atopic dermatitis in adults and adolescents and severe chronic rhinosinusitis with nasal polyposis (CRSwNP).1
MISSISSAUGA, ON, Nov. 17, 2020 /CNW/ - Sanofi Canada announced today that Health Canada approved a new indication for DUPIXENT® (dupilumab injection), for adults and adolescents aged 12 years and older as an add-on maintenance treatment for severe asthma with a type 2 / eosinophilic phenotype or oral corticosteroid-dependent asthma.2
https://seekingalpha.com/symbol/BMY
OPDIVO ® (nivolumab)
KEYTRUDA® (pembrolizumab)
Dupixent® (dupilumab)
Opdivo (nivolumab) Plus Chemotherapy Shows Statistically Significant Improvement in Pathologic Complete Response as Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer in Phase 3 CheckMate -816 Trial
Wed October 7, 2020 6:59 AM|Business Wire|About: BMY
CheckMate -816 met a primary endpoint of improved pathologic complete response in patients who received Opdivo plus chemotherapy before surgery
Positive results mark the first time an immune checkpoint inhibitor-based combination has demonstrated superior efficacy versus chemotherapy as neoadjuvant therapy in a Phase 3 trial in resectable non-small cell lung cancer
Opdivo-based treatments have now shown benefit in four Phase 3 clinical trials in early-stage cancers, including lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)
Phase 3 clinical trial, CheckMate-816, evaluating the combination of Opdivo (nivolumab) and chemo administered before surgery in patients with resectable non-small cell lung cancer.
OPDIVO ® (nivolumab)
OPDIVO® Immunotherapy: Giving People a Choice and a Chance Against Their Cancer
ADVANCED LUNG CANCER
NON-SMALL CELL LUNG CANCER
- OPDIVO + YERVOY for certain adults with newly diagnosed advanced non-small cell lung cancer that tests positive for PD-L1
- OPDIVO + YERVOY, in combination with chemotherapy, for adults with newly diagnosed advanced non-small cell lung cancer
- OPDIVO for people who have had prior treatments for non-small cell lung cancer
SMALL CELL LUNG CANCER
Choose your condition:
- Advanced Lung Cancer
- Advanced Kidney Cancer
- Advanced Liver Cancer
- Colorectal Cancer (MSI-H/dMMR)
- Advanced Esophageal Squamous Cell Cancer
- Melanoma
- Head and Neck Squamous Cell Cancer
- Advanced Bladder Cancer
- Classical Hodgkin Lymphoma
Opdivo (nivolumab) Plus Chemotherapy Shows Statistically Significant Improvement in Pathologic Complete Response as Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer in Phase 3 CheckMate -816 Trial
10/07/2020CATEGORY:
CheckMate -816 met a primary endpoint of improved pathologic complete response in patients who received Opdivo plus chemotherapy before surgery
Positive results mark the first time an immune checkpoint inhibitor-based combination has demonstrated superior efficacy versus chemotherapy as neoadjuvant therapy in a Phase 3 trial in resectable non-small cell lung cancer
Opdivo-based treatments have now shown benefit in four Phase 3 clinical trials in early-stage cancers, including lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that the Phase 3 CheckMate -816 trial met a primary endpoint of pathologic complete response (pCR) in resectable non-small cell lung cancer (NSCLC). In the trial, significantly more patients treated with Opdivo (nivolumab) plus chemotherapy before surgery showed no evidence of cancer cells in their resected tissue compared to those treated with chemotherapy alone. CheckMate -816 is the first and only Phase 3 trial to demonstrate a benefit with an immune checkpoint inhibitor in combination with chemotherapy as a neoadjuvant treatment in non-metastatic NSCLC.
Please see U.S. Full Prescribing Information for OPDIVO and YERVOY.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201007005273/en/
Veklury® (remdesivir)
Opdivo® (nivolumab) + Yervoy® (ipilimumab)
Opdivo® (nivolumab) + Yervoy® (ipilimumab)
Gilead Sciences Signs Joint Procurement Agreement With the European Commission for Veklury® (remdesivir)
Thu October 8, 2020 3:00 AM|Business Wire|About: GILD
– Agreement Enables Rapid and Equitable Access to the Clinical Benefits of Veklury for Appropriate COVID-19 Patients in the Majority of Countries of the EU and EEA –
– Greatly Expanded Supply of Veklury Expected to Meet European Real-Time Demand and Stockpiling Needs in October –
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences (GILD)
Veklury® (remdesivir)
please review the Fact Sheets and FDA Letter of Authorization available at www.gilead.com/remdesivir.
For more information on Gilead’s response to the coronavirus outbreak, please visit the company’s dedicated page: https://www.gilead.com/purpose/advancing-global-health/covid-19.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201008005332/en/
Gilead Sciences signs joint procurement agreement with EC for remdesivir
Oct. 8, 2020 3:36 AM ET|About: Gilead Sciences, Inc. (GILD)|By: Mamta Mayani, SA News Editor
https://seekingalpha.com/symbol/GILD
Gilead Sciences' remdesivir cuts COVID-19 death risk in patients on low-flow oxygen
by Eric Sagonowsky | Oct 9, 2020 9:13am
October 08, 2020
Gilead Sciences Signs Joint Procurement Agreement With the European Commission for Veklury® (remdesivir)
– Agreement Enables Rapid and Equitable Access to the Clinical Benefits of Veklury for Appropriate COVID-19 Patients in the Majority of Countries of the EU and EEA –
– Greatly Expanded Supply of Veklury Expected to Meet European Real-Time Demand and Stockpiling Needs in October –
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences (Nasdaq: GILD) and the European Commission
Innovation
An Open Letter from Daniel O’Day, Chairman & CEO, Gilead Sciences
Daniel O’Day - October 08, 2020
https://stories.gilead.com/articles/an-open-letter-from-our-chairman-and-ceo-oct-8
Innovation
An Open Letter from Daniel O’Day, Chairman & CEO, Gilead Sciences
Daniel O’Day - October 08, 2020
https://stories.gilead.com/articles/an-open-letter-from-our-chairman-and-ceo-oct-8
Final Results of National Institute of Allergy and Infectious Diseases’ ACTT-1 Trial Published in New England Journal of Medicine Expand Clinical Benefits of Veklury® (remdesivir) for the Treatment of COVID-19
Business WireOctober 8, 2020
Remdesivir for the Treatment of Covid-19 — Final Report
List of authors.
- John H. Beigel, M.D.,
- Kay M. Tomashek, M.D., M.P.H.,
- Lori E. Dodd, Ph.D.,
- Aneesh K. Mehta, M.D.,
- Barry S. Zingman, M.D.,
- Andre C. Kalil, M.D., M.P.H.,
- Elizabeth Hohmann, M.D.,
- Helen Y. Chu, M.D., M.P.H.,
- Annie Luetkemeyer, M.D.,
- Susan Kline, M.D., M.P.H.,
- Diego Lopez de Castilla, M.D., M.P.H.,
- Robert W. Finberg, M.D.,
- et al.,
- for the ACTT-1 Study Group Members*
https://www.nejm.org/doi/full/10.1056/NEJMoa2007764?query=featured_home
Opdivo® (nivolumab) + Yervoy® (ipilimumab)
Opdivo® (nivolumab) + Yervoy® (ipilimumab)
Opdivo® (nivolumab) + Yervoy® (ipilimumab)
U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) as the First and Only Immunotherapy Treatment for Previously Untreated Unresectable Malignant Pleural Mesothelioma
Fri October 2, 2020 4:12 PM|Business Wire|About: BMY
Opdivo + Yervoy is the first new systemic therapy in over 15 years to be approved by the FDA in this setting1,2
Approval is based on CheckMate -743 in which Opdivo + Yervoy demonstrated superior overall survival vs. standard of care chemotherapy1
Approval marks third indication for Opdivo + Yervoy-based treatments in thoracic cancers and seventh indication overall
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)
https://seekingalpha.com/symbol/BMY
For more information about Bristol Myers Squibb, visit us at BMS.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20201002005481/en/
Bristol Myers Squibb Announces Update on CheckMate -915 Evaluating Opdivo (nivolumab) Plus Yervoy (ipilimumab) Versus Opdivo in Resected High-Risk Melanoma Patients
10/02/2020
CATEGORY:
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)
https://www.opdivo.com/about-opdivo/how-the-combination-works-combinationtherapy
U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) as the First and Only Immunotherapy Treatment for Previously Untreated Unresectable Malignant Pleural Mesothelioma
10/02/2020
CATEGORY:
Opdivo + Yervoy is the first new systemic therapy in over 15 years to be approved by the FDA in this setting1,2
Approval is based on CheckMate -743 in which Opdivo + Yervoy demonstrated superior overall survival vs. standard of care chemotherapy1
Approval marks third indication for Opdivo + Yervoy-based treatments in thoracic cancers and seventh indication overall
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)
Farxiga (dapagliflozin)
Opdivo® (nivolumab) + Yervoy® (ipilimumab)
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab)
Farxiga granted Breakthrough Therapy Designation in US for chronic kidney disease
PUBLISHED2 October 2020
2 October 2020 07:00 BST
Designation follows DAPA-CKD Phase III trial results in which Farxiga demonstrated unprecedented reduction in the risk of kidney failure and cardiovascular or renal death in patients with chronic kidney disease
AstraZeneca’s Farxiga nabs accelerated review in U.S. for kidney disease
Oct. 2, 2020 6:44 AM ET|About: AstraZeneca PLC (AZN)|By: Mamta Mayani, SA News Editor
Farxiga (dapagliflozin)
https://seekingalpha.com/symbol/AZN
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab)
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab)
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab)
European Medicines Agency Validates Bristol Myers Squibb’s Type II Variation Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) for First-line Treatment of Malignant Pleural Mesothelioma
Tue September 15, 2020 6:59 AM|Business Wire|About: BMY
Opdivo plus Yervoy would potentially be the first immunotherapy option for the first-line treatment of this cancer with high unmet needs
Application based on positive results from pivotal Phase 3 CheckMate -743 trial
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)
https://seekingalpha.com/symbol/BMY
Please see U.S. Full Prescribing Information for OPDIVO and YERVOY.
European Medicines Agency Validates Bristol Myers Squibb’s Type II Variation Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) for First-line Treatment of Malignant Pleural Mesothelioma
09/15/2020CATEGORY:
Opdivo plus Yervoy would potentially be the first immunotherapy option for the first-line treatment of this cancer with high unmet needs
Application based on positive results from pivotal Phase 3 CheckMate -743 trial
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)
View source version on businesswire.com: https://www.businesswire.com/news/home/20200915005684/en/
IMFINZI® (durvalumab)
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab)
IMBRUVICA® (ibrutinib) in Combination with Rituximab
Imfinzi approved in the EU for the treatment of extensive-stage small cell lung cancer
PUBLISHED1 September 2020
1 September 2020 07:00 BST
Only PD-1/PD-L1 immunotherapy to demonstrate a significant survival benefit and improved response rate in combination with a choice of chemotherapies
AstraZeneca's Imfinzi OK'd in Europe for first-line lung cancer
Sep. 1, 2020 5:56 AM ET|About: AstraZeneca PLC (AZN)|By: Mamta Mayani, SA News Editor
https://seekingalpha.com/news/3610330-astrazenecas-imfinzi-okd-in-europe-for-first-line-lung-cancer
https://seekingalpha.com/symbol/AZN
https://www.imfinzi.com/patient.html
IMBRUVICA® (ibrutinib) in Combination with Rituximab
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab)
IMBRUVICA® (ibrutinib) in Combination with Rituximab
Janssen Announces European Commission Decision for Expanded Use of IMBRUVICA® (ibrutinib) in Combination with Rituximab for Previously Untreated Patients with Chronic Lymphocytic Leukaemia (CLL)
Mon September 7, 2020 4:45 AM|Business Wire|About: JNJ
Patients who were new to CLL treatment lived longer without disease progression with the IMBRUVICA®-based regimen compared to patients treated with a chemo-immunotherapy regimen1
BEERSE, Belgium--(BUSINESS WIRE)-- The Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ)
The primary study results were published previously in The New England Journal of Medicine,
For a full list of side effects and information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics for further information.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200907005149/en/
https://seekingalpha.com/symbol/JNJ
https://seekingalpha.com/symbol/ABBV
https://www.rituxan.com/patient/what-is-rituxan.html
https://seekingalpha.com/symbol/RHHBY
BIOTECNOVA™
Veklury® (Remdesivir)
Tecentriq® (atezolizumab) and bevacizumab combination
Tecentriq® (atezolizumab) and bevacizumab combination
Gilead’s Investigational Antiviral Veklury® (Remdesivir) Receives U.S. Food and Drug Administration Emergency Use Authorization for the Treatment of Patients With Moderate COVID-19
Fri August 28, 2020 4:45 PM|Business Wire|About: GILD
-- Expands Previous Authorization of Veklury to Treat Hospitalized Patients with COVID-19 Regardless of Oxygen Status --
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD)
please review the Fact Sheets and FDA Letter of Authorization available at www.gilead.com/remdesivir.
Gilead Sciences Update On The Company’s Ongoing Response To COVID-19
https://www.gilead.com/purpose/advancing-global-health/covid-19
View source version on businesswire.com: https://www.businesswire.com/news/home/20200828005370/en/
https://seekingalpha.com/symbol/GILD
FDA OKs emergency use of Gilead's remdesivir for moderate COVID-19
Aug. 28, 2020 4:56 PM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W. House, SA News Editor
Remdesivir Emergency Use
Tecentriq® (atezolizumab) and bevacizumab combination
Tecentriq® (atezolizumab) and bevacizumab combination
Tecentriq® (atezolizumab) and bevacizumab combination
Health Canada grants market authorization for Tecentriq® in combination with bevacizumab,[1] the first immunotherapy combination treatment, for the most common form of liver cancer
Wed August 19, 2020 7:00 AM|Canada Newswire
Tecentriq in combination with bevacizumab improved overall survival and progression-free survival compared to the previous standard of care[3]
MISSISSAUGA, ON, Aug. 19, 2020 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) today announced that Health Canada has granted market authorization for Tecentriq (atezolizumab for injection), in combination with bevacizumab, for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who require systemic therapy.[4]
please visit www.RocheCanada.com.
https://seekingalpha.com/symbol/BMY
https://seekingalpha.com/symbol/RHHBY
Imfinzi (durvalumab)
Tecentriq® (atezolizumab) and bevacizumab combination
Imfinzi (durvalumab)
Imfinzi granted FDA Priority Review for less-frequent,
fixed-dose use
PUBLISHED18 August 2020
18 August 2020 07:00 BST
Option would extend dosing to four weeks in non-small cell lung and bladder cancer reducing medical visits by half
AstraZeneca's Imfinzi (durvalumab) has received acceptance for its supplemental Biologics License Application (sBLA) and has also been granted Priority Review in the US for a new four-week, fixed-dose regimen for treatment in the approved indications of non-small cell lung cancer (NSCLC) and bladder cancer.
https://seekingalpha.com/symbol/AZN
https://www.imfinzi.com/stage-3-nsclc.html
Imfinzi approved in Japan for the treatment of extensive-stage small cell lung cancer
PUBLISHED21 August 2020
21 August 2020 07:00 BST
Only PD-1/PD-L1 immunotherapy to demonstrate both a significant survival benefit and improved response rate in combination with a choice of chemotherapies
AstraZeneca’s Imfinzi (durvalumab) has been approved in Japan for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC), in combination with etoposide plus a choice of platinum chemotherapy (either carboplatin or cisplatin). SCLC is a highly aggressive, fast-growing form of lung cancer that typically recurs and progresses rapidly, despite initial response to chemotherapy.1,2
OPDIVO® (nivolumab)
Opdivo® (nivolumab) Plus Yervoy® (ipilimumab)
Imfinzi (durvalumab)
CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival
Tue August 11, 2020 6:59 AM|Business Wire|About: BMY
Opdivo is the first and only treatment to demonstrate superior efficacy in patients with esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy and resection
Second tumor, in addition to melanoma, where Opdivo has demonstrated a benefit in the adjuvant setting
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)
Please see U.S. Full Prescribing Information for OPDIVO and YERVOY
https://www.businesswire.com/news/home/20200811005248/en/
CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival
Opdivo is the first and only treatment to demonstrate superior efficacy in patients with esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy and resection
Second tumor, in addition to melanoma, where Opdivo has demonstrated a benefit in the adjuvant setting
CATEGORY:
CORPORATE/FINANCIAL NEWSTUESDAY, AUGUST 11, 2020 6:59 AM EDT
Bristol Myers' Opdivo successful in two late-stage studies
Aug. 11, 2020 7:31 AM ET|About: Bristol-Myers Squibb C... (BMY)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3603939-bristol-myers-opdivo-successful-in-two-late-stage-studies
CheckMate-577: Opdivo as adjuvant therapy in patients with resected esophageal or gastroesophageal junction (GEJ) cancer.
Aducanumab (BIIB037)
Opdivo® (nivolumab) Plus Yervoy® (ipilimumab)
Opdivo® (nivolumab) Plus Yervoy® (ipilimumab)
FDA Accepts Biogen’s Aducanumab Biologics License Application for Alzheimer's Disease with Priority Review
Fri August 7, 2020 7:30 AM|GlobeNewswire|About: BIIB
- Priority Review accelerates FDA review time, with a Prescription Drug User Fee Act (PDUFA) target action on March 7, 2021
- If approved, aducanumab would be the first treatment to meaningfully change the course of Alzheimer’s disease
CAMBRIDGE, Mass. and TOKYO, Aug. 07, 2020 (GLOBE NEWSWIRE) -- Biogen (BIIB) and Eisai, Co., Ltd. (Tokyo, Japan)
FDA ACCEPTS BIOGEN’S ADUCANUMAB BIOLOGICS LICENSE APPLICATION FOR ALZHEIMER'S DISEASE WITH PRIORITY REVIEW
August 7, 2020 at 7:30 AM EDT
- Priority Review accelerates FDA review time, with a Prescription Drug User Fee Act (PDUFA) target action on March 7, 2021
- If approved, aducanumab would be the first treatment to meaningfully change the course of Alzheimer’s disease
CAMBRIDGE, Mass. and TOKYO, Aug. 07, 2020 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan)
https://www.eisai.com/index.html
https://alzheimersnewstoday.com/aducanumab/
https://www.biogen.com/en_us/home.html
https://seekingalpha.com/symbol/BIIB
Opdivo® (nivolumab) Plus Yervoy® (ipilimumab)
Opdivo® (nivolumab) Plus Yervoy® (ipilimumab)
Opdivo® (nivolumab) Plus Yervoy® (ipilimumab)
Opdivo® (nivolumab) Plus Yervoy® (ipilimumab) Demonstrates Durable Survival Benefit vs. Chemotherapy in Patients with Previously Untreated Malignant Pleural Mesothelioma
Sat August 8, 2020 7:00 AM|Business Wire|About: BMY
https://www.businesswire.com/news/home/20200808005001/en/
Phase 3 clinical trial, CheckMate-743, comparing the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) (O+Y) to platinum-based chemo in patients with unresectable malignant pleural mesothelioma (MPM) in a first-line setting.
Opdivo® (nivolumab) Plus Yervoy® (ipilimumab) Demonstrates Durable Survival Benefit vs. Chemotherapy in Patients with Previously Untreated Malignant Pleural Mesothelioma
CheckMate -743 is the first and only Phase 3 trial in which first-line immunotherapy treatment improved survival in patients with malignant pleural mesothelioma
With these positive results, Opdivo plus Yervoy has now shown clinical benefit in six different tumor types, including durable, superior overall survival vs. chemotherapy in two thoracic cancers
CATEGORY:
CORPORATE/FINANCIAL NEWSSATURDAY, AUGUST 8, 2020 7:00 AM EDT
https://www.opdivohcp.com/home
https://seekingalpha.com/symbol/BMY
KEYTRUDA® (pembrolizumab)
KEYTRUDA® (pembrolizumab)
KEYTRUDA® (pembrolizumab)
Merck Announces Two US Regulatory Milestones for KEYTRUDA® (pembrolizumab) in Triple-Negative Breast Cancer (TNBC)
Thu July 30, 2020 6:45 AM|Business Wire|About: MRK
FDA Grants Priority Review to Supplemental Biologics License Application (sBLA) for KEYTRUDA Plus Chemotherapy for the Treatment of Certain Patients With Metastatic TNBC Based on KEYNOTE-355 Trial
FDA Accepts sBLA for KEYTRUDA for the Treatment of Patients with High-Risk Early-Stage TNBC Based on KEYNOTE-522 Trial
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK)
KEYNOTE-355 is a randomized, double-blinded, Phase 3 trial (ClinicalTrials.gov, NCT02819518) evaluating KEYTRUDA in combination with one of three different chemotherapies (investigator’s choice of nab-paclitaxel, paclitaxel or gemcitabine/carboplatin)
KEYNOTE-522 is a randomized, double-blind, Phase 3 trial (ClinicalTrials.gov, NCT03036488) evaluating KEYTRUDA in combination with chemotherapy compared with placebo plus chemotherapy as neoadjuvant therapy
https://seekingalpha.com/symbol/MRK
https://www.businesswire.com/news/home/20200730005275/en/
Veklury® (Remdesivir)
KEYTRUDA® (pembrolizumab)
KEYTRUDA® (pembrolizumab)
Health Canada Grants Marketing Authorization with Conditions (NOC/c) for Gilead's Veklury® (Remdesivir) for the Treatment of Coronavirus Disease 2019 (COVID-19)
Tue July 28, 2020 10:30 AM|Canada Newswire
-- Veklury is the First Approved Treatment Option for COVID-19 in Canada --
MISSISSAUGA, ON, July 28, 2020 /CNW/ - Gilead Sciences Canada, Inc.
For more information about Gilead Sciences, visit the company's website at www.gilead.com
https://seekingalpha.com/symbol/GILD
https://www.gilead.com/purpose/advancing-global-health/covid-19
https://www.gilead.com/purpose/advancing-global-health/covid-19
Farxiga (dapagliflozin)
KEYTRUDA® (pembrolizumab)
CALQUENCE® (acalabrutinib) capsules
Farxiga met all primary and secondary endpoints in groundbreaking Phase III DAPA-CKD trial for the treatment of patients with chronic kidney disease
PUBLISHED28 July 2020
This announcement contains inside information
28 July 2020 07:00 BST
Farxiga significantly reduced the worsening of renal function or risk of death in patients with chronic kidney disease with and without type-2 diabetes
AstraZeneca's Farxiga successful in late-stage kidney disease study
Jul. 28, 2020 6:50 AM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Editor
Phase 3 clinical trial, DAPA-CKD, evaluating the effect of Farxiga (dapagliflozin) on renal outcomes and cardiovascular mortality in chronic kidney disease (CKD) patients with and without type 2 diabetes (T2D).
https://seekingalpha.com/symbol/AZN
CALQUENCE® (acalabrutinib) capsules
IMBRUVICA® (ibrutinib) in Combination with Rituximab
CALQUENCE® (acalabrutinib) capsules
European advisory group backs AstraZeneca's Calquence for leukemia treatment
Jul. 24, 2020 10:54 AM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Editor
Calquence
acalabrutinib
On 23 July 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Calquence,1 intended for the treatment of chronic lymphocytic leukaemia (CLL). The applicant for this medicinal product is AstraZeneca AB.
https://www.ema.europa.eu/en/medicines/human/summaries-opinion/calquence
Please see full Prescribing Information, including Patient Information
https://seekingalpha.com/symbol/AZN