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VENCLEXTA®/ VENCLYXTO® (venetoclax)

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Venclexta-based Treatments in Chronic Lymphocytic Leukemia Sun December 8, 2019 7:30 AM RHHBY

 

New Long-Term Data Continues to Demonstrate Progression-Free Survival and Overall Survival Benefits with VENCLEXTA®/ VENCLYXTO® (venetoclax) Combination in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)

- Four-year updated analysis from the MURANO trial showed an 81% reduction in the risk of disease progression or death in patients treated with VENCLEXTA®/VENCLYXTO® (venetoclax) plus rituximab (VenR) and higher rates of minimal residual disease (MRD)-negativity compared to bendamustine plus rituximab (BR)[1]

- The risk of death was decreased by 59% in the 130 patients who completed VenR, versus BR, despite 79% of patients in the BR arm who went on to receive a novel targeted treatment. Median overall survival (OS) was not reached for either treatment group[1]

- Sixty-eight percent of the 130 patients who completed the treatment course were free of disease progression and maintained OS benefit 24-months after being off therapy[1]

- Full results are being highlighted today in an oral presentation at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition

NEWS PROVIDED BY

AbbVie 

Dec 08, 2019, 07:30 ET

NORTH CHICAGO, Ill., Dec. 8, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV)

 https://www.prnewswire.com/news-releases/new-long-term-data-continues-to-demonstrate-progression-free-survival-and-overall-survival-benefits-with-venclexta-venclyxto-venetoclax-combination-in-patients-with-relapsedrefractory-chronic-lymphocytic-leukemia-cll-300971015.html 


 https://www.abbvie.com/our-science/therapeutic-focus-areas/oncology.html 


 GAZYVA® (obinutuzumab) is a prescription medicine used in combination with chemotherapy, followed by GAZYVA alone in those who responded, to treat stage II bulky, III or IV follicular lymphoma (FL) in adults who have not had previous FL treatment.

GAZYVA® (obinutuzumab) is a prescription medicine used with the chemotherapy drug, bendamustine, followed by GAZYVA alone for follicular lymphoma (FL) in adults who did not respond to a rituximab-containing regimen, or whose FL returned after such treatment.

GAZYVA® (obinutuzumab) is a prescription medicine used with the chemotherapy drug, chlorambucil, to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment. 

 https://www.gazyva.com/ 


Venclexta-based Treatments in Chronic Lymphocytic Leukemia

 

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.

 https://www.venclexta.com/ 


 

Rituxan is a prescription medicine used to treat adults with:

  • Non-Hodgkin’s Lymphoma (NHL): alone or with other chemotherapy medicines.
  • Chronic Lymphocytic Leukemia (CLL): with the chemotherapy medicines fludarabine and cyclophosphamide.
  • Rheumatoid arthritis (RA): with another prescription medicine called methotrexate, to reduce the signs and symptoms of moderate to severe active RA in adults, after treatment with at least one other medicine called a tumor necrosis factor (TNF) antagonist has been used and did not work well enough.
  • Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA): with glucocorticoids.
  • Pemphigus Vulgaris (PV): to treat moderate to severe PV.

 https://www.rituxan.com/ 

VENCLYXTO® (venetoclax) in combination with obinutuzumab

 

AbbVie Receives European Commission Approval of VENCLYXTO® Combination Regimen for Patients with Previously-Untreated Chronic Lymphocytic Leukemia

- VENCLYXTO® plus obinutuzumab is the first chemotherapy-free, fixed-duration combination regimen approved by the European Commission (EC) for patients with previously untreated chronic lymphocytic leukemia (CLL)

- Approval is based on data from the Phase 3 CLL14 trial, which showed that patients treated with obinutuzumab plus one year of treatment with VENCLYXTO had superior progression-free survival (PFS) and higher rates of undetectable minimal residual disease compared to patients receiving a standard of care chemoimmunotherapy regimen of obinutuzumab and chlorambucil[1],[5]

 https://www.prnewswire.com/news-releases/abbvie-receives-european-commission-approval-of-venclyxto-combination-regimen-for-patients-with-previously-untreated-chronic-lymphocytic-leukemia-301021997.html 

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XTANDI® (enzalutamide)

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XTANDI® (enzalutamide)

 

Astellas Announces the Approval of XTANDI® (enzalutamide) by the China National Medical Products Administration (NMPA)

Mon November 25, 2019 7:00 PM|PR Newswire|About: ALPMY, PFE 


 https://www.prnewswire.com/news-releases/astellas-announces-the-approval-of-xtandi-enzalutamide-by-the-china-national-medical-products-administration-nmpa-300964935.html 


 Prostate Cancer Trusted Information to Help Manage Your Care from  


 

Astellas Announces the Approval of XTANDI® (enzalutamide) by the China National Medical Products Administration (NMPA) Approval based on Asian PREVAIL study of men with metastatic castration-resistant prostate cancer

Nov 26, 2019

TOKYO, November 26, 2019 – Astellas Pharma Inc. (TSE: 4503,

 https://www.astellas.com/en/news/15446 

 https://www.cancer.net/sites/cancer.net/files/asco_answers_guide_prostate.pdf 

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VUMERITY™ (diroximel fumarate)

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VUMERITY™ (diroximel fumarate)

 

Biogen Presents Data Demonstrating Improved Gastrointestinal Tolerability With VUMERITY™ (diroximel fumarate) Compared to TECFIDERA® (dimethyl fumarate)

Fri November 22, 2019 7:30 AM|GlobeNewswire|About: BIIB

CAMBRIDGE, Mass., Nov. 22, 2019 (GLOBE NEWSWIRE) -- Biogen Inc. (BIIB) (Nasdaq: BIIB) 


 https://www.vumerity.com/content/dam/commercial/vumerity/pat/en_us/pdf/vumerity-prescribing-information.pdf 


 https://www.biogen.com/ 


 https://seekingalpha.com/news/3521496-biogens-ms-drug-shows-improved-gi-tolerability-vs-tecfidera 


 

BIOGEN PRESENTS DATA DEMONSTRATING IMPROVED GASTROINTESTINAL TOLERABILITY WITH VUMERITY™ (DIROXIMEL FUMARATE) COMPARED TO TECFIDERA® (DIMETHYL FUMARATE)

November 22, 2019 at 7:30 AM EST

CAMBRIDGE, Mass., Nov. 22, 2019 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB)

 http://investors.biogen.com/news-releases/news-release-details/biogen-presents-data-demonstrating-improved-gastrointestinal 

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Ibrutinib (IMBRUVICA®) plus venetoclax (VENCLEXTA®/ VENCLYX

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Ibrutinib (IMBRUVICA®) plus venetoclax (VENCLEXTA®/ VENCLYXTO®)

 November 21, 2019

AbbVie to Present Latest Clinical Research in the Treatment of Leukemias, Lymphomas and Other Blood Cancers at 2019 ASH Annual Meeting

 - AbbVie will present more than 40 abstracts featuring data from approved and investigational medicines
- New minimal residual disease (MRD) data from CAPTIVATE clinical trial evaluating ibrutinib (IMBRUVICA®) plus venetoclax (VENCLEXTA®/ VENCLYXTO®) in first-line treatment chronic lymphocytic leukemia (CLL) will be featured during the CLL Therapy Oral Session (abstract #35)
- Latest data from the ECOG-ACRIN Cancer Research Group-led Phase 3 E1912 study of ibrutinib in combination with rituximab, which served as the basis of a recent FDA sNDA submission, will be presented during the CLL Therapy Oral Session (Abstract #33)
- New long-term data from the MURANO trial evaluating continued benefit with fixed duration venetoclax plus rituximab in patients with relapsed/refractory (R/R) CLL will also be featured in the CLL Therapy Oral Session (abstract #355)

NORTH CHICAGO, Ill., Nov. 21, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that more than 40 abstracts, including 18 oral presentations, will be presented during the upcoming American Society of Hematology (ASH) Annual Meeting & Exposition, December 7-10, in Orlando, FL. New data include presentations on Ibrutinib (IMBRUVICA®) plus venetoclax (VENCLEXTA®/ VENCLYXTO®) among others.

ibrutinib (IMBRUVICA®) plus venetoclax (VENCLEXTA®/ VENCLYXTO®) chronic lymphocytic leukemia (CLL)

 

AbbVie to Present Latest Clinical Research in the Treatment of Leukemias, Lymphomas and Other Blood Cancers at 2019 ASH Annual Meeting

- AbbVie will present more than 40 abstracts featuring data from approved and investigational medicines

- New minimal residual disease (MRD) data from CAPTIVATE clinical trial evaluating ibrutinib (IMBRUVICA®) plus venetoclax (VENCLEXTA®/ VENCLYXTO®) in first-line treatment chronic lymphocytic leukemia (CLL) will be featured during the CLL Therapy Oral Session (abstract #35)

- Latest data from the ECOG-ACRIN Cancer Research Group-led Phase 3 E1912 study of ibrutinib in combination with rituximab, which served as the basis of a recent FDA sNDA submission, will be presented during the CLL Therapy Oral Session (Abstract #33)

- New long-term data from the MURANO trial evaluating continued benefit with fixed duration venetoclax plus rituximab in patients with relapsed/refractory (R/R) CLL will also be featured in the CLL Therapy Oral Session (abstract #355)


 https://www.prnewswire.com/news-releases/abbvie-to-present-latest-clinical-research-in-the-treatment-of-leukemias-lymphomas-and-other-blood-cancers-at-2019-ash-annual-meeting-300962704.html 

Ibrutinib (IMBRUVICA®)

 

Ibrutinib (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 multiple and spread.1,2 By blocking BTK, IMBRUVICA may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs.3

VENCLEXTA®/VENCLYXTO® (venetoclax)

 

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.

 

IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Data Show High Rates of Disease Clearance in Previously Untreated Patients with Chronic Lymphocytic Leukemia (CLL)

- New results from the Phase 2 CAPTIVATE clinical trial show the potential of this fixed-duration, combination therapy for CLL patients starting treatment for the first time

- Data will be presented at an oral presentation session at the 2019 American Society of Hematology (ASH) Annual Meeting (abstract #35)

NEWS PROVIDED BY

AbbVie 

Dec 07, 2019, 07:30 ET

 https://www.prnewswire.com/news-releases/imbruvica-ibrutinib-plus-venclextavenclyxto-venetoclax-combination-data-show-high-rates-of-disease-clearance-in-previously-untreated-patients-with-chronic-lymphocytic-leukemia-cll-300970907.html 


 https://imbruvica.com/ 


 https://www.venclexta.com/?c=ABV_ppc_ppd_cll_br_ggl_5612&cpcd=gdc-1684e83d0eb 

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REVLIMID® (lenalidomide) in combination with rituximab (R²

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REVLIMID® (lenalidomide) in combination with rituximab (R²)

 

INDICATIONS

  • REVLIMID is a prescription medicine used to treat adults with follicular lymphoma (FL) or marginal zone lymphoma (MZL) in combination with a rituximab product, and who have previously been treated for their FL or MZL
  • FL and MZL are types of cancer of white blood cells called B-cell lymphocytes that are found in the lymph nodes and spleen
  • REVLIMID should not be used to treat people who have chronic lymphocytic leukemia (CLL) unless they are participants in a controlled clinical trial
  • It is not known if REVLIMID is safe and effective in children
  • REVLIMID is only available through a restricted distribution program, REVLIMID REMS®

Revlimid® (lenalidomide) in Combination with Rituximab

 

Bristol-Myers Squibb Receives European Commission Approval for Revlimid® (lenalidomide) in Combination with Rituximab for the Treatment of Adult Patients with Previously Treated Follicular Lymphoma

Revlimid plus rituximab is the first chemotherapy-free combination regimen approved in Europe for patients with follicular lymphoma who have relapsed or did not respond to previous treatment

Approval was based on data from the phase 3 AUGMENT study, which showed statistically significant improvements in median progression-free survival in patients treated with the combination over rituximab-placebo monotherapy

 https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-receives-european-commission-approval-rev 


 https://www.celgeneriskmanagement.com/REMSPortal/rems/portal/REMSPortal.portal 


 https://www.revlimid.com/ 


 https://www.rituxan.com/ 

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ERVEBO®

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Merck’s ERVEBO® [Ebola Zaire Vaccine Granted Conditional Approval in the European Union

 KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada  

European Commission has granted a conditional marketing authorization to ERVEBO for active immunization of individuals 18 years of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire Ebola virus 

Ervebo

 Since the middle of last year, the Congo Ebola outbreak has killed more than 2,100 people, making it the second-largest Ebola outbreak in history, after the 2013-16 epidemic in West Africa that killed more than 11,300. 


 

ERVEBO® (Ebola Zaire Vaccine, Live) Now Registered in Four African Countries, Within 90 Days of Reference Country Approval and WHO Prequalification

Fri February 14, 2020 11:20 AM|Business Wire|About: MRK

Democratic Republic of the Congo One of the First African Countries to Register ERVEBO

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK)

 https://seekingalpha.com/pr/17780079-ervebo-ebola-zaire-vaccine-live-now-registered-in-four-african-countries-within-90-days-of 


 https://www.mrknewsroom.com/news-release/ebola/ervebo-ebola-zaire-vaccine-live-now-registered-four-african-countries-within-90-d 


 STN: 125690
Proper Name: Ebola Zaire Vaccine, Live
Tradename: ERVEBO
Manufacturer: Merck Sharp & Dohme Corp.
Indication:

  • Indicated for the prevention of disease caused by Zaire ebolavirus in individuals 18 years of age and older.

 https://www.fda.gov/vaccines-blood-biologics/ervebo 


First FDA-approved vaccine for the prevention of Ebola virus disease

Home/Emergencies/Diseases/Ebola/Ebola health update - DRC, 2019

KEYTRUDA® (pembrolizumab) KEYTRUDA® +LENVIMA® (lenvatinib

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KEYTRUDA® (pembrolizumab)= Metastatic or Unresectable Recurrent Head & Neck Squamous Cell Carcinoma

  

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Patients With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer With Carcinoma In Situ With or Without Papillary Tumors Who Are Ineligible for or Have Elected Not to Undergo Cystectomy

KEYTRUDA Is the First Anti-PD-1 Therapy Approved for Certain Patients With High-Risk, Non-Muscle Invasive Bladder Cancer

Wednesday, January 8, 2020 4:31 pm EST 

 https://www.mrknewsroom.com/news-release/oncology/fda-approves-mercks-keytruda-pembrolizumab-patients-bcg-unresponsive-high-risk 


 https://www.merckaccessprogram-keytruda.com/hcc/ 


Merck Receives Positive EU CHMP Opinion for Two New Regimens of KEYTRUDA® (pembrolizumab) as First-Line Treatment for Metastatic or Unresectable Recurrent Head and Neck Squamous Cell Carcinoma

Opinion Supports Use of KEYTRUDA, as Monotherapy or in Combination with Platinum and 5-Fluorouracil Chemotherapy, in Patients Whose Tumors Express PD-L (CPS ≥1)

October 18, 2019 07:00 AM Eastern Daylight Time

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada
https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf
https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf
https://www.merck.com/clinical-trials/index.htm 


 

FDA Oncologic Drugs Advisory Committee (ODAC) Recommends KEYTRUDA® (pembrolizumab) for the Treatment of Certain Patients with High-Risk, Non-Muscle Invasive Bladder Cancer (NMIBC)

Tue December 17, 2019 5:15 PM|Business Wire|About: MRK 

 https://seekingalpha.com/pr/17731041-fda-oncologic-drugs-advisory-committee-odac-recommends-keytruda-pembrolizumab-for-treatment 


 https://clinicaltrials.gov/ct2/show/NCT02625961 


 https://www.keytruda.com/ 


 

FDA Oncologic Drugs Advisory Committee (ODAC) Recommends KEYTRUDA® (pembrolizumab) for the Treatment of Certain Patients with High-Risk, Non-Muscle Invasive Bladder Cancer (NMIBC)

Tuesday, December 17, 2019 5:15 pm EST
 https://www.mrknewsroom.com/news-release/oncology/fda-oncologic-drugs-advisory-committee-odac-recommends-keytruda-pembrolizumab- 

 

European Commission Approves Two New Regimens of Merck’s KEYTRUDA® (pembrolizumab) as First-Line Treatment for Metastatic or Unresectable Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

KEYTRUDA is the First Anti-PD-1 Therapy Approved in Europe for the First-Line Treatment of Head and Neck Cancer as Monotherapy or in Combination with Chemotherapy, in Patients Whose Tumors Express PD-L1 (CPS ≥1)Approval Based on Significant Overall Survival Findings from Phase 3 KEYNOTE-048 TrialNovember 20, 2019 06:45 AM Eastern Standard TimeKENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada 


https://www.businesswire.com/news/home/20191120005267/en/ 


https://www.merck.com/research/index.html#IntroVideo 


https://www.merck.com/clinical-trials/index.html 


https://www.keytruda.com/ 


https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.p 

 

European Commission Approves Two New Regimens of Merck’s KEYTRUDA® (pembrolizumab) as First-Line Treatment for Metastatic or Unresectable Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

Wed November 20, 2019 6:45 AM|Business Wire|About: MRK 

 https://seekingalpha.com/pr/17705201-european-commission-approves-two-new-regimens-merck-s-keytruda-pembrolizumab-first-line 


KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib)

 

FDA Approves KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib) Combination Treatment for Patients with Certain Types of Endometrial Carcinoma

 http://www.lenvima.com/hcp/ 

 

FDA Approves LENVIMA® (lenvatinib) plus KEYTRUDA® (pembrolizumab) Combination Treatment for Patients with Certain Types of Endometrial Carcinoma


 https://www.eisai.com/news/2019/news201967.html 


 https://site-search.eisai.co.jp/eng/?ref=https%3A%2F%2Fwww.eisai.com%2Findex.html&kw=LENVIMA&ie=u&temp=en&sort=s&cond[]=all&pdf=on&by=js 


 https://www.eisai.com/index.html 


 

FDA Grants Priority Review to Merck’s Supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab) in Certain Patients with High-Risk, Non-Muscle Invasive Bladder Cancer (NMIBC)

Mon December 2, 2019 6:45 AM|Business Wire|About: MRK 

 https://seekingalpha.com/pr/17714311-fda-grants-priority-review-merck-s-supplemental-biologics-license-application-sbla-keytruda 


 https://www.businesswire.com/news/home/20191202005300/en/ 


 https://clinicaltrials.gov/ct2/show/NCT02625961 

Keytruda Set to Become World’s Top-Selling Drug,

 

Keytruda Approvals: A Timeline

Published: Aug 13, 2019 By Alex Keown

 https://www.biospace.com/article/keytruda-approvals-a-timeline/ 

Marks First Approval for KEYTRUDA in SCLC

 

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) as Monotherapy for Patients with Metastatic Small Cell Lung Cancer (SCLC) with Disease Progression on or After Platinum-Based Chemotherapy and at Least One Other Prior Line of Therapy

Opdivo (nivolumab) OPDIVO + YERVOY® (ipilimumab)

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European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab)

 Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Opdivo (nivolumab) Four-Week Dosing Schedule for the Adjuvant Treatment of Adult Patients with Melanoma with Involvement of Lymph Nodes or Metastatic Disease


 https://www.businesswire.com/news/home/20190924005279/en/ 


 https://www.bms.com/search-results.html?q=Opdivo 


 https://www.bms.com/ 

 

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) for Patients with Hepatocellular Carcinoma (HCC) Previously Treated with Sorafenib

Wed March 11, 2020 6:59 AM|Business Wire|About: BMY

Opdivo + Yervoy is the first and only dual immunotherapy approved in this setting

Approval based on CheckMate -040 trial in which Opdivo + Yervoy showed an overall response rate of 33% (16/49; 95% CI: 20-48) in this patient population1

Opdivo + Yervoy combination is now approved to treat four types of cancer

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb Company (NYSE: BMY)

 https://seekingalpha.com/pr/17805948-u-s-food-and-drug-administration-approves-opdivo-nivolumab-yervoy-ipilimumab-for-patients 


  PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) 

U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combination for Patients with Previously Treated Advanced Hepatocellular Carcinoma

The FDA also granted Opdivo plus Yervoy Breakthrough Therapy Designation for this potential indication

CATEGORY: 

CORPORATE/FINANCIAL NEWSMONDAY, NOVEMBER 11, 2019 6:59 AM EST 

 https://news.bms.com/press-release/corporatefinancial-news/us-food-and-drug-administration-accepts-priority-review-bris-0 

Data exploring potential of Opdivo & Opdivo plus Yervoy in esophageal, cervical and prostate cancer

 

CheckMate -9LA, a Phase 3 Trial Evaluating Opdivo (nivolumab) Plus Low-Dose Yervoy (ipilimumab) Combined with Chemotherapy, Meets Primary Endpoint Demonstrating Superior Overall Survival Compared to Chemotherapy Alone in First-Line Lung Cancer

Tue October 22, 2019 6:59 AM|Business Wire|About: BMY 


 https://www.businesswire.com/news/home/20191022005425/en/ 


 https://packageinserts.bms.com/pi/pi_yervoy.pdf 


 https://packageinserts.bms.com/pi/pi_opdivo.pdf 


 https://seekingalpha.com/pr/17669553-checkmate-minus-9la-phase-3-trial-evaluating-opdivo-nivolumab-plus-low-dose-yervoy-ipilimumab  


 https://www.opdivohcp.com/home 



Bristol-Myers Squibb Research at ESMO Demonstrates Breadth of Oncology Development Program and Focus on Improving Overall Survival Across Multiple Cancers


 https://www.businesswire.com/news/home/20190919005148/en/ 


 https://www.opdivohcp.com/home 



Opdivo (nivolumab)

 

Bristol-Myers Squibb Announces Pooled Five-Year Survival Results for Opdivo (nivolumab) in Previously-Treated Advanced Non-Small Cell Lung Cancer Patients


 https://www.businesswire.com/news/home/20190910005328/en/ 


 https://www.opdivo.com/ 


 

Japan Ministry of Health, Labor and Welfare Approves Opdivo (nivolumab) for the Treatment of Patients with Unresectable Advanced or Recurrent Esophageal Cancer

Fri February 21, 2020 6:59 AM|Business Wire|About: BMY

First approval of Opdivo for treatment of advanced esophageal cancer

First Immuno-Oncology treatment option approved for patients with esophageal cancer in Japan

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (BMY)

 https://seekingalpha.com/pr/17786523-japan-ministry-of-health-labor-and-welfare-approves-opdivo-nivolumab-for-treatment-of 

European Commission Approves Opdivo (nivolumab)

 

European Commission Approves Opdivo (nivolumab) Four-Week Dosing Schedule for the Adjuvant Treatment of Adult Patients with Melanoma with Involvement of Lymph Nodes or Metastatic Disease Who Have Undergone Complete Resection

Thu October 24, 2019 6:59 AM|Business Wire|About: BMY

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (BMY)


 https://seekingalpha.com/pr/17673364-european-commission-approves-opdivo-nivolumab-four-week-dosing-schedule-adjuvant-treatment  


 https://news.bms.com/press-release/corporatefinancial-news/european-commission-approves-opdivo-nivolumab-four-week-dosing 


 https://news.bms.com/press-release/corporatefinancial-news/european-commission-approves-opdivo-nivolumab-four-week-dosing 


 https://www.opdivo.com/ 


YERVOY® (ipilimumab) is a prescription medicine used in adults and children 12 years of age and older to treat melanoma (a kind of skin cancer) that has spread (metastatic) or cannot be removed by surgery (unresectable).

It is not known if YERVOY is safe and effective in children less than 12 years of age.

YERVOY® (ipilimumab) is a prescription medicine used in adults to help prevent melanoma (a kind of skin cancer) from coming back after it and lymph nodes that contain cancer have been removed by surgery.

It is not known if YERVOY is safe and effective in children.

YERVOY will not work for every patient. Individual results may vary.

BRAFTOVI® (Encorafenib), MEKTOVI® (Binimetinib) & Cetuxima

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BRAFTOVI® (Encorafenib), MEKTOVI® (Binimetinib) and Cetuximab

 

PFIZER PRESENTS INTERIM ANALYSIS RESULTS FROM PHASE 3 BEACON CRC TRIAL OF BRAFTOVI® (ENCORAFENIB), MEKTOVI® (BINIMETINIB) AND CETUXIMAB FOR THE TREATMENT OF BRAFV600E-MUTANT METASTATIC COLORECTAL CANCER


 https://www.businesswire.com/news/home/20190929005046/en/ 

 https://seekingalpha.com/pr/17646946-pfizer-presents-interim-analysis-results-phase-3-beacon-crc-trial-braftovi-encorafenib 

 https://www.arraybiopharma.com/documents/Mektovi_Prescribing_information.pdf 

 https://www.arraybiopharma.com/documents/Braftovi_Prescribing_information.pdf 

BRAFTOVI® (encorafenib) in Combination with ERBITUX® (cetuximab) (BRAFTOVI Doublet)

 

U.S. FDA Accepts and Grants Priority Review to sNDA for BRAFTOVI® (encorafenib) in Combination with ERBITUX® (cetuximab) (BRAFTOVI Doublet) for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer After Prior Therapy

December 18, 2019 10:30 AM Eastern Standard Time

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE)

 https://www.businesswire.com/news/home/20191218005517/en/ 


 https://www.arraybiopharma.com/documents/Braftovi_Prescribing_information.pdf 

 

What is BRAFTOVI + MEKTOVI?

BRAFTOVI and MEKTOVI are prescription medicines used together to treat people with a type of skin cancer called melanoma:

  • that has spread to other parts of the body or cannot be removed by surgery, and
  • that has a certain type of abnormal “BRAF” gene

BRAFTOVI should not be used to treat people with wild-type BRAF melanoma. Your healthcare provider will perform a test to make sure that BRAFTOVI + MEKTOVI is right for you. It is not known if BRAFTOVI or MEKTOVI is safe and effective in children.

 https://www.braftovimektovi.com/ 


 

ERBITUX is an approved treatment for people with certain advanced colorectal and head and neck cancers.

 https://www.erbitux.com/ 

IMBRUVICA® (ibrutinib)

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Phase 3 study of ibrutinib (IMBRUVICA®) in untreated (treatment-naïve) diffuse large B-cell lympho

 The ibrutinib clinical program is designed to fully explore the potential of this first-in-class molecule as a single or combination therapy for multiple cancers and other diseases. Fourteen Phase 3 company-sponsored studies are ongoing. 


 

Extended Follow-up Phase 3 Data Underscore Sustained Efficacy and Safety of IMBRUVICA® (ibrutinib) in the Treatment of Chronic Lymphocytic Leukemia (CLL)

Sat December 7, 2019 7:33 AM|PR Newswire|About: ABBV

- New integrated analysis of up to six years of follow-up from RESONATE™ and RESONATE-2 studies (abstract #3054) demonstrated improved results with earlier IMBRUVICA use in CLL patients new to treatment

- Data featured at the 2019 American Society of Hematology (ASH) Annual Meeting further supports IMBRUVICA as the most comprehensively studied Bruton's tyrosine kinase inhibitor, with 10 FDA approvals and 170,000 patients treated worldwide

PR Newswire

NORTH CHICAGO, Ill., Dec. 7, 2019 /PRNewswire/ -- AbbVie (ABBV)

 https://seekingalpha.com/pr/17721323-extended-follow-up-phase-3-data-underscore-sustained-efficacy-and-safety-of-imbruvica 


IMBRUVICA® (ibrutinib)

 

- Nearly half of all R/R MCL patients in the pooled analysis were able to survive their disease at three years and more than one quarter of patients had no progression in their disease
- Median PFS outcomes were observed to be higher in patients who received ibrutinib earlier and after only one prior therapy
- This analysis comprises of 3.5 years of R/R MCL follow-up data, the longest to date in Bruton's tyrosine kinase (BTK) inhibition
- This press release corresponds to abstract #151


 https://www.nejm.org/doi/full/10.1056/NEJMoa1306220#t=article 


 https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00667-4/fulltext 

U.S. FDA Approval of IMBRUVICA® (ibrutinib) Plus Obinutuzumab (GAZYVA®)

 - Milestone marks the 10th FDA approval for IMBRUVICA in six different disease areas since 2013
- FDA approval is based on positive Phase 3 iLLUMINATE (PCYC-1130) study results, which demonstrated IMBRUVICA plus obinutuzumab significantly prolonged progression-free survival versus the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines Category 1 treatment of chlorambucil plus obinutuzumab
- FDA also approved an updated IMBRUVICA label to include additional long-term efficacy data

NORTH CHICAGO, Ill., Jan. 28, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV),


 https://www.hematology.org/Patients/Cancers/Leukemia.aspx 


 https://www.leukaemia.org.au/disease-information/lymphomas/non-hodgkin-lymphoma/other-non-hodgkin-lymphomas/small-lymphocytic-lymphoma/ 


 https://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency 


 https://www.gazyva.com/ 

IMBRUVICA® (ibrutinib) Combination Regimen

 
- Results from this interim analysis showed ibrutinib plus rituximab prolonged progression-free survival (PFS) compared to a standard chemoimmunotherapy regimen of fludarabine, cyclophosphamide and rituximab (FCR) at nearly 3 years of follow-up (abstract #LBA-4)
- The data also showed an improved overall survival (OS) for CLL patients treated with IMBRUVICA plus rituximab versus FCR
- First head-to-head trial of an IMBRUVICA-based, chemotherapy-free combination regimen versus FCR and dedicated to CLL patients aged 70 years or younger
- Study results were presented at the Late Breaking session at ASH 2018

NORTH CHICAGO, Ill., Dec. 4, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV)

Tecentriq® (atezolizumab) Tecentriq® +Avastin® (bevacizumab

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Tecentriq in Combination With Avastin Increased Overall Survival

 

Genentech Presents Pivotal Data Demonstrating Tecentriq in Combination With Avastin Improves Overall Survival in People With the Most Common Form of Liver Cancer

– First Phase III cancer immunotherapy study to show an improvement in overall survival and progression-free survival in people with unresectable hepatocellular carcinoma compared with sorafenib –

– Results will be presented in the Presidential session at the European Society for Medical Oncology (ESMO) Asia Congress 2019

November 22, 2019 11:05 AM Eastern Standard Time

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY

 https://www.businesswire.com/news/home/20191122005376/en/ 


 https://www.gene.com/ 


 https://www.gene.com/topics/cancer-immunotherapy 


 https://www.avastin.com/ 


 https://www.tecentriq.com/  


 https://seekingalpha.com/pr/17708936-genentech-presents-pivotal-data-demonstrating-tecentriq-combination-avastin-improves-overall 


 China National Medical Products Administration grants approval of Roche’s Tecentriq in combination with chemotherapy as first-line treatment of people with extensive-stage small cell lung cancer

  • This marks the first approval for a Tecentriq-based therapy in China, less than a year after the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals in this indication
  • Tecentriq with chemotherapy (carboplatin and etoposide) is the first and only cancer immunotherapy combination approved for the initial treatment of extensive-stage small cell lung cancer (ES-SCLC)
  • The combination significantly improved overall survival (OS) and progression-free survival (PFS) for the first time in over 20 years

Basel, 14 February 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) 

 https://www.roche.com/media/releases/med-cor-2020-02-14.htm 


Genentech’s Tecentriq in Combination With Avastin Increased Overall Survival and Progression-free Survival in People With Unresectable Hepatocellular Carcinoma


 https://www.businesswire.com/news/home/20191020005095/en/ 


 https://www.gene.com/media/press-releases/14818/2019-10-20/genentechs-tecentriq-in-combination-with 


 https://www.tecentriq.com/ 


 https://www.avastin.com/ 


 https://www.gene.com/topics/cancer-immunotherapy 


 https://www.tecentriq-hcp.com/ 


 

Genentech Submits Supplemental Biologics License Application to the FDA for Tecentriq in Combination With Avastin for the Most Common Form of Liver Cancer

Mon January 27, 2020 1:00 AM|Business Wire|About: RHHBY

– Application is being reviewed under FDA's Real-Time Oncology Review pilot program –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)


 https://www.gene.com/media/press-releases/14835/2020-01-26/genentech-submits-supplemental-biologics 


 https://seekingalpha.com/pr/17759267-genentech-submits-supplemental-biologics-license-application-to-fda-for-tecentriq-in 

 

Genentech Announces Phase III Study Results for Tecentriq Plus Cotellic and Zelboraf in People With Previously Untreated BRAF V600 Mutation-positive Advanced Melanoma

Fri December 13, 2019 1:00 AM|Business Wire|About: RHHBY

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)

 https://seekingalpha.com/pr/17727566-genentech-announces-phase-iii-study-results-for-tecentriq-plus-cotellic-and-zelboraf-in 


 

COTELLIC is a prescription medicine that is used with the medicine ZELBORAF, to treat a type of skin cancer called melanoma:

  • that has spread to other parts of the body or cannot be removed by surgery, and
  • that has a certain type of abnormal “BRAF” gene

 https://www.cotellic.com/ 


 

ZELBORAF® (VEMURAFENIB)

 https://www.gene.com/patients/medicines/zelboraf 

FDA granted accelerated approval to Tecentriq® (atezolizumab) plus chemotherapy (Abraxane®

 

GENENTECH MEDICINE FDA APPROVED AS FIRST CANCER IMMUNOTHERAPY FOR A TYPE OF BREAST CANCER

March 8th, 2019

On March 8, 2019, the FDA granted accelerated approval to Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose tumors express PD-L1, 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 a confirmatory trial(s).


 https://www.tecentriq-hcp.com/ 


 https://www.abraxane.com/ 


 https://media.celgene.com/content/uploads/abraxane-pi.pdf 

 ABRAXANE is a prescription medicine used to treat:  advanced breast cancer in people who have already received certain other medicines for their cancer.  advanced non-small cell lung cancer, in combination with carboplatin in people who cannot be treated with surgery or radiation.  advanced pancreatic cancer, when used in combination with gemcitabine as the first medicine for advanced pancreatic cancer.  

LYNPARZA® (olaparib)

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LYNPARZA® (olaparib)

 

LYNPARZA (olaparib) more than doubled the time without radiographic disease progression in patients with BRCA1/2- or ATM-mutated metastatic castration-resistant prostate cancer


PUBLISHED30 September 2019

AstraZeneca and Merck’s LYNPARZA reduced the risk of disease progression or death by 51% in men with homologous recombination repair (HRR) gene mutations

First positive Phase III trial testing a targeted treatment in biomarker-selected prostate cancer patients

AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada)


 

LYNPARZA (olaparib) More Than Doubled the Time Without Radiographic Disease Progression in Patients With BRCA1/2- or ATM-Mutated Metastatic Castration-Resistant Prostate Cancer

Mon September 30, 2019 10:59 AM|Business Wire|About: AZN 

 https://seekingalpha.com/pr/17647768-lynparza-olaparib-doubled-time-without-radiographic-disease-progression-patients-brca1-2-atm 


 https://www.businesswire.com/news/home/20190930005570/en/ 


 https://www.azpicentral.com/lynparza_tb/lynparza_tb.pdf#page=1 


 https://www.astrazeneca-us.com/content/az-us/media/press-releases/2019/lynparza-olaparib-more-than-doubled-the-time-without-radiographic-disease-progression-in-patients-with-brca12-or-atm-mutated-metastatic-castration-resistant-prostate-cancer-09302019.html 


 https://www.lynparza.com/ 

LYNPARZA (olaparib)

 

LYNPARZA (olaparib) improved the time women lived without disease progression to 22 months in the broad population and to 37 months in hrd-positive patients as 1st-line maintenance treatment with bevacizumab for newly diagnosed advanced ovarian cancer

PUBLISHED28 September 2019

AstraZeneca and Merck’s LYNPARZA added to bevacizumab reduced the risk of disease progression or death by 41% in the overall trial population

AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada


 https://www.astrazeneca-us.com/ 


 https://www.astrazeneca.com/search-results.s.html?q=LYNPARZA+ 


 https://www.astrazeneca.com/our-therapy-areas/oncology.html 


 https://www.lynparza.com/ovarian-cancer/ovarian-cancer-treatment.html 

LYNPARZA® (olaparib)

 https://www.businesswire.com/news/home/20191205005115/en/ 


 

LYNPARZA® (olaparib) Approved in China as a First-Line Maintenance Therapy in BRCA-Mutated (BRCAm) Advanced Ovarian Cancer

AstraZeneca and Merck’s LYNPARZA Reduced the Risk of Disease Progression or Death by 70% Versus Placebo in BRCAm Advanced Ovarian Cancer Following Response to Platinum-Based Chemotherapy

Only PARP Inhibitor Approved in This Setting in China

Thursday, December 5, 2019 6:45 am EST 

 https://www.mrknewsroom.com/news-release/oncology/lynparza-olaparib-approved-china-first-line-maintenance-therapy-brca-mutated-b 


 https://www.azpicentral.com/lynparza_tb/lynparza_tb.pdf#page=1 


 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 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

 https://www.lynparza.com/ovarian-cancer/recurrent-ovarian-cancer.html#isi 


 

LYNPARZA® (olaparib) Recommended by FDA Advisory Committee for First-Line Maintenance Therapy in Germline BRCA-Mutated Metastatic Pancreatic Cancer That Has Not Progressed on Platinum-Based Chemotherapy

Oncologic Drugs Advisory Committee Voted That LYNPARZA Demonstrated a Favorable Benefit-Risk Profile for Patients Based on Phase 3 POLO Trial Results

December 17, 2019 02:09 PM Eastern Standard Time

KENILWORTH, N.J.--(BUSINESS WIRE)--AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada,

 https://www.businesswire.com/news/home/20191217005774/en/ 


 

LYNPARZA® (olaparib) Recommended by FDA Advisory Committee for First-Line Maintenance Therapy in Germline BRCA-Mutated Metastatic Pancreatic Cancer That Has Not Progressed on Platinum-Based Chemotherapy

Oncologic Drugs Advisory Committee Voted That LYNPARZA Demonstrated a Favorable Benefit-Risk Profile for Patients Based on Phase 3 POLO Trial Results

Tuesday, December 17, 2019 2:09 pm EST 

 https://www.mrknewsroom.com/news-release/oncology/lynparza-olaparib-recommended-fda-advisory-committee-first-line-maintenance-th 


 https://www.lynparza.com/#isi 


 

Lynparza recommended by FDA advisory committee for 1st-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer

PUBLISHED17 December 2019

17 December 2019 18:00 GMT
 

ODAC voted that Lynparza demonstrated a clinically meaningful and favourable
risk-benefit profile for patients based on Phase III POLO trial results


AstraZeneca and MSD Inc., Kenilworth, NJ, US (MSD: known as Merck & Co., Inc. inside the US and Canada)

 https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2019/lynparza-recommended-by-fda-advisory-committee-for-1st-line-maintenance-treatment-of-germline-brca-mutated-metastatic-pancreatic-cancer.html 

Lynparza approved in the US 1st-line treatment of germline BRCA-mutated metastatic pancreatic cancer

 

Lynparza approved in the US as a 1st-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer

PUBLISHED30 December 2019

30 December 2019 07:00 GMT
 

Lynparza reduced the risk of disease progression or death by 47% in patients
whose disease had not progressed on at least 16 weeks of a 1st-line platinum-based chemotherapy regimen

Only PARP inhibitor approved in germline BRCA-mutated
metastatic pancreatic cancer
 

AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada

 https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2019/lynparza-approved-in-the-us-as-a-1st-line-maintenance-treatment-of-germline-brca-mutated-metastatic-pancreatic-cancer-30122019.html 

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IMFINZI® (durvalumab) & IMFINZI plus chemotherapy

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IMFINZI plus chemotherapy

 

IMFINZI Is First Immunotherapy to Show Both Significant Survival Benefit and Improved, Durable Responses in Extensive-Stage Small Cell Lung Cancer

Mon September 9, 2019 7:00 AM|Business Wire|About: AZN 


 https://www.businesswire.com/news/home/20190909005297/en/ 


 https://www.azpicentral.com/imfinzi/imfinzi.pdf#page=1 


 

IMFINZI® (durvalumab) and IMFINZI Plus Tremelimumab Delayed Disease Progression in Phase III POSEIDON Trial for 1st-Line Treatment of Stage IV Non-Small Cell Lung Cancer

Mon October 28, 2019 3:14 PM|Business Wire|About: AZN 

 https://seekingalpha.com/pr/17677111-imfinzi-durvalumab-imfinzi-plus-tremelimumab-delayed-disease-progression-phase-iii-poseidon 


 https://www.astrazeneca.com/ 

Imfinzi and tremelimumab granted Orphan Drug Designation in the US for liver cancer

 

AstraZeneca Treatments Win Orphan FDA Status in Liver Cancer

By January 20, 2020, 2:22 AM EST Updated on January 20, 2020, 3:09 AM EST 

 https://www.bloomberg.com/news/articles/2020-01-20/astrazeneca-treatments-gets-orphan-fda-status-in-liver-cancer?srnd=markets-vp 

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ADCETRIS® (brentuximab vedotin)

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FDA Approval of ADCETRIS® (Brentuximab Vedotin) in Combination with Chemotherapy

 

Seattle Genetics Announces FDA Approval of ADCETRIS® (Brentuximab Vedotin) in Combination with Chemotherapy for Adults with Previously Untreated Systemic Anaplastic Large Cell Lymphoma or Other CD30-Expressing Peripheral T-Cell Lymphomas

-First FDA-Approved Regimen in Frontline Peripheral T-Cell Lymphoma-

-FDA Approval Based on Results from the Phase 3 ECHELON-2 Clinical Trial; Data to be Presented at the 2018 ASH Annual Meeting-

-Application Approved Less Than Two Weeks After Submission Under FDA Real-Time Oncology Review Pilot Program-

November 16, 2018 10:52 AM Eastern Standard Time

BOTHELL, Wash.--(BUSINESS WIRE)--Seattle Genetics, Inc. (Nasdaq:SGEN


 https://www.businesswire.com/news/home/20181116005332/en/ 


 https://seagendocs.com/adcetris/pi/734371533_80542-10_Adcetris_Full_Ltr_Master.pdf 


 https://www.cancer.org/cancer/non-hodgkin-lymphoma.html 


 https://www.seattlegenetics.com/ 


 https://www.seattlegenetics.com/products/adcetris-us 


 

Seattle Genetics Announces Health Canada Approval of ADCETRIS® (Brentuximab Vedotin) in Combination with Chemotherapy in Frontline CD30-Expressing Peripheral T-Cell Lymphoma

Mon November 25, 2019 8:00 AM|Business Wire|About: SGEN 

 https://seekingalpha.com/pr/17709695-seattle-genetics-announces-health-canada-approval-adcetris-brentuximab-vedotin-combination 


 https://investor.seattlegenetics.com/press-releases/news-details/2019/Seattle-Genetics-Announces-Progress-in-Expanding-ADCETRIS-Brentuximab-Vedotin-Indications-in-Canada/default.aspx 


 https://www.adcetris.com/#page-isi 

ADCETRIS® (Brentuximab Vedotin)

 

Seattle Genetics Announces Multiple ADCETRIS® (Brentuximab Vedotin) Presentations at the ASH Annual Meeting

-Four-Year Update of the ECHELON-1 Trial Continues to Support Superior Clinical Activity of ADCETRIS in Combination with Chemotherapy when Compared to ABVD in Frontline Advanced Hodgkin Lymphoma-

-Additional Data Analyses Highlight Activities Across Broad ADCETRIS Development Program-

November 07, 2019 08:00 AM Eastern Standard Time

BOTHELL, Wash.--(BUSINESS WIRE)--Seattle Genetics, Inc. (Nasdaq:SGEN)


 https://www.businesswire.com/news/home/20191107005424/en/ 


 https://www.seattlegenetics.com/products/adcetris-us 

ADCETRIS® (brentuximab vedotin)

 

Seattle Genetics and Takeda Announce Additional Analyses of ADCETRIS® (Brentuximab Vedotin) ECHELON-1 and ECHELON-2 Phase 3 Clinical Trials at the 2019 ASH Annual Meeting

- Four-Year Data Continue to Show Superior Progression-Free Survival of ADCETRIS in Combination with AVD when Compared to ABVD in Frontline Advanced Hodgkin Lymphoma with 31 Percent Reduction in the Risk of Progression or Death -

- Additional Analysis from ECHELON-2 Phase 3 Clinical Trial Evaluating ADCETRIS Plus CHP Chemotherapy Also Featured at ASH Annual Meeting -December 09, 2019 10:00 AM Eastern Standard Time 


 https://www.businesswire.com/news/home/20191209005142/en/ 


 https://www.seattlegenetics.com/ 


 https://www.takeda.com/newsroom/newsreleases/2019/seattle-genetics-and-takeda-announce-additional-analyses-of-adcetris-brentuximab-vedotin-echelon-1-and-echelon-2-phase-3-clinical-trials-at-the-2019-ash-annual-meeting/ 


 https://www.seattlegenetics.com/products/adcetris-us 


 https://www.adcetris.com/ 


Blincyto (blinatumomab)

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BLINCYTO® (blinatumomab) Studies In Pediatric Patients With Relapsed Acute Lymphoblastic Leukemia

 

Amgen Announces Positive Results From Two Phase 3 BLINCYTO® (blinatumomab) Studies In Pediatric Patients With Relapsed Acute Lymphoblastic Leukemia

Phase 3 '215 and Children's Oncology Group (COG) Studies Both Stopped Early Due to Treatment Benefit of BLINCYTO Over Chemotherapy  

THOUSAND OAKS, Calif., Sept. 24, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN


 https://www.amgen.com/products/ 


 https://www.prnewswire.com/news-releases/amgen-announces-positive-results-from-two-phase-3-blincyto-blinatumomab-studies-in-pediatric-patients-with-relapsed-acute-lymphoblastic-leukemia-300924297.html 


 https://www.blincyto.com/ 


 https://www.blincyto.com/patient/mrd/ 

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CALQUENCE® (acalabrutinib)

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CALQUENCE® (acalabrutinib)

 

CALQUENCE® Data To Show Improved Progression-Free Survival In Phase III Front-Line Chronic Lymphocytic Leukemia At ASH 2019 Annual Meeting

Wed November 6, 2019 3:16 PM|Business Wire|About: AZN

Robust early-stage pipeline advancements and presentations across multiple scientific platforms demonstrate potential to improve treatment outcomes in blood cancers with high unmet need

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca will present the first data from the Phase III ELEVATE-TN trial assessing CALQUENCE® (acalabrutinib), a next-generation selective Bruton’s tyrosine kinase (BTK) inhibitor, 


 https://www.azpicentral.com/calquence/calquence.pdf#page=1 


 https://www.businesswire.com/news/home/20191106005922/en/ 


 https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2019/calquence-data-to-show-improved-progression-free-survival-in-phase-iii-front-line-chronic-lymphocytic-leukaemia-trial-at-ash-2019-annual-meeting.html 


 https://www.astrazeneca-us.com/ 


 https://www.calquence.com/ 


 https://www.calquencehcp.com/ 



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Selpercatinib (LOXO-292)

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Selpercatinib (LOXO-292) in Heavily Pretreated RET-Altered Thyroid Cancers

 

Lilly Announces Positive Registrational Data for Selpercatinib (LOXO-292) in Heavily Pretreated RET-Altered Thyroid Cancers

09/29/2019 

 - LIBRETTO-001 is the largest trial ever reported in RET-altered cancer patients
- 56 percent objective response rate (ORR) in the registration dataset (n=55) of RET-mutant medullary thyroid cancer (MTC) patients who had previously received cabozantinib and/or vandetanib
- 59 percent ORR in cabozantinib/vandetanib-naïve RET-mutant MTC patients
- 62 percent ORR in heavily pretreated RET fusion-positive thyroid cancer patients
- Sustained durability, measured by both Duration of Response and Progression-Free Survival
- Well-tolerated safety profile; low rate of discontinuation (1.7%) for treatment-related adverse events
- New Drug Application to be submitted by year-end  

INDIANAPOLIS, Sept. 29, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)


 https://www.prnewswire.com/news-releases/lilly-announces-positive-registrational-data-for-selpercatinib-loxo-292-in-heavily-pretreated-ret-altered-thyroid-cancers-300926842.html 


I https://investor.lilly.com/news-releases/news-release-details/lilly-announces-positive-registrational-data-selpercatinib-loxo 


 https://www.lilly.com/newsroom 

Care Beyond Treatment

 At Lilly Oncology, some of us have been touched by cancer one way or another—either as a patient or as a caregiver, relative, or friend of a patient. Cancer disrupts life and changes its course, and we’re determined to provide support beyond treatment to you and your loved ones to help ease the difficult times and celebrate the good ones. Above all, we’re dedicated to creating a community where you and other cancer patients have a network of helpful resources. 

sepercatinib (LOXO-292)

  sepercatinib (LOXO-292) for the treatment of patients with advanced RET fusion-positive non-small cell lung cancer (NSCLC), RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer. 


Lilly Receives FDA Priority Review for the Selpercatinib New Drug Application

 https://www.prnewswire.com/news-releases/lilly-receives-fda-priority-review-for-the-selpercatinib-new-drug-application-300995006.html 

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aducanumab, an investigational treatment for early Alzheimer

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aducanumab reduced clinical decline in patients with early Alzheimer’s disease

 

Biogen Plans Regulatory Filing for Aducanumab in Alzheimer’s Disease Based on New Analysis of Larger Dataset from Phase 3 Studies

Tue October 22, 2019 6:30 AM|GlobeNewswire|About: BIIB

New analysis of larger dataset showed that aducanumab reduced clinical decline in patients with early Alzheimer’s disease as measured by the pre-specified primary and secondary endpoints


 https://seekingalpha.com/pr/17669521-biogen-plans-regulatory-filing-aducanumab-alzheimer-s-disease-based-new-analysis-larger 


 https://biogenalzheimers.com/ 


 http://investors.biogen.com/news-releases/news-release-details/biogen-plans-regulatory-filing-aducanumab-alzheimers-disease 


 https://www.eisai.com/news/2019/news201979.html 


 https://www.biogen.com/ 


 https://www.usagainstalzheimers.org/press/usagainstalzheimers-applauds-positive-news-alzheimers-drug-aducanumab 


 https://www.biospace.com/article/a-stunning-surprise-biogen-and-eisai-s-aducanumab-works-in-alzheimer-s/ 

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Biogen Inc. 2019 Q3 - Results - Earnings Call Presentation

Oct. 22, 2019 7:13 AM ET | About: Biogen Inc. (BIIB) 

Rubraca® (rucaparib)

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Rubraca® (rucaparib)

 

  • Rubraca® (rucaparib) offers a new monotherapy maintenance treatment option for eligible women with relapsed, platinum-sensitive ovarian cancer, who harbor either a BRCA1/2 mutation or are BRCA wild-type
  • Rucaparib provided statistically significant improvement in progression-free survival (PFS) versus placebo in all ovarian cancer patients studied1
  • Some patients with residual disease at ARIEL3 study entry who were treated with rucaparib showed further reduction in tumor burden, including complete responses1
  • Most common Grade ≥3 adverse reaction was anemia; the only serious adverse reaction occurring in >2 percent of patients was anemia2
  • Rucaparib now reimbursed in several countries in Europe with additional countries to follow in 2020

BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (CLVS

 https://www.businesswire.com/news/home/20191113005122/en/ 


 https://www.ema.europa.eu/en/documents/product-information/rubraca-epar-product-information_en.pdf 

 

Pipeline Overview

 https://www.clovisoncology.com/pipeline/pipeline-overview/ 


 https://www.clovisoncology.com/ 

CLVS - Clovis Oncology, Inc.

Rubraca® (rucaparib)

 

Advancing the Fight Against Cancer

 https://www.clovisoncology.com/ 


 

  • Rubraca® (rucaparib) offers a new monotherapy maintenance treatment option for eligible women with relapsed, platinum-sensitive ovarian cancer, who harbor either aBRCA1/2mutation or areBRCAwild-type
  • Rucaparib provided statistically significant improvement in progression-free survival (PFS) versus placebo in all ovarian cancer patients studied1
  • Some patients with residual disease at ARIEL3 study entry who were treated with rucaparib showed further reduction in tumor burden, including complete responses1
  • Most common Grade ≥3 adverse reaction was anemia; the only serious adverse reaction occurring in >2 percent of patients was anemia2
  • Rucaparib now available in multiple countries across Europe

BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (NASDAQ: CLVS)

 https://ir.clovisoncology.com/investors-and-news/news-releases/press-release-details/2020/Clovis-Oncology-Announces-Availability-and-Reimbursement-for-Rubraca-rucaparib-Tablets-for-Women-with-Relapsed-Ovarian-Cancer-in-France/default.aspx