Oncology Drug Advisory Committee

Health Canada Accepts New Drug Submission for Lecanemab as Treatment for Early Alzheimer's Disease

Retrieved on: 
Tuesday, May 16, 2023
Priority review, The New England Journal of Medicine, Plaque, NDS, Alzheimer's disease, MHLW, Marketing, Neurotoxicity, Food, Advisory Committee, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, Lecanemab, Ministry of Health, Labour and Welfare, Brain, Medication, Pharmaceuticals and Medical Devices Agency, Oncology Drug Advisory Committee, EMA, Clarity, Ministry, Eisai, The Different Forms of Flowers on Plants of the Same Species, Prescription Drug User Fee Act, PMDA, National Medical Products Administration, Co-promotion, PDUFA, Ministry of Health (Kuwait), MAA, AD, FDA, Phase, Health Canada, BLA, NMPA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Disease, Medical imaging, Pharmaceutical industry, Biogen, Health

Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.

Key Points: 
  • Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease.
  • The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.
  • Lecanemab was approved under the accelerated approval pathway in the U.S. and was launched in the U.S. on January 18, 2023.

Health Canada Accepts New Drug Submission for Lecanemab as Treatment for Early Alzheimer’s Disease

Retrieved on: 
Tuesday, May 16, 2023
Priority review, The New England Journal of Medicine, Plaque, NDS, MHLW, Marketing, Neurotoxicity, Food, Advisory Committee, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, Lecanemab, BIIB, Ministry of Health, Labour and Welfare, Brain, Pharmaceuticals and Medical Devices Agency, Medication, Oncology Drug Advisory Committee, EMA, Clarity, Ministry, The Different Forms of Flowers on Plants of the Same Species, Eisai, Prescription Drug User Fee Act, Headquarters, PMDA, National Medical Products Administration, Corporation, Co-promotion, PDUFA, Ministry of Health (Kuwait), MAA, AD, FDA, Phase, Health Canada, BLA, NMPA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Disease, Pharmaceutical industry, Biogen, Health

Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.

Key Points: 
  • Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease.
  • The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.
  • Lecanemab was approved under the accelerated approval pathway in the U.S. and was launched in the U.S. on January 18, 2023.

Update on FDA Advisory Committee Vote on LYNPARZA® (olaparib) Plus Abiraterone and Prednisone or Prednisolone in First-Line Metastatic Castration-Resistant Prostate Cancer

Retrieved on: 
Friday, April 28, 2023
Biotechnology, General Health, Health, Pharmaceutical, Oncology, MSD, Prednisolone, Oncology Drug Advisory Committee, The New England Journal of Medicine, New Drug Application, Cancer, MRK, ODAC, AstraZeneca, NEJM, Merck & Co., Prednisone, Incidence, Surgical oncology, Urology, HIV disease progression rates, Patient, Physician, Risk, GenesisCare, Propel, Mortality, BRCA, FDA, Death, News, NYSE, Food, Caregiver, Prostate cancer, Pharmaceutical industry, Medical imaging, Merck

The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients, recommending against approval beyond this patient population.

Key Points: 
  • The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients, recommending against approval beyond this patient population.
  • The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer.
  • The FDA is not bound by the committee’s guidance but takes its advice into consideration.
  • AstraZeneca and Merck will continue to work with the FDA as the agency completes its review of the application.

FDA Accepts Eisai's Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBITM (lecanemab-irmb) for the Treatment of Alzheimer's Disease

Retrieved on: 
Monday, March 6, 2023
The New England Journal of Medicine, Brain, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Co-promotion, Pathology, Priority review, BIIB, Lecanemab, Patient, Clarity, FDA, Clinical trial, Oncology Drug Advisory Committee, PDUFA, Prescription Drug User Fee Act, Food, Advisory Committee, AD, Plaque, Immunoglobulin G, Pharmaceutical industry, Medical imaging, Alzheimer's disease, Biogen, Eisai

The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023.

Key Points: 
  • The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023.
  • The FDA is currently planning to hold an Advisory Committee to discuss this application but has not yet publicly announced the date of the meeting.
  • On the same day that LEQEMBI received its accelerated approval, Eisai submitted the sBLA to the FDA for approval under the traditional pathway.
  • The sBLA is based on the findings from Eisai's recently published large, global confirmatory Phase 3 clinical trial, Clarity AD.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Y-mAbs Therapeutics, Inc. - YMAB

Retrieved on: 
Friday, March 10, 2023
Bias, Survival, Therapy, News, Biologics license application, Patient, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Oncology Drug Advisory Committee, House (season 5), CNS, Cryptocurrency, Pharmaceutical industry

NEW YORK, March 10, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Y-mAbs Therapeutics, Inc. (“Y-mAbs” or the “Company”) (NASDAQ: YMAB).

Key Points: 
  • NEW YORK, March 10, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Y-mAbs Therapeutics, Inc. (“Y-mAbs” or the “Company”) (NASDAQ: YMAB).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether Y-mAbs and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions.

Intercept Announces FDA Advisory Committee Meeting Date for Obeticholic Acid as a Treatment for Pre-Cirrhotic Liver Fibrosis due to NASH

Retrieved on: 
Friday, March 10, 2023
Clinical trial, OCA, Intercept, Prescription Drug User Fee Act, Committee, Liver transplantation, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Intercept Pharmaceuticals, Fatty liver disease, NDA, PDUFA, Advisory Committee, NASH, Therapy, Oncology Drug Advisory Committee, Pharmaceutical industry

MORRISTOWN, N.J., March 10, 2023 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that the Gastrointestinal Drugs Advisory Committee (GIDAC) of the U.S. Food and Drug Administration (FDA) will discuss Intercept’s new drug application (NDA) for obeticholic acid (OCA) as a treatment for pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH) on May 19, 2023. The Advisory Committee Meeting will be hosted as a virtual meeting.

Key Points: 
  • The Advisory Committee Meeting will be hosted as a virtual meeting.
  • “There are currently no approved treatment options for people living with NASH, a devastating disease and the most rapidly growing cause of liver transplantation in the U.S.,” said Jerry Durso, President and Chief Executive Officer of Intercept.
  • “We look forward to the opportunity to discuss with the Advisory Committee our clinical trial data demonstrating the strong and confirmed antifibrotic effect of OCA, as well as its manageable safety profile in NASH.”
    As previously reported, the Prescription Drug User Fee Act (PDUFA) target action date is June 22, 2023.
  • The timeline for review of the NDA by FDA remains subject to change.

FDA Advisory Committee Votes in Favor of the Clinical Benefit of Genentech's Polivy Combination for People With Previously Untreated Diffuse Large B-Cell Lymphoma

Retrieved on: 
Thursday, March 9, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Oncology Drug Advisory Committee, Doxorubicin, Rituximab, ODAC, Vincristine, DLBCL, Death, Journal of the National Comprehensive Cancer Network, RO, Regulation of tobacco by the U.S. Food and Drug Administration, ROG, Patient, Risk, Phase, Food, Progression-free survival, Prednisone, HIV disease progression rates, B-cell lymphoma, Roche, PFS, NCCN, Cyclophosphamide, Pharmaceutical industry, Polatuzumab vedotin, Genentech

The ODAC provides the FDA with independent opinions and recommendations from outside medical experts though the recommendations are not binding.

Key Points: 
  • The ODAC provides the FDA with independent opinions and recommendations from outside medical experts though the recommendations are not binding.
  • The FDA is expected to make a final decision on its review of the supplemental Biologics License Application (sBLA) for Polivy in this indication by April 2, 2023.
  • DLBCL is an aggressive, hard-to-treat disease and is the most common form of non-Hodgkin’s lymphoma in the United States.
  • Limited progress has been made in improving patient outcomes in previously untreated DLBCL over the last two decades.

Merck and AstraZeneca Provide Update on US Regulatory Review of LYNPARZA® (olaparib) for Use in Combination With Abiraterone and Prednisone or Prednisolone for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Retrieved on: 
Thursday, March 2, 2023
Biotechnology, Pharmaceutical, Men, Oncology, Health, FDA, Consumer, Clinical Trials, MSD, NYSE, Prednisolone, Propel, American Society of Clinical Oncology, Oncology Drug Advisory Committee, RPF, Society, Cancer, Patient, GU, European, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, The New England Journal of Medicine, ODAC, MRK, Food, Prednisone, ASCO, Shanda, AstraZeneca, NEJM, Pharmaceutical industry, Merck

The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer.

Key Points: 
  • The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer.
  • The FDA is not bound by the committee’s guidance but takes its advice into consideration.
  • AstraZeneca and Merck are committed to working with the FDA to bring LYNPARZA in combination with abi/pred to patients diagnosed with mCRPC.
  • LYNPARZA in combination with abi/pred is approved in the European Union and several other countries for the treatment of adult patients with mCRPC, based on the PROpel trial.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Y-mAbs Therapeutics, Inc. - YMAB

Retrieved on: 
Wednesday, March 1, 2023
FDA, Patient, House (season 5), Biologics license application, Bias, CNS, Food, Regulation of tobacco by the U.S. Food and Drug Administration, Oncology Drug Advisory Committee, Therapy, News, Survival, Pharmaceutical industry, Cryptocurrency

NEW YORK, March 01, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Y-mAbs Therapeutics, Inc. (“Y-mAbs” or the “Company”) (NASDAQ: YMAB).

Key Points: 
  • NEW YORK, March 01, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Y-mAbs Therapeutics, Inc. (“Y-mAbs” or the “Company”) (NASDAQ: YMAB).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether Y-mAbs and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Y-mAbs Therapeutics, Inc. - YMAB

Retrieved on: 
Monday, February 20, 2023
Bias, Biologics license application, House (season 5), Patient, News, Food, CNS, Therapy, Survival, Oncology Drug Advisory Committee, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Pharmaceutical industry, Cryptocurrency

NEW YORK, Feb. 20, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Y-mAbs Therapeutics, Inc. (“Y-mAbs” or the “Company”) (NASDAQ: YMAB).

Key Points: 
  • NEW YORK, Feb. 20, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Y-mAbs Therapeutics, Inc. (“Y-mAbs” or the “Company”) (NASDAQ: YMAB).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether Y-mAbs and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions.