- AustraliaNorth AmericaWorld
Investing News NetworkYour trusted source for investing success
- Lithium Outlook
- Oil and Gas Outlook
- Gold Outlook Report
- Uranium Outlook
- Rare Earths Outlook
- All Outlook Reports
- Top Generative AI Stocks
- Top EV Stocks
- Biggest AI Companies
- Biggest Blockchain Stocks
- Biggest Cryptocurrency-mining Stocks
- Biggest Cybersecurity Companies
- Biggest Robotics Companies
- Biggest Social Media Companies
- Biggest Technology ETFs
- Artificial Intellgience ETFs
- Robotics ETFs
- Canadian Cryptocurrency ETFs
- Artificial Intelligence Outlook
- EV Outlook
- Cleantech Outlook
- Crypto Outlook
- Tech Outlook
- All Market Outlook Reports
- Cannabis Weekly Round-Up
- Top Alzheimer's Treatment Stocks
- Top Biotech Stocks
- Top Plant-based Food Stocks
- Biggest Cannabis Stocks
- Biggest Pharma Stocks
- Longevity Stocks to Watch
- Psychedelics Stocks to Watch
- Top Cobalt Stocks
- Small Biotech ETFs to Watch
- Top Life Science ETFs
- Biggest Pharmaceutical ETFs
- Life Science Outlook
- Biotech Outlook
- Cannabis Outlook
- Pharma Outlook
- Psychedelics Outlook
- All Market Outlook Reports
FDA Accepts Supplemental Biologics License Application for Merck’s KEYTRUDA as Adjuvant Therapy in Advanced Melanoma
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 for standard review a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, as adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma and granted a …
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 for standard review a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, as adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma and granted a Prescription Drug User Fee Act (PDUFA), or target action, date of February 16, 2019.
As quoted in the press release:
“EORTC1325/KEYNOTE-054 was the first trial with KEYTRUDA to demonstrate a recurrence-free survival benefit in the adjuvant setting, and we continue to actively investigate KEYTRUDA in the adjuvant or neoadjuvant setting across our broad clinical development program,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “Earlier intervention with adjuvant therapy has proven to be an important factor in reducing the risk of recurrence following surgery for patients with high-risk stage III melanoma. We look forward to working with the FDA on the review of this application, with the goal of bringing KEYTRUDA to patients with advanced melanoma earlier in their treatment.”
Merck’s long-term commitment to melanoma includes a broad clinical development program studying KEYTRUDA as monotherapy and in combination with other novel mechanisms. The program, which is comprised of more than 4,500 patients across 10 Merck-sponsored clinical studies, is evaluating KEYTRUDA across most settings and stages of the disease.
Latest News
Investing News Network websites or approved third-party tools use cookies. Please refer to the cookie policy for collected data, privacy and GDPR compliance. By continuing to browse the site, you agree to our use of cookies.