FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA (pembrolizumab) for the Treatment of Patients with Advanced Hepatocellular Carcinoma

- July 11th, 2018

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) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, as a treatment for previously treated patients with advanced hepatocellular carcinoma (HCC). As … Continued

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) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, as a treatment for previously treated patients with advanced hepatocellular carcinoma (HCC).

As quoted in the press release:

This sBLA, which is seeking accelerated approval for this new indication, is based on data from the Phase 2 KEYNOTE-224 trial, which were recently presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting and published simultaneously in The Lancet Oncology. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Nov. 9, 2018.

“There continues to be a significant need for new options in the treatment of advanced hepatocellular carcinoma, which is the most common type of liver cancer,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “The data supporting our application provide a clear rationale for the advancement of the KEYTRUDA clinical program for hepatocellular carcinoma, and we are grateful for the opportunity to work with the FDA to potentially bring KEYTRUDA to patients living with this difficult-to-treat cancer.”

Click here to read the full press release.

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