FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) for the Treatment of Patients with Advanced Hepatocellular Carcinoma
Merck & Company, Inc. (new) (MRK)
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Source: Business Wire
Application Based on Monotherapy Data from Phase 2 KEYNOTE-224 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) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, as a treatment for previously treated patients with advanced hepatocellular carcinoma (HCC). 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 n
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