Merck Receives US FDA's Priority Review For Two Supplemental Biologics License Applications For KEYTRUDA, KEYTRUDA QLEX To Treat Muscle-invasive Bladder Cancer; FDA Sets April 7, 2026 As Prescription Drug User Fee Act Date

Author: Benzinga Newsdesk | October 23, 2025 06:08am

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted priority review for two supplemental Biologics License Applications (sBLA) for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with Padcev® (enfortumab vedotin-ejfv), for the treatment of patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy. The FDA set a Prescription Drug User Fee Act (PDUFA), or target action, date of April 7, 2026, marking the first concurrent review of both KEYTRUDA and KEYTRUDA QLEX for the same novel indication.

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