KENILWORTH (NJ) (dpa-AFX) - Merck & Co Inc. (MRK) on Thursday said 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, 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) target action date of April 7, 2026.
The sBLAs are based on data from the Phase 3 KEYNOTE-905 trial.
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