Merck: FDA grants priority review for two sBLAs for Keytruda, Keytruda Qlex

Merck (MRK) announced that the U.S. FDA has granted priority review for two supplemental Biologics License Applications for Keytruda and Keytruda Qlex, each in combination with Padcev, for the treatment of patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy. The FDA set a Prescription Drug User Fee Act, or target action, date of April 7, 2026, marking the first concurrent review of both Keytruda and Keytruda Qlex for the same novel indication.