FDA Grants Priority Review for Keytruda and Padcev Combination for Bladder Cancer Treatment
The U.S. Food and Drug Administration (FDA) has granted priority review to 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). These applications are for the treatment of patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy. The applications are supported by the Phase 3 KEYNOTE-B15 trial results, which demonstrated significant improvements in event-free survival and overall survival. If approved, these regimens would be the first perioperative treatments for MIBC patients regardless of cisplatin eligibility, potentially setting new standards of care. The FDA has set a target action date of August 17, 2026. 
