FDA Grants Priority Review to PADCEV + Keytruda for Perioperative Muscle-Invasive Bladder Cancer

The US FDA granted Priority Review to Astellas/Pfizer's supplemental Biologics License Application (sBLA) for enfortumab vedotin-ejfv (PADCEV, an ADC targeting Nectin-4) combined with pembrolizumab (Keytruda) as perioperative treatment for muscle-invasive bladder cancer (MIBC) regardless of cisplatin eligibility. If approved, this would mark the first regulatory acceptance of an ADC-based perioperative regimen in bladder cancer — expanding use beyond the current metastatic setting where the combination became standard of care. PADCEV+Keytruda already holds approvals for frontline metastatic urothelial carcinoma based on the EV-302/KEYNOTE-A39 trial, which showed a 53% reduction in the risk of death vs. chemotherapy. The Priority Review designation carries a 6-month review clock, potentially enabling an approval decision later in 2026.