FDA Grants Priority Review for Perioperative Bladder Cancer Treatment

The U.S. Food and Drug Administration (FDA) has accepted for Priority Review a supplemental Biologics License Application (sBLA) for PADCEV™ (enfortumab vedotin-ejfv), in combination with Keytruda® (pembrolizumab), as a perioperative treatment for patients with muscle-invasive bladder cancer (MIBC). This submission seeks to expand the existing indication, which was approved in November 2025 for cisplatin-ineligible MIBC patients, to include all MIBC patients regardless of their cisplatin eligibility.

Priority Review designation is granted by the FDA to medicines that have the potential to offer significant improvements in treatment or provide a therapeutic option where existing treatments are limited. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of August 17, 2026, for this application.

The sBLA is supported by data from the Phase 3 EV-304 trial (also known as KEYNOTE-B15). Results showed that perioperative enfortumab vedotin in combination with pembrolizumab led to a 47% reduction in the risk of tumor recurrence, progression, or death compared to standard neoadjuvant chemotherapy (gemcitabine and cisplatin). The combination also demonstrated a 35% reduced risk of death.

If approved, this combination would become the first and only perioperative treatment for MIBC patients regardless of cisplatin eligibility, potentially establishing a new standard of care. The safety profile observed in the EV-304 trial was consistent with prior experience, and no new safety signals were identified. Astellas Pharma and Pfizer plan to discuss these findings with other global health authorities.