Astellas Pharma and Pfizer have announced that the US Food and Drug Administration (FDA) has accepted for Priority Review a supplemental Biologics License Application (sBLA) for the perioperative use of Padcev (enfortumab vedotin-ejfv) in combination with Keytruda (pembrolizumab) for patients with muscle-invasive bladder cancer (MIBC).

The filing seeks to broaden the current indication of the combination therapy to include all eligible MIBC patients, regardless of their suitability for cisplatin-based chemotherapy. The regimen had previously received FDA approval in November 2025 for use in cisplatin-ineligible patients.

The application is supported by data from the Phase III EV-304 clinical trial, which evaluated the combination therapy in comparison with standard neoadjuvant chemotherapy. Results demonstrated a 47 percent reduction in the risk of disease recurrence, progression or death, along with a 35 percent reduction in the risk of death. The study also reported a higher pathological complete response rate in patients receiving the combination therapy compared to those on chemotherapy.

The safety profile of the combination was consistent with earlier findings, with no new safety concerns identified during the trial.

Muscle-invasive bladder cancer remains a significant clinical challenge, with high recurrence rates even after surgery. The combination therapy is being positioned as a potential option to improve outcomes in both pre and post surgical settings.

Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of August 17, 2026, for its decision on the application.