Padcev (Enfortumab vedotin) plus Keytruda (Pembrolizumab) sBLA granted FDA priority review for treatment of certain patients with muscle-invasive bladder cancer

CAR-T Digest - August 2020

Weekly Digest - October 2025

21 October 2025: Padcev (Enfortumab vedotin) plus Keytruda (Pembrolizumab) sBLA granted FDA priority review for treatment of certain patients with muscle-invasive bladder cancer

The FDA has accepted a supplemental Biologics License Application (sBLA) for Padcev plus Keytruda for priority review as neoadjuvant and adjuvant treatment in cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC)
The submission is based on Phase 3 EV-303 (KEYNOTE-905) trial results, comparing the combination therapy to surgery alone
The combination reduced the risk of recurrence, progression, or death by 60% and the risk of death by 50% in the trial
If approved, Padcev plus Keytruda could significantly change the treatment paradigm for MIBC
The FDA’s target action date under the PDUFA is April 7, 2026, and no new safety concerns were observed in the trial