U.S. FDA approves PADCEV plus Keytruda for certain patients with bladder cancer

CAR-T Digest - August 2020

25 November 2025: U.S. FDA approves PADCEV plus Keytruda for certain patients with bladder cancer

The FDA has approved PADCEV (enfortumab vedotin-ejfv) plus Keytruda as the first perioperative regimen to significantly improve survival over surgery alone for cisplatin-ineligible patients with muscle-invasive bladder cancer
Approval is based on Phase 3 EV-303 trial results showing a 60% reduction in the risk of recurrence, progression, or death, and a 50% reduction in the risk of death compared with surgery alone
The combination represents the first and only ADC + PD-1 inhibitor regimen for this patient group, setting a potential new standard of care
Event-free survival and overall survival benefits have not yet reached median values in the combination arm, highlighting a strong survival advantage over the surgery-only arm
Safety was consistent with prior data, with no new safety signals, and the regimen is also being evaluated in cisplatin-eligible patients in the EV-304 Phase 3 trial