21 October 2025 - Results from the pivotal EV-303 trial demonstrated that, when used before and after surgery, the combination reduced the risk of recurrence, progression or death by 60% and the risk of death by 50% in cisplatin-ineligible patients with muscle-invasive bladder cancer.

Astellas Pharma today announced that the US FDA accepted for priority review a supplemental biologics license application for Padcev (enfortumab vedotin-ejfv) in combination with Keytruda (pembrolizumab) as a neo-adjuvant treatment (before surgery) and then continued after radical cystectomy as adjuvant treatment (after surgery) for patients with muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy.

Read Astellas press release