23 March 2026 - Astellas today announced that the European Medicines Agency (EMA) has validated for review a Type II Variation Application for PADCEVTM (enfortumab vedotin), a Nectin-4 directed antibody-drug conjugate, in combination with Keytruda® (pembrolizumab), a PD-1 inhibitor, as neoadjuvant treatment (before surgery), and then continued after radical cystectomy (surgery) as adjuvant treatment (after surgery), for adults with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-containing chemotherapy.

The application is supported by results from the Phase 3 EV-304 clinical trial (also known as KEYNOTE-B15), which demonstrated that neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab reduced the risk of tumor recurrence, progression, or death by 47% and risk of death by 35% compared with standard of care neoadjuvant gemcitabine and cisplatin chemotherapy.

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