Posted by Michael Wonder on 02 Dec 2025
EMA validates type II variation application for Padcev (enfortumab vedotin) with Keytruda (pembrolizumab) for certain patients with muscle-invasive bladder cancer
1 December 2025 - Astellas Pharma today announced that the EMA validated for review a type II variation application for Padcev (enfortumab vedotin), a Nectin-4 directed antibody-drug conjugate, in combination with Keytruda (pembrolizumab), a PD-1 inhibitor, as neo-adjuvant treatment, and then continued after radical cystectomy as adjuvant treatment, for adults with muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy.
The type II variation application is based on results from the Phase 3 EV-303 clinical trial (also known as KEYNOTE-905).
