Posted by Michael Wonder on 26 Jun 2026
European Commission approves Keytruda (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) as first PD-1 inhibitor plus antibody-drug conjugate regimen for adults with cisplatin-ineligible resectable muscle-invasive bladder cancer
24 June 2026 - Approval based on results from the Phase 3 KEYNOTE-905 trial in which perioperative Keytruda plus Padcev reduced the risk of event-free survival events by 60% and risk of death by 50% versus surgery alone in these patients
Merck today announced that Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, is approved in the European Union, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy.
