Merck and Astellas Receive Positive CHMP Opinion for Keytruda Plus Padcev Before and After Surgery in Resectable Muscle-Invasive Bladder Cancer
Merck announced on Friday, September 18, 2026 that the CHMP recommended approval of Keytruda (pembrolizumab) with Padcev (enfortumab vedotin) as neoadjuvant treatment, continued after radical cystectomy as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer; the recommendation also covers subcutaneous Keytruda. In the Phase 3 KEYNOTE-B15 (EV-304) trial, the regimen reduced the risk of an event-free survival event by 47% and the risk of death by 35% versus gemcitabine and cisplatin chemotherapy plus surgery, and the pathologic complete response rate was 55.8% versus 32.5%. Merck said it would be the first and only PD-1 inhibitor plus antibody-drug conjugate regimen for muscle-invasive bladder cancer regardless of cisplatin eligibility in the EU. A European Commission decision is expected by the fourth quarter of 2026, and the FDA approved the combination for this use in July 2026. Merck's partners on the regimen are Astellas and Pfizer.