Merck (MSD) and Astellas Secure Positive EU CHMP Opinion for Keytruda (Pembrolizumab) + Padcev (Enfortumab Vedotin-Ejfv) as Perioperative Treatment in Resectable Muscle-Invasive Bladder Cancer Based on Phase 3 KEYNOTE-B15/EV-304
Merck (NYSE: MRK; MSD outside North America) and Astellas (TSE: 4503) announced Friday September 18, 2026 that the EMA's CHMP issued a positive opinion recommending EU marketing authorization for Keytruda (pembrolizumab, anti-PD-1 monoclonal antibody) in combination with Padcev (enfortumab vedotin-ejfv, Nectin-4-directed antibody-drug conjugate developed with Pfizer) as perioperative treatment — neoadjuvant before radical cystectomy, continued as adjuvant — for adults with resectable muscle-invasive bladder cancer (MIBC). The recommendation is based on Phase 3 KEYNOTE-B15/EV-304 data documenting statistically significant improvements in event-free survival (primary endpoint), overall survival, and pathologic complete response rate versus neoadjuvant cisplatin-based chemotherapy followed by adjuvant standard of care. European Commission decision is expected in Q4 2026. This would be the first perioperative regimen combining a PD-1 inhibitor with an antibody-drug conjugate to reach European regulatory approval in MIBC and follows the September 2026 FDA approval of the same regimen (plus KEYTRUDA QLEX subcutaneous formulation with berahyaluronidase alfa-pmph) for cisplatin-ineligible MIBC patients.