Merck received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for perioperative KEYTRUDA plus Padcev in adults with resectable muscle-invasive bladder cancer. The recommendation covers neoadjuvant and adjuvant treatment, including the subcutaneous version KEYTRUDA SC, for patients undergoing radical cystectomy. In the Phase 3 KEYNOTE-B15 trial, conducted alongside Pfizer and Astellas, the combination reduced the risk of event-free survival events by 47% and the risk of death by 35% versus gemcitabine and cisplatin chemotherapy plus surgery in cisplatin-eligible patients. The pathologic complete response rate was 55.8%, compared with 32.5% for standard chemotherapy. The European Commission is expected to decide on marketing authorization in the European Union, Iceland, Liechtenstein and Norway by the fourth quarter of 2026.