Merck & Co., Inc. (NYSE: MRK) has received a favorable recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use. The committee supports the use of the Keytruda and Padcev combination to treat adults with resectable muscle-invasive bladder cancer undergoing radical cystectomy.
The recommendation covers the perioperative combination, which includes the subcutaneous version of Keytruda, for both neoadjuvant and adjuvant treatment. The decision is based on data from the Phase 3 KEYNOTE-B15 study, conducted in collaboration with Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (OTC: ALPMF).
The KEYNOTE-B15 trial demonstrated that the combination therapy reduced the risk of event-free survival events, including disease recurrence, progression, or death, by 47% compared to standard chemotherapy. It also reduced the risk of death by 35% in cisplatin-eligible patients. Additionally, the combination achieved a pathologic complete response rate of 55.8% versus 32.5% for standard chemotherapy.
The European Commission plans to evaluate the committee’s recommendation. A final decision for marketing authorization in the European Union, Iceland, Liechtenstein, and Norway is expected by the fourth quarter of 2026.
This regulatory milestone follows previous approvals. In June 2026, the European Commission authorized the regimen for cisplatin-ineligible patients based on the KEYNOTE-905 trial. In July 2026, the U.S. Food and Drug Administration cleared the Keytruda and Padcev combination for adult patients in the United States, making it the first PD-1 inhibitor and antibody-drug conjugate combination approved for muscle-invasive bladder cancer regardless of cisplatin eligibility.
