Merck's Keytruda Wins EU Recommendation for Bladder Cancer Treatment
Merck & Co., Inc.'s (NYSE:MRK) Keytruda has secured a favorable recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use. The committee backed the perioperative combination of Keytruda, including its subcutaneous version KEYTRUDA SC, as a neoadjuvant and adjuvant treatment for patients undergoing radical cystectomy. This decision was based on data from the Phase 3 KEYNOTE-B15 study.
The trial demonstrated that the perioperative Keytruda plus Padcev regimen cut the risk of event-free survival events by 47% compared to traditional chemotherapy plus surgery in cisplatin-eligible patients. Additionally, the combination reduced the risk of death by 35% and achieved a pathologic complete response rate of 55.8% versus 32.5% for standard chemotherapy.
The European Commission plans to evaluate this recommendation and is expected to make a final decision on marketing authorization in the European Union, Iceland, Liechtenstein, and Norway by the fourth quarter of 2026.