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European Commission Approves Merck’s KEYTRUDA® and Padcev® as First-Line Therapy for Unresectable or Metastatic Urothelial Carcinoma in Adults.

NextEdge Admin

04 Sep 2024

2 min 16 sec

Merck , known as MSD outside the U.S. and Canada, has announced that the European Commission (EC) has approved the combination of KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy, with Padcev® (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults. This approval aligns with the recent recommendations from the European Society for Medical Oncology and the European Association of Urology, which endorse this combination as the preferred first-line treatment, regardless of platinum eligibility.

The EC's decision follows a positive recommendation from the Committee for Medicinal Products for Human Use in July 2024. This was based on interim results from the Phase 3 KEYNOTE-A39 (EV-302) trial, a collaborative study with Pfizer and Astellas. The trial demonstrated that KEYTRUDA combined with enfortumab vedotin significantly improved overall survival (OS) and progression-free survival (PFS) compared to platinum-based chemotherapy.

At a median follow-up of 17.3 months, the combination therapy reduced the risk of death by 53% and the risk of disease progression or death by 55% compared to chemotherapy.

Dr. Marjorie Green, Merck's senior vice president and head of oncology, expressed satisfaction with the EC's decision, highlighting the potential of this new treatment option to extend the lives of patients with advanced urothelial carcinoma. The approval applies across all 27 EU member states and additional regions, marking a significant expansion of KEYTRUDA's approved indications in bladder cancer.