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European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) as First-Line Treatment of Unresectable or Metastatic Urothelial Carcinoma in Adults

Published: 2024-09-03 10:45:00 ET

Approval of KEYTRUDA plus enfortumab vedotin brings a potential new first-line standard of care to these patients in the European Union

RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults. The decision follows the adoption of the European Society for Medical Oncology and European Association of Urology clinical guidelines recommending the combination as the preferred first-line treatment for these patients, regardless of platinum eligibility.

This approval by the EC also follows the positive recommendation from the Committee for Medicinal Products for Human Use received in July 2024, which was based on results from the first interim analysis of the Phase 3 KEYNOTE-A39 trial (also known as EV-302), which was conducted in a research collaboration with Pfizer (previously Seagen) and Astellas. In KEYNOTE-A39, KEYTRUDA plus enfortumab vedotin demonstrated statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS) versus platinum-based chemotherapy (gemcitabine plus cisplatin or carboplatin).

At a median follow-up of 17.3 months (range, 0.3 to 37.2 months), the KEYTRUDA plus enfortumab vedotin combination reduced the risk of death by 53% (HR=0.47 [95% CI, 0.38-0.58]; p

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