FDA Approves Padcev with Keytruda for Locally Advanced or Metastatic Urothelial Cancer

The FDA approved enfortumab vedotin-ejfv (Padcev, Astellas Pharma) in combination with pembrolizumab (Keytruda, Merck) for patients with locally advanced or metastatic urothelial cancer (la/mUC). FDA previously granted accelerated approval to this combination for patients with la/mUC who are ineligible for cisplatin-containing chemotherapy.

Efficacy was evaluated in EV-302/KN-A39 (ClinicalTrials.gov Identifier: NCT04223856), an open-label, randomized trial of 886 patients with la/mUC and no