Padcev With Keytruda Approved for Locally Advanced or Metastatic Urothelial Carcinoma

The FDA gave accelerated approval to enfortumab vedotin-ejfv (Padcev, Astellas Pharma) with pembrolizumab (Keytruda, Merck) to treat patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.

Efficacy was evaluated in EV-103/KEYNOTE-869 (ClinicalTrials.gov Identifier: NCT03288545), a multi-cohort study. The dose-escalation cohort and cohort A were single-arm groups treating patients with enfortumab vedotin-ejfv plus pembrolizumab,