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APRIL 5, 2023

Padcev With Keytruda Approved for Locally Advanced or Metastatic Urothelial Carcinoma


Originally published by our sister publication Clinical Oncology News

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