FDA grants accelerated approval to enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial carcinoma

On April 3, 2023, the Food and Drug Administration granted accelerated approval to enfortumab vedotin-ejfv (Padcev, Astellas Pharma) with pembrolizumab (Keytruda, Merck) for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.

Source: FDA Center for Drug Evaluation and Research - What's New - April 3, 2023 Category: Drugs & Pharmacology Authors: FDA Source Type: news