Posted by Michael Wonder on 21 Nov 2025
FDA approves pembrolizumab with enfortumab vedotin-ejfv for muscle invasive bladder cancer
21 November 2025 - Today, the FDA approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neo-adjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer who are ineligible for cisplatin.
Efficacy was evaluated in KEYNOTE-905/EV-303, an open-label, randomized, multicenter, active-controlled trial in 344 patients with previously untreated muscle invasive bladder cancer who were candidates for radical cystectomy with pelvic lymph node dissection but were ineligible for or declined cisplatin-based chemotherapy.
