enfortumab vedotin (Padcev) plus pembrolizumab (Keytruda) (Padcev/Keytruda): FDA status

Approved Approved Aug 14, 2026. Indication: Cisplatin ineligible muscle invasive bladder cancer. Company: Merck.

Regulatory history

• Aug 14, 2026: Label expanded. FDA broadened use of pembrolizumab plus enfortumab vedotin in muscle invasive bladder cancer. Clinical Oncology News
• Oct 22, 2025: Priority review. FDA granted priority review to the sBLA for enfortumab vedotin plus pembrolizumab in cisplatin ineligible MIBC with PDUFA date April 7 2026 urologytimes.com

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