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

Approved Approved Nov 21, 2025. Indication: Perioperative treatment of cisplatin ineligible muscle invasive bladder cancer. Company: Merck / Astellas.

Regulatory history

• Nov 21, 2025: Approved. FDA approved Keytruda and Keytruda Qlex each with Padcev as perioperative treatment for cisplatin ineligible MIBC, first PD1 plus ADC regimen for this population merck.com

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