Padcev-Keytruda wins broader FDA approval in bladder cancer

The US Food and Drug Administration (FDA) has approved pharma giant Pfizer (NYSE: PFE) and Japanese drugmaker Astellas Pharma’s (TYO: 4503) Padcev (enfortumab vedotin-ejfv) plus Merck & Co’s (NYSE: MRK) Keytruda (pembrolizumab) as neoadjuvant and adjuvant treatment for adults with muscle-invasive bladder cancer (MIBC), regardless of cisplatin eligibility.

This expanded approval makes the combination the first platinum-free regimen cleared in the USA for this patient group, broadening a November 2025 indication that covered only adults with MIBC who were ineligible for cisplatin-based chemotherapy.