U.S. FDA Approves PADCEV® plus Keytruda® for Certain Patients with Bladder Cancer
PfizerPfizer(US:PFE) Businesswire·2025-11-21 18:24

Core Insights - The U.S. FDA has approved PADCEV® (enfortumab vedotin-ejfv) in combination with Keytruda® (pembrolizumab) or Keytruda QLEX™ for neoadjuvant treatment followed by continued use after cystectomy [1] Company Developments - Pfizer Inc. and Astellas Pharma Inc. jointly announced the FDA approval of PADCEV® [1] - The approval marks a significant advancement in treatment options for patients undergoing cystectomy [1] Industry Impact - The combination therapy of PADCEV® and Keytruda® represents a new approach in the oncology sector, particularly for bladder cancer treatment [1] - This approval may enhance competitive positioning for both Pfizer and Astellas in the immuno-oncology market [1]