FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each with Padcev® (enfortumab vedotin-ejfv), as Perioperative Treatment for Adults with Cisplatin-Ineligible Muscle-Invasive Bladder Cancer
MerckMerck(US:MRK) Businesswire·2025-11-21 21:12

Core Viewpoint - Merck has received FDA approval for KEYTRUDA and KEYTRUDA QLEX in combination with Padcev for the treatment of muscle-invasive bladder cancer in adult patients [1] Group 1 - The FDA approved KEYTRUDA (pembrolizumab) as a neoadjuvant treatment and continued as adjuvant treatment after cystectomy for muscle-invasive bladder cancer [1] - KEYTRUDA QLEX, a combination of pembrolizumab and berahyaluronidase alfa-pmph, has also been approved for the same indication [1] - The treatment is specifically for adult patients diagnosed with muscle-invasive bladder cancer (MIBC) [1]