The U.S. Food and Drug Administration expanded the approval of pembrolizumab (Keytruda) and its subcutaneous formulation (Keytruda Qlex), each in combination with enfortumab vedotin (Padcev), to cover all adults with muscle-invasive bladder cancer who are candidates for surgery to remove their bladder, according to the FDA's official announcement on July 10, 2026.
The expansion removes a significant prior restriction: until this approval, the combination was permitted in this surgical setting only for patients who could not safely receive cisplatin, a standard platinum-based chemotherapy drug. The combination is now approved as neoadjuvant therapy given before surgery, followed by continued adjuvant treatment after the bladder is removed, regardless of cisplatin eligibility.
