India, July 11 -- Merck & Co Inc. (MRK) announced that the U.S. Food and Drug Administration approved KEYTRUDA (pembrolizumab) and KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph), the company's anti-PD-1 therapies, each in combination with Padcev (enfortumab vedotin-ejfv). These regimens are now authorized as neoadjuvant treatment before cystectomy and continued as adjuvant treatment afterward for adult patients with muscle-invasive bladder cancer (MIBC).
The approvals mark the first and only PD-1 inhibitor plus antibody-drug conjugate (ADC) regimens approved for adults with MIBC, regardless of cisplatin eligibility. They are based on results from the Phase 3 KEYNOTE-B15 trial (EV-304), conducted in collaboration with Pfizer ...