FDA Approves Merck’s KEYTRUDA + Padcev Regimens For Muscle-Invasive Bladder Cancer
(RTTNews) – 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 and Astellas, which enrolled 808 patients.
In addition, the approvals expand the previously authorized indication based on the Phase 3 KEYNOTE-905 trial (EV-303). That earlier approval covered KEYTRUDA and KEYTRUDA QLEX, each in combination with Padcev, as treatment before and after surgery for adult patients with MIBC who are ineligible for cisplatin-based chemotherapy.
MRK closed Friday’s regular trading at $123.54 down $1.53 or 1.22%.
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