Merck (NYSE:MRK), known as MSD outside the U.S. and Canada, announced today that the U.S. Food and Drug Administration (FDA) has granted priority review for two supplemental Biologics License Applications (sBLA) involving its anti-PD-1 therapy, Keytruda.
The applications cover both the standard intravenous formulation and the subcutaneous version, Keytruda Qlex, each in combination with Padcev (enfortumab vedotin-ejfv), for the treatment of patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy.
The FDA has established a Prescription Drug User Fee Act (PDUFA) target action date of August 17, 2026.
If approved, the regimen would become the first perioperative treatment for MIBC patients regardless of their eligibility for cisplatin-based chemotherapy, significantly expanding the therapeutic window for the Keytruda-Padcev combination.
The filings are supported by results from the Phase 3 KEYNOTE-B15 trial (also known as EV-304), conducted in collaboration with Pfizer and Astellas.
Data from the study, recently presented at the ASCO Genitourinary Cancers Symposium, indicated that the combination therapy could challenge the current standard of care.
Despite curative-intent surgery and chemotherapy, many MIBC patients historically face disease progression or limited survival rates.