Merck (NYSE:MRK) announced on Thursday that the FDA has granted priority review for two of its marketing applications aimed at expanding the U.S. indications of injectable and intravenous versions of its blockbuster anti-PD-1 therapy Keytruda for bladder cancer as part of a combination regimen.
According to MRK, the agency has accepted its supplemental Biologics License Applications (sBLA) that sought approval of Keytruda injection and subcutaneous-delivered Keytruda Qlex when used with Pfizer (PFE) and Astellas’ (OTCPK:ALPMF) (OTCPK:ALPMY), Padcev.
Specifically, the sBLAs backed by data from the company’s Phase 3 KEYNOTE-905 trial seek approval of Keytruda formulations with Padcev for patients with muscle-invasive bladder cancer for whom cisplatin-based chemotherapy is not indicated.
In connection with the review, the FDA has assigned April 7, 2026, as the target action date, Merck (NYSE:MRK) said, adding that its decision marked the beginning of the first concurrent review of Keytruda and Keytruda Qlex for a new indication.