08:47 AM EDT, 10/23/2025 (MT Newswires) -- Merck ( MRK ) said Thursday the US Food and Drug Administration granted priority review for two supplemental biologics license applications for Keytruda and Keytruda Qlex, each used with Padcev, to treat patients with muscle-invasive bladder cancer who cannot receive cisplatin-based chemotherapy.

The company said the regulator set an action date of April 7, 2026.

Merck ( MRK ) said the applications are supported by results from the phase 3 Keynote-905 trial, which showed that Keytruda plus Padcev improved event-free survival and overall survival compared with surgery alone. The combination also increased the rate of complete tumor response.

The trial, conducted with Pfizer ( PFE ) and Astellas Pharma, found the regimen reduced the risk of an event-free survival event by 60% and the risk of death by 50% compared with surgery alone, according to the company.