The U.S. Food and Drug Administration (FDA) on Friday approved injectable and intravenous versions of Merck’s (MRK) blockbuster anti-PD-1 therapy Keytruda for bladder cancer as part of a combination regimen with Pfizer (PFE) and Astellas’ (OTCPK:ALPMF) (OTCPK:ALPMY) Padcev.
Accordingly, intravenous Keytruda and subcutaneously delivered Keytruda Qlex will be available in the U.S. for use in combination with Padcev, an antibody-drug conjugate, for adults with muscle-invasive bladder cancer.
The treatments are indicated for neoadjuvant treatment (before surgery) followed by adjuvant treatment (after surgery) for those who are ineligible for cisplatin-based chemotherapy, according to the FDA.
The approvals were based on the companies’ KEYNOTE-905 trial, in which Keytruda plus Padcev as perioperative treatment led to statistically significant improvements in event-free survival and overall survival compared to surgery in MIBC patients for whom cisplatin is not indicated.
In October, the agency had accepted the company’s supplemental Biologics License Applications ((sBLA)) for Keytruda and Keytruda Qlex for priority review, granting April 7, 2026, as the target action date.