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FDA Grants Priority Review to Keytruda for Patients with High-Risk, Non–Muscle-Invasive Bladder Cancer

Yvette Florio Lane

Bladder Cancer, FDA Approvals, News & Updates, Immunotherapy

On December 2, 2019, Merck announced that the FDA has granted priority review for its supplemental biologics license application for the anti–PD-1 agent pembrolizumab (Keytruda). If approved, the drug would be indicated as monotherapy to treat patients with Bacillus Calmette-Guerin–unresponsive, high-risk, non–muscle-invasive bladder cancer who are ineligible for or have decided not to undergo cystectomy. [ Read More ]