Bristol Myers Gets FDA Priority Review of Opdivo in Muscle-Invasive Urothelial Carcinoma

 Bristol Myers Squibb Co. Friday said the U.S. Food and Drug Administration granted priority review to its application for expanded use of its blockbuster cancer drug Opdivo as an adjuvant treatment for patients with surgically resected, high-risk muscle-invasive urothelial carcinoma.

The New York biopharmaceutical company said the FDA set a target action date of Sept. 3 for the application, which is based on a Phase 3 study in which Opdivo nearly doubled disease-free survival compared to placebo.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.

Bristol Myers said that if approved, Opdivo would be the first adjuvant immunotherapy option for patients with muscle-invasive urothelial carcinoma in the U.S.

Opdivo, which harnesses the body's own immune system to fight cancer, is currently approved in more than 65 countries across multiple cancers.

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