The U.S. Food and Drug Administration accepted Bristol-Myers Squibb Co.'s application for priority review of the company's cancer drug combination to treat a type of kidney cancer.
Bristol-Myers had filed the supplemental biologics license application for priority review of Opdivo plus Yervoy to treat intermediate-and poor-risk patients with advanced renal cell carcinoma.
The application is based on data from the phase 3 CheckMate -214 study, which was stopped early based on the recommendation of an independent data monitoring committee after the drug combination showed superior life expectancy.
Bristol-Myers said the application is expected to be approved by April 16, 2018.
The company said the U.S. FDA previously granted a breakthrough therapy designation for the application, which is the second indication for which the drug combination has received the designation.
