FDA to review Opdivo for Hodgkin's lymphoma

FDA accepted and granted Priority Review to an sBLA from Bristol-Myers Squibb Co. (NYSE:BMY) that would expand the label of Opdivo nivolumab to include treatment of classical Hodgkin's lymphoma (cHL) after prior therapies. The PDUFA date is Sept. 1.

Opdivo would be the first FDA-approved PD-1 inhibitor for a hematological malignancy, according to BMS. The pharma said cHL affects about 190,000 patients in the U.S. ...