Opdivo approved quickly for first hematological cancer

FDA granted accelerated approval to Opdivo nivolumab from Bristol-Myers Squibb Co. (NYSE:BMY) to treat classical Hodgkin's lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and treatment with Adcetris brentuximab vedotin. BMS said Opdivo is the first FDA-approved PD-1 inhibitor for a hematological malignancy.

The approval came well ahead of Opdivo's Sept. 1 PDUFA date in the indication, for which it has breakthrough therapy and Orphan Drug designations. ...