Opdivo nivolumab regulatory update

FDA granted accelerated approval to Opdivo nivolumab from Bristol-Myers Squibb to treat classical Hodgkin’s lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation 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 designation. The approval was based on data from the Phase II CheckMate -205 and Phase I CheckMate -039 trials (see BioCentury, Dec. 15, 2014). Opdivo led to an objective response rate (ORR) of 65% from a combined 95 patients in the trials. ...