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.
BMS markets Opdivo to treat metastatic non-small cell lung cancer (NSCLC), advanced renal cell carcinoma (RCC) and melanoma. Seattle Genetics Inc. (NASDAQ:SGEN) and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) market Adcetris, an antibody-drug conjugate (ADC) composed of an anti-CD30 mAb and monomethyl auristatin E (MMAE).
Published on Tuesday, May 17, 2016