Opdivo nivolumab regulatory update

Bristol-Myers said EMA accepted for review an MAA for Opdivo nivolumab to treat non-small cell lung cancer (NSCLC). An MAA for the human IgG4 mAb against programmed cell death 1 ( PDCD1; PD-1; CD279) is already under accelerated assessment for advanced melanoma (see BioCentury, Sept. 29). Accelerated assessment shortens the review period to 150 days from 210.

Last month, BMS said FDA accepted and granted Priority Review to a BLA for Opdivo to treat previously treated advanced melanoma. The PDUFA date is March 30, 2015. Opdivo has breakthrough therapy designation in the U.S. for advanced melanoma and for Hodgkin's lymphoma after failure of autologous stem cell transplant (ASCT) and Adcetris brentuximab from Seattle Genetics Inc. (NASDAQ:SGEN, Bothell, Wash.) and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502, Osaka, Japan). The product also has Fast Track designation in the U.S. to treat NSCLC, renal cell carcinoma (RCC) and melanoma. ...