ARTICLE | Clinical News

Opdivo nivolumab regulatory update

September 29, 2014 7:00 AM UTC

Bristol-Myers said FDA accepted and granted Priority Review to a BLA for Opdivo nivolumab to treat previously treated advanced melanoma. The PDUFA date is March 30, 2015. The pharma said EMA also accepted for accelerated assessment an MAA for the human IgG4 mAb against programmed cell death 1 ( PDCD1; PD-1; CD279) for advanced melanoma. An accelerated assessment shortens the review period to 150 days from 210.

Additionally, BMS said FDA granted Opdivo breakthrough therapy designation for advanced melanoma. The product already has breakthrough therapy designation 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). ...