EMA validates Opdivo MAA

Bristol-Myers Squibb Co. (NYSE:BMY) said EMA validated an MAA for Opdivo nivolumab to treat non-small cell lung cancer (NSCLC). The pharma said the application is the "first completed regulatory submission" for a PD-1 inhibitor in that tumor type.

Opdivo, a human IgG4 mAb against programmed cell death 1 ( PDCD1; PD-1; CD279), already is under EMA review to treat advanced melanoma. By year end, BMS intends to complete an ongoing submission of a rolling BLA to FDA for Opdivo as a third-line treatment for squamous cell NSCLC. ...