Opdivo nivolumab regulatory update

EMA’s CHMP recommended approval for Opdivo nivolumab from Bristol-Myers as monotherapy to treat advanced melanoma in adults. The human IgG4 mAb against programmed cell death 1 ( PDCD1; PD-1; CD279) is under accelerated review in the EU for the indication. An MAA is also under review in the EU to treat non-small cell lung cancer (NSCLC). ...