Opdivo nivolumab regulatory update

FDA accepted and granted Priority Review to an sBLA from Bristol-Myers for Opdivo nivolumab plus Yervoy ipilimumab to treat patients with previously untreated advanced melanoma. The PDUFA date is Sept. 30.

Opdivo, a human IgG4 mAb against PD-1, is approved in the U.S. to treat patients with unresectable or metastatic melanoma and disease progression following Yervoy and, if BRAF V600 mutation-positive, a BRAF inhibitor and to treat metastatic squamous non-small cell lung cancer (NSCLC). ...