A press release by Bristol-Myers Squibb announced their filing of a supplemental Biologics License Application for Opdivo (nivolumab) in the treatment of previously untreated individuals with advanced melanoma.
Bristol-Myers Squibb Company today announced that the FDA has accepted for filing and review the supplemental Biologics License Application for Opdivo (nivolumab) for the treatment of previously untreated patients with unresectable or metastatic melanoma. The FDA also granted Priority Review for this application. The projected FDA action date is August 27, 2015.
Opdivo was first approved by the FDA in December 2014 for patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor.
Read the complete press release by BMS: http://on.mktw.net/1AkL8w8