24 November 2015 - The approval is based on data from the Phase 3 trial, CheckMate 066, which evaluated overall survival as the primary endpoint in treatment-naïve patients with BRAF WT unresectable or metastatic melanoma compared to chemotherapy (dacarbazine).
For more details, go to: http://news.bms.com/press-release/bristol-myers-squibb-announces-us-food-and-drug-administration-approval-opdivo-nivolum