Posted by Michael Wonder on 08 Jun 2017
Bristol-Myers Squibb announces US FDA approval for Opdivo (nivolumab) as a single agent for the treatment of patients with previously untreated BRAF wild-type advanced melanoma
24 November 2015 - First and only PD-1 immune checkpoint inhibitor approved as a single agent for first-line use in advanced BRAF wild-type melanoma.
Bristol-Myers Squibb Company today announced that the US FDA has approved Opdivo (nivolumab) injection, for intravenous use, as a single agent for the treatment of patients with BRAF V600 wild-type (WT) unresectable or metastatic melanoma.
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).
