Posted by Michael Wonder on 08 Jun 2017
Bristol-Myers Squibb receives approval from the US FDA for the Opdivo (nivolumab) + Yervoy (ipilimumab) regimen in BRAF V600 wild-type unresectable or metastatic melanoma
30 September 2015 - First and only FDA approved combination of two immuno-oncology agents.
Bristol-Myers Squibb Company today announced that the US FDA approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab), for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.
Today’s announcement marks the first and only FDA approval of a Regimen of two Immuno-Oncology agents in cancer. This indication is approved under accelerated approval based on tumour response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
