NICE Fast-Tracks Approval for BMS's Opdivo

June 17, 2016

June 17, 2016.

Bristol-Myers Squibb (BMS) reports that the National Institute for Health and Care Excellence (NICE)’s recommendation of the combination therapy of Opdivo to treat UK NHS patients with advanced skin cancer is one of the fastest approvals from NICE to date, issued just weeks after the combination was licensed by the European Commission on May 11 this year.

BMS states that the NICE decision was supported by data from a Phase III clinical study, in which some patients treated with the combination therapy saw their cancer kept at bay for almost four times longer than those treated with ipilimumab alone, regardless of BRAF gene mutational status.