BRIEF—Bristol-Myers picks up melanoma approval for Opdivo in the USA

Bristol-Myers Squibb has received another US FDA approval for Opdivo (nivolumab), for the adjuvant treatment of certain melanoma patients who have undergone complete resection.

The approval was based on data from the CheckMate-238 trial, in which the therapy bettered the recurrence-free survival (RFS) rate of stablemate Yervoy (ipilimumab).

RFS at 18 months was 66.4% compared with 52.7% for Yervoy.

This benefit was observed across subgroups, including in both BRAF mutant and BRAF wild-type patients.

Approximately three in every 10 patients with stage III melanoma currently receive adjuvant therapy after surgery.