Bristol-Myers Squibb’s Opdivo has won accelerated approval in the US in combination with Yervoy as a treatment for patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma.
Clearance of the regimen - the first and only FDA-approved combination of checkpoint inhibitors - was issued after clinical trials showed superior progression-free survival (PFS) compared with Yervoy (ipilimumab) alone, and expands the original indication by including patients regardless of BRAF mutational status.
In the CheckMate-067 study, median PFS was 11.5 months for the Opdivo(nivolumab)/Yervoy arm and 6.9 months for Opdivo, versus 2.9 months for Yervoy. The combination also demonstrated a 58% reduction in the risk of disease progression compared to Yervoy, while Opdivo cut the risk by 43%.
US regulators expanded Opdivo’s use as a single-agent to include previously untreated BRAF mutation-positive advanced melanoma patients.
Use of the drug as a single-agent in patients with BRAF V600 mutation-positive unresectable or metastatic melanoma is cleared under accelerated approval, while its use in previously untreated patients with BRAF V600 wild-type unresectable or metastatic melanoma by OK’d by the FDA in November last year.