European Commission approves Braftovi + Mektovi for metastatic melanoma with a BRAFV600 mutation. Array Biopharma + Pierre Fabre

Array BioPharma Inc. announced that the European Commission (EC) has approved Braftovi in combination with Mektovi for the treatment of adult patients with unresectable or metastatic melanoma with a BRAFV600 mutation, as detected by a validated test. This approval is applicable to all 28 European Union (EU) member states, as well as Liechtenstein , Iceland and Norway . The EC approval is based on results from the Phase III COLUMBUS trial, of which the primary endpoint was median progression-free survival (mPFS). Braftovi + Mektovi achieved an mPFS of nearly 15 months [14.9 months versus vemurafenib monotherapy at 7.3 months; hazard ratio (HR) 0.54 (95% CI, 0.41�0.71), p<0.0001].>

Braftovi + Mektovi is the first targeted treatment to achieve over 30 months median overall survival (OS). As published in The Lancet Oncology in September 2018, Braftovi + Mektovi reduced the risk of death compared to vemurafenib [HR (0.61), (95% CI 0.47,0.79), p <0.0001]. median os was 33.6 months for patients treated with the combination compared to 16.9 months for patients treated with vemurafenib.>