publication date: Sep. 21, 2018
Drugs & Targets
European Commission approves Braftovi + Mektovi for advanced BRAF-mutant melanoma
European Commission 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 member states, as well as Liechtenstein, Iceland and Norway.
It is sponsored by Array BioPharma Inc.
The EC approval is based on results from the Phase 3 COLUMBUS trial, of which the primary endpoint was median progression-free survival. 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.
Detailed recommendations for the use of these products in the EU are described in the summary of product characteristics, which are published in the European public assessment report and made available in all official EU languages.
Array has exclusive rights to Braftovi + Mektovi in the U.S. and Canada. Array has granted Ono Pharmaceutical exclusive rights to commercialize both products in Japan and South Korea, Medison exclusive rights to commercialize both products in Israel and Pierre Fabre exclusive rights to commercialize both products in all other countries, including Europe, Latin America and Asia (excluding … Continue reading European Commission approves Braftovi + Mektovi for advanced BRAF-mutant melanoma
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