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Binimetinib/Encorafenib Combo Approved in Europe for BRAF+ Melanoma

Jason M. Broderick @jasoncology
Published: Thursday, Sep 20, 2018

Ron Squarer

Ron Squarer
The European Commission has approved the combination of the BRAF inhibitor encorafenib (Braftovi) and the MEK inhibitor binimetinib (Mektovi) for the treatment of adult patients with BRAF V600–mutant unresectable or metastatic melanoma, according to Array BioPharma, the company developing the regimen.

The approval is based on the phase III COLUMBUS trial, in which at a median follow-up of 36.8 months, combining encorafenib at 450 mg daily and binimetinib at 45 mg twice daily (COMBO450) reduced the risk of death by 39% versus vemurafenib (Zelboraf) monotherapy. The median overall survival (OS) was 33.6 months (95% CI, 24.4-39.2) versus 16.9 months (95% CI, 14.0-24.5), respectively (HR, 0.61; 95% CI 0.47-0.79; <.0001).

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