Combo Therapy for Advanced BRAF-Mutant Melanoma Gets FDA Approval

Officials with the FDA have approved Array BioPharma’s encorafenib (Braftovi) capsules in combination with binimetinib (Mektovi) tablets for the treatment of patients with unresectable or metastatic melanoma with BRAFV600E or BRAFV600K mutation, according to a press release.

Approximately half of the 200,000 cases of melanoma diagnosed each year have BRAF mutations, according to Array BioPharma. Despite recent advances in treatment, there remains an unmet need for therapies that are effective and well-tolerated for patients with BRAF-mutant melanoma.

Encorafenib is an oral small molecule BRAF kinase inhibitor and binimetinib is an oral small molecule MEK inhibitor that target key enzymes in the MAPK signaling pathway.

The approval is based on results from the phase 3 COLUMBUS trial evaluating the efficacy and safety of the combination therapy compared with vemurafenib and encorafenib monotherapy. The trial included 921 patients with locally advanced, unresectable, or metastatic melanoma with BRAFv600 mutation.

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