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FDA Approvals, News & UpdatesMelanomaNewsworthy

Braftovi plus Mektovi a New Combination for Metastatic Melanoma with BRAF Mutation

October 2018 Vol 4 No 5

In June 2018, the FDA approved 2 new drugs Braftovi and Mektovi (encorafenib and binimetinib; from Array BioPharma) to be used in combination for the treatment of patients with unresectable (can’t be removed by surgery) or metastatic (spreading) melanoma and a BRAF V600E or V600K mutation. At the same time, the FDA also approved the THxID-BRAF kit, which is a test to identify a BRAF mutation. Patients should have this new genetic test to identify the BRAF mutation before using this new targeted drugs combination.

The FDA approved this new combination based on a clinical trial of 577 patients with unresectable or metastatic melanoma and BRAF V600E or BRAF V600K mutation. The results showed that the average time without disease progression was 14.9 months with the new combination compared with only 7.3 months with another drug, Zelboraf (vemurafenib), which was previously approved for patients with melanoma.

The most common side effects with the new combination were fatigue, nausea, diarrhea, vomiting, abdominal pain, and joint inflammation. A few patients (5%) discontinued treatment with the new drugs because of bleeding and headache.

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Last modified: October 27, 2018

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