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Braftovi Plus Mektovi a New Combination for Unresectable or Metastatic Melanoma with BRAF Mutation

Web Exclusives - FDA Updates

On June 27, 2018, the FDA approved the combination of encorafenib and binimetinib (Braftovi and Mektovi; Array BioPharma), 2 new kinase inhibitors, for the treatment of patients with unresectable or metastatic melanoma and the BRAF V600E or BRAF V600K mutation, as detected by the companion diagnostic THxID BRAF Kit, which was approved on the same day.

The approval of this new combination was based on the randomized, active-controlled, open-label, multicenter clinical trial of 577 patients with unresectable metastatic melanoma and BRAF V600E or BRAF V600K mutation. Patients were randomized to the combination of binimetinib 45 mg twice daily plus encorafenib 450 mg once daily; monotherapy with encorafenib 300 mg once daily; or monotherapy with vemurafenib (Zelboraf) 960 mg twice daily—until disease progression or unacceptable toxicity.

The median progression-free survival was 14.9 months with the binimetinib plus encorafenib combination versus 7.3 months with vemurafenib monotherapy (P <.0001). The overall response rates were 63% and 40%, respectively, and the median response duration was 16.6 months with the combination and 12.3 months in the monotherapy arm.

The most common (≥25%) adverse reactions with the encorafenib and binimetinib combination were fatigue, nausea, diarrhea, vomiting, abdominal pain, and arthralgia. Hemorrhage and headache were the most common (5%) reasons for discontinuing therapy.

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Last modified: February 19, 2019