The US Food and Drug Administration (FDA) granted approval for a combination therapy to treat unresectable or metastatic melanoma with BRAF mutations. Encorafenib (Braftovi) and binimetinib (Mektovi) are now approved in combination for the treatment of unresectable or metastatic melanomas with a BRAF V600E or V600K mutation, as detected by an FDA approved test.
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This approval is based on the randomized, active-controlled, open-label, multicenter COLOMBUS trial in which 577 patients with BRAF V600E or V600K mutations-positive unresectable or metastatic melanoma were randomized (1:1:1) to receive binimetinib (45 mg) twice daily plus encorafenib (450 mg) once daily, encorafenib (300 mg) once daily, or vemurafenib (960 mg) twice daily. The median progression-free survival was 14.9 months for patients receiving binimentinib plus encorafenib compared with 7.3 months for patients in the vemurafenib monotherapy arm. Overall response rates were 63% and 40%, respectively. Median duration of response was 16.6 months and 12.3 months, respectively.
The most common adverse effects in patients receiving the encorafenib and binimetinib combination were fatigue, nausea, diarrhea, vomiting, abdominal pain, and arthralgia. Discontinuation occurred in 5% of all patients receiving the combination, with hemorrhage and headache the most common reasons for discontinuation.
