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The Food and Drug Administration has approved combination therapy of encorafenib (Braftovi) and binimetinib (Mektovi) for the treatment of unresectable or metastatic melanoma with BRAF V600E or BRAF V600K mutations; the FDA also has approved the THxID BRAF Kit as a companion diagnostic for this combination therapy.
The approval was based on results from the randomized, active-controlled, open-label, multicenter COLUMBUS trial, which included 517 patients. Progression-free survival, according to RECIST 1.1 criteria, was the major efficacy measure; the median progression-free survival was 14.9 months in the encorafenib/binimetinib combination arm versus 7.3 months in the vemurafenib (Zelboraf) monotherapy arm (hazard ratio, 0.54; 95% confidence interval, 0.41-0.71; P less than .0001).
Fatigue, nausea, diarrhea, vomiting, abdominal pain, and arthralgia were the most common adverse reactions. Discontinuation of therapy from adverse reactions occurred in 5% of patients receiving the combination, the FDA said in a press statement.
The full prescribing information for encorafenib and binimetinib can be found on the FDA website.
The Food and Drug Administration has approved combination therapy of encorafenib (Braftovi) and binimetinib (Mektovi) for the treatment of unresectable or metastatic melanoma with BRAF V600E or BRAF V600K mutations; the FDA also has approved the THxID BRAF Kit as a companion diagnostic for this combination therapy.
The approval was based on results from the randomized, active-controlled, open-label, multicenter COLUMBUS trial, which included 517 patients. Progression-free survival, according to RECIST 1.1 criteria, was the major efficacy measure; the median progression-free survival was 14.9 months in the encorafenib/binimetinib combination arm versus 7.3 months in the vemurafenib (Zelboraf) monotherapy arm (hazard ratio, 0.54; 95% confidence interval, 0.41-0.71; P less than .0001).
Fatigue, nausea, diarrhea, vomiting, abdominal pain, and arthralgia were the most common adverse reactions. Discontinuation of therapy from adverse reactions occurred in 5% of patients receiving the combination, the FDA said in a press statement.
The full prescribing information for encorafenib and binimetinib can be found on the FDA website.
The Food and Drug Administration has approved combination therapy of encorafenib (Braftovi) and binimetinib (Mektovi) for the treatment of unresectable or metastatic melanoma with BRAF V600E or BRAF V600K mutations; the FDA also has approved the THxID BRAF Kit as a companion diagnostic for this combination therapy.
The approval was based on results from the randomized, active-controlled, open-label, multicenter COLUMBUS trial, which included 517 patients. Progression-free survival, according to RECIST 1.1 criteria, was the major efficacy measure; the median progression-free survival was 14.9 months in the encorafenib/binimetinib combination arm versus 7.3 months in the vemurafenib (Zelboraf) monotherapy arm (hazard ratio, 0.54; 95% confidence interval, 0.41-0.71; P less than .0001).
Fatigue, nausea, diarrhea, vomiting, abdominal pain, and arthralgia were the most common adverse reactions. Discontinuation of therapy from adverse reactions occurred in 5% of patients receiving the combination, the FDA said in a press statement.
The full prescribing information for encorafenib and binimetinib can be found on the FDA website.