FDA Approves Combination Therapy for Melanoma


The FDA has approved dabrafenib (Tafinlar) and trametinib (Mekinist) in combination for the adjuvant treatment of patients with BRAF V600E or V600K melanoma mutations, detected by an FDA-approved test, and with involvement of 1 or more lymph nodes following complete resection. Under the combination therapy regimen, patients receive 150 mg of dabrafenib orally 2 times per day with 2 mg of trametinib orally once per day until disease recurrence or unacceptable toxicity for up to 1 year.

Approval of this combination treatment was based on an international, multi-center, randomized, double-blind, placebo-controlled trial that included 870 participants with stage 3 melanoma with BRAF V600E or V600K mutations and pathologic involvement of regional lymph nodes. The study showed that participants who received combination treatment had statistically significant improvement in relapse-free survival (RFS) compared with those who received placebo. However, the estimated median RFS was not reached for participants who received combination therapy compared with placebo at 16.6 months.
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Common adverse events included pyrexia, fatigue, nausea, headache, rash, chills, diarrhea, vomiting, arthralgia, and myalgia. Discontinuation of treatment, dose reduction, or dose interruption of dabrafenib and trametinib was commonly associated with pyrexia and chills, as well as decreased ejection fraction for trametinib.