On April 30, 2018, the Food and Drug Administration (FDA) granted regular approval for the combination therapy of dabrafenib and trametinib for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. The approval was based upon NCT01682083, an international, randomized, double-blind, multicentre, placebo-controlled trial. This trial consisted of 876 patients with stage III melanoma with BRAF V600E or V600K mutations and pathological involvement of regional lymph nodes.
50% of the patients were arbitrarily assigned to receive dabrafenib (150 mg twice daily) in combination with trametinib (2 mg once daily) or two placebos for up to 1 year. The chief effectiveness result was relapse-free survival (RFS). RFS was demarcated as the time from randomization to…
