FDA Approval of Adjuvant Dabrafenib/Trametinib in BRAF+ Melanoma

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The FDA has granted an approval to dabrafenib combined with trametinib as an adjuvant treatment for patients with BRAF V600E- or V600K-positive stage III melanoma following complete resection.

The approval is based on findings from the phase III COMBI-AD study, in which adjuvant treatment with dabrafenib and trametinib reduced the risk of relapse or death by 53% compared with placebo for patients with BRAF-mutant stage III melanoma.

After a median follow-up of 2.8 years, the 3-year relapse-free survival rate with dabrafenib and trametinib was 58% compared with 39% for placebo.

The median relapse-free survival was not reached with the combination versus 16.6 months for placebo; however, RFS was improved with dabrafenib plus trametinib across all subgroups.

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