FDA Approvals : Episode 7


FDA Approval of Adjuvant Dabrafenib/Trametinib in BRAF+ Melanoma

Hello and welcome to OncLive News Network, Breaking News. I'm Gina Columbus.

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.

For more breaking news, subscribe to email alerts from OncLive.com. Thank you for watching! I'm Gina Columbus.

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