Categorized | Melanoma News, Regulatory

FDA Grants Adjuvant Dabrafenib/Trametinib Priority Review for BRAF + Melanoma

Source: OncLive, December 2017

The FDA has granted a priority review to a supplemental new drug application (sNDA) for the use of dabrafenib (Tafinlar) combined with trametinib (Mekinist) as an adjuvant treatment for patients with BRAF V600E– or V600K–positive stage III melanoma following complete resection.
The sNDA 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.1,2 After a median follow-up of 2.8 years, the 3-year relapse-free survival (RFS) rate with dabrafenib and trametinib was 58% compared with 39% for placebo (HR, 0.47; 95% CI, 0.39-0.58; P <.001). The priority review follows an FDA breakthrough therapy designation granted to the combination in October 2017 for use in this setting. Under the priority review, the FDA will issue its decision on the sNDA within 6 months of the application submission, as opposed to the 10-month standard review. [button link="" window="yes"]read the original full article[/button]