Categorized | Melanoma News, Regulatory

Melanoma: FDA Approves Adjuvant Dabrafenib With Trametinib

Source: Cancer Therapy Advisor, May 2018

The US Food and Drug Administration (FDA) approved dabrafenib with trametinib as an adjuvant therapy following complete resection for patients with BRAFV600E or V600K-mutated melanoma with lymph node involvement, according to a press release.1
The FDA based its approval on results from the phase 3 COMBI-AD study (ClinicalTrials.gov Identification: NCT01682083), for which researchers randomly assigned 870 patients with advanced, high-risk melanoma after complete resection to receive dabrafenib 2 mg once daily plus trametinib 150 mg twice daily or placebo.
After a median follow-up of 2.8 years, the 3-year relapse-free survival rate was 58% vs 39% among patients in the combination therapy group vs placebo group, respectively (hazard ratio [HR], 0.47; 95% CI, 0.39-0.58; P < .001), representing a 53% reduced risk of disease recurrence or death.
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