Categorized | Melanoma News, Regulatory

Dabrafenib/Trametinib Granted Priority Review for Stage III BRAF-Mutated Melanoma

Source: Cancer Network, January 2018

The US Food and Drug Administration (FDA) has granted priority review to the combination of dabrafenib (Tafinlar) and trametinib (Mekinist) for the adjuvant treatment of patients with stage III melanoma with BRAF V600E or V600K mutations after complete disease resection. The combination was granted Breakthrough Therapy designation earlier this year.
The FDA’s decision was based on data from the COMBI-AD phase III study evaluating the drug combination presented at the 2017 European Society for Medical Oncology (ESMO) Congress. Results presented there showed that 1 year of combination treatment reduced the risk for disease recurrence or death by 53% among this patient population.
The study included 870 patients with treatment-naive disease. All patients were within 12 weeks of resection and were randomly assigned to the combination of dabrafenib 150 mg twice daily plus trametinib 2 mg once daily or placebo. Treatment was given for 1 year.
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