GlaxoSmithKline (GSK) receives FDA approval in May 2013, for two orphan drugs for the treatment of patients with advanced or unresectable melanoma :
Both drugs are approved as single agents, not as a combination treatment. Tafinlar, a BRAF inhibitor, is approved for melanoma whose tumors express the BRAF V600E gene mutation. Mekinist, a MEK inhibitor, is approved for melanoma whose tumors express the BRAF V600E or V600K gene mutations. Both drugs are approved with a companion genetic test, ThxID BRAF test, made by France’s bioMérieux, which will help determine if a patient’s melanoma cells have the V600E or V600K mutation in the BRAF gene. About 50% of Melanomas arising in the skin have a BRAF gene mutation.
GSK announces on January 8, that the FDA gives the first combination oral targeted therapy, Tafinlar + Mekinist, accelerated approval for the treatment of unresectable or metastatic melanoma, with BRAF V600E or V600K mutations…
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