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Orphan Drugs: GlaxoSmithKline’s Combo Melanoma Treatment

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GlaxoSmithKline (GSK) receives FDA approval in May 2013, for two orphan drugs for the treatment of patients with advanced or unresectable melanoma :

•   Tafinlar (Dabrafenib)

•   Mekinist (Trametinib).

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.

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