GlaxoSmithKline plc (GSK,GSK.L) Wednesday said the U.S. FDA approved both Tafinlar (dabrafenib) and Mekinist (trametinib).
Tafinlar is indicated as a single-agent oral treatment for unresectable melanoma (melanoma that cannot be removed by surgery) or metastatic melanoma (melanoma which has spread to other parts of the body) in adult patients with BRAF V600E mutation. Tafinlar is not indicated for the treatment of patients with wild-type BRAF melanoma.
Mekinist is indicated as a single-agent oral treatment for unresectable or metastatic melanoma in adult patients with BRAF V600E or V600K mutations. Mekinist is not indicated for the treatment of patients who have received a prior BRAF inhibitor therapy.
GSK will be making Tafinlar and Mekinist available for prescription no later than in the early third quarter of 2013.
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