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FDA approves GSK melanoma drugs

May 30, 2013 12:13 AM UTC

FDA approved a pair of NDAs from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) for Tafinlar dabrafenib and Mekinist trametinib as monotherapies to treat metastatic or unresectable melanoma. Tafinlar, an oral BRAF protein kinase inhibitor, is approved to treat melanoma with BRAF V600E mutations as detected by an FDA-approved test. Mekinist, a small molecule inhibitor of MAP kinase kinase 1 ( MAP2K1; MEK1) and MEK2, is approved to treat melanoma with BRAF V600E or V600K mutations. Mekinist is the first MEK inhibitor to be approved by FDA. GSK plans to launch both drugs in the U.S. by early next quarter. The pharma said the wholesale acquisition cost (WAC) for a one-month supply of Tafinlar is $7,600, while the WAC for a one-month supply of Mekinist is $8,700.

FDA also approved a PMA from GSK's partner bioMerieux S.A. (Euronext:BIM) for a companion diagnostic, THxID BRAF test, to detect BRAF V600E and V600K mutations. GSK partnered with bioMerieux to develop a companion diagnostic in 2010. bioMerieux was down EUR 0.07 to EUR 75.20 on Wednesday. The approvals came after market close in France. ...