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GSK wins big with Two FDA approvals in Melanoma

Authored by James Sheppard

GSK were celebrating when the FDA announced they had approved two drugs for melanoma. The pair of drugs, dabrafenib and trametinib come with a diagnostic test that can be used to identify patients most likely to respond to treatments.

Dabrafenib and trametinib will now go on to be sold as Tafinlar and Mekinist respectively. The companion diagnostic that goes with the drugs will marketed as THxID BRAF test. In the US GSK have announced that the wholesale cost of purchasing Tafinlar will be around $7600 for a 30 day supply and Mekinist will be $8700 for a 30 day supply.

At the beginning of 2013 GSK had 5 drugs under regulatory review, including these two drugs. The dual approval will give the pharma giant a much needed boost after turning around its R&D efforts more than 3 years ago. Analysts believe that peak sales for these two drugs will be around $3.56bn each.

GSK also signalled its intent to continue developing the drugs by suggesting a new combination approach which could delay the recurrence in high risk patients. The trials come at a time when GSK is racing Roche/Genentech to advance combination therapies against melanoma. Genetech is currently undertaking late stage testing on a dual therapy consisting of a MEK inhibitor, from partner Exelixis and is approved drug Zelboraf.

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