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US priority review for GSK's melanoma combo

Daily News | September 17, 2013

Selina McKee

US priority review for GSK's melanoma combo

US regulators are carrying out a speedy review of the combined use of GlaxoSmithKline's skin cancer drugs Tafinlar (dabrafenib) and Mekinist (trametinib).

The US Food and Drug Administration will assess the safety and efficacy of combining these two drugs to treat adult patients with unresectable or metastatic melanoma with a BRAF V600 E or K mutation.


The filings are based on data from a randomised Phase I/II study comparing combination therapy with dabrafenib and trametinib to dabrafenib monotherapy in adult patients with BRAF V600E and V600K mutation positive metastatic melanoma.


It is hoped that combining these two drugs, which have very different modes of action, will magnify their effect and thus help to boost progression free survival.


A priority review in the US means that GSK will have a decision from the FDA in early January.


The combo has not yet been approved anywhere in the world, but the US cleared the individual drugs back in May, while in Europe Tafinlar was approved earlier this month; the EMA's review of Mekinist, and the dual use of these two drugs, is still ongoing.


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