The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of 8 January 2014 for the Mekinist (trametinib) supplement and 9 January 2014 for the Tafinlar (dabrafenib) supplement.
The applications are based on data from a randomized 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.
Use of dabrafenib and trametinib in combination is investigational and not approved anywhere in the world. On 7 February 2013, GSK announced European regulatory submission for the combined use of dabrafenib and trametinib adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation and the review is ongoing according to standard timelines.
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