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FDA Grants Priority Review Designation for Dabrafenib/Trametinib Combination in Metastatic Melanoma

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GlaxoSmithKline recently announced that the U.S. Food and Drug Administration has granted Priority Review designation to its supplemental New Drug Applications for the combined use of dabrafenib (Tafinlar) and trametinib (Mekinist) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E/K mutation. Use of dabrafenib and trametinib in combination is investigational and not approved anywhere in the world. 

The FDA has assigned a Prescription Drug User Fee Act target date of January 8, 2014, trametinib supplement and January 9, 2014, for the 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.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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