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Dabrafenib/Trametinib Combo Receives ‘Priority Review’ Designation for Treatment of Metastatic Melanoma
Approval decision set for January 2014 (September 16)
The FDA has granted a Priority Review designation to supplemental New Drug Applications (sNDAs) for the combined use of Tafinlar (dabrafenib, GlaxoSmithKline) and Mekinist (trametinib, GSK) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 E or K mutation.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of January 8, 2014 for the trametinib supplement and January 9, 2014 for the dabrafenib supplement.
The applications are based on data from a randomized phase I/II study of combination therapy with dabrafenib and trametinib versus dabrafenib monotherapy in adult patients with BRAF V600E and V600K mutation-positive metastatic melanoma.
Source: GSK; September 16, 2013.