Monday, September 16, 2013

GSK gets priority review from USFDA for dabrafenib/trametinib combination in metastatic melanoma

GlaxoSmithKline plc today announced that the US Food and Drug Administration (FDA) has granted Priority Review designation to its supplemental New Drug Applications (sNDAs) for combined use of Tafinlar® (dabrafenib - BRAF inhibitor) and Mekinist® (trametinib - MEK inhibitor) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 E or K mutation. The priority review was accepted as the combination has demonstrated an unprecedented 12 month survival benefit in patients with unresectable metastatic melanoma. 

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.  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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