Positive developments for GSK's Tafinlar/Mekinist and Arzerra

UK pharma giant GlaxoSmithKline (LSE: GSK) has announced positive news relating to three of its drugs, Tafinlar (dabrafenib), Mekinist (trametinib) and Arzerra (ofatumumab) over the past few days in terms of the products US regulatory process.

Firstly, GSK said 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 and Mekinist 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 Mekinist supplement and January 9, 2014, for the Tafinlar 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.