GlaxoSmithKline files sNDAs for combination melanoma drugs

UK pharma giant GlaxoSmithKline (LSE: GSK) said today (July 9) that it has submitted supplemental New Drug Applications (sNDAs) to the US Food and Drug Administration for use of Tafinlar (dabrafenib), a BRAF inhibitor, in combination with Mekinist (trametinib), a MEK inhibitor.

Supplemental applications were submitted to each of the currently approved NDAs for the use of each drug in combination with the other, for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 E or K mutation. The two drugs have recently been individually approved by the FDA for the treatment of metastatic melanoma (The Pharma Letter May 30, 2013).

The applications are based on data from a randomized Phase I/II study comparing dabrafenib monotherapy to combination therapy with dabrafenib and trametinib in patients with BRAF V600E and V600K mutation positive metastatic melanoma. It had been expected by analysts that GSK would not file the sNDAs until it had Phase III clinical data is expected.