GSK Makes Submissions In EU, US For Dabrafenib, Trametinib

LONDON--Pharmaceutical company GlaxoSmithKline PLC (GSK.LN) Friday announced regulatory submissions in the European Union and United States related to single-agent use of its BRAF inhibitor dabrafenib and MEK inhibitor trametinib to treat patients with BRAF V600 mutation positive metastatic melanoma.

MAIN FACTS:

-Specifically submitted:

* Marketing Authorization Application to the European Medicines Agency for dabrafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

* New Drug Application to the U.S. Food and Drug Administration for dabrafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutation as detected by an FDA-approved test.

* A New Drug Application to the U.S. Food and Drug Administration for trametinib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutations as detected by an FDA-approved test.