GSK Announces Submissions in the EU and US for Dabrafenib and Trametinib

GSK has announced regulatory submissions in the EU and US related to single-agent use of its BRAF inhibitor dabrafenib and MEK inhibitor trametinib.

GlaxoSmithKline has announced regulatory submissions in the European Union and United States (US) related to single-agent use of its BRAF inhibitor dabrafenib and MEK inhibitor trametinib to treat patients with BRAF V600 mutation positive metastatic melanoma, specifically:

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

· A New Drug Application to the US 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.