GlaxoSmithKline files for EU and US approval for dabrafenib and trametinib

UK pharma giant GlaxoSmithKline (LSE: GSK) last week submitted regulatory filings in the European Union and USA 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, the company has filed:

• a 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;
• 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; and
• a NDA to the FDA for trametinib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutations as detected by an FDA-approved test.

If approved, the drugs would enter a market worth $1.5 billion by 2020