Regulatory Update – GSK announces submissions in the EU and US for dabrafenib and trametinib

GlaxoSmithKline (GSK) plc today 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.
• A New Drug Application to the US 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.

“These regulatory submissions represent important progress in our Oncology pipeline.” said Dr. Rafael Amado, Head of Oncology R&D at GSK “We are planning to submit an application to the European Medicines Agency for trametinib in BRAF V600 mutation positive metastatic melanoma in the coming months.”

GSK entered a collaboration with bioMérieux (aworld leader in in vitro diagnostics, bioMérieux ) in 2010 to develop a molecular theranostic test to detect BRAF V600 (V600E and V600K) gene mutations found in several cancers, including melanoma. bioMérieux has filed for FDA Pre-Market Approval of the test and it is currently being utilised in the Phase III trametinib-dabrafenib combination programme to identify appropriate patients.