Mekinist cleared in Europe

The European Commission approves GlaxoSmithKline's (GSK) Mekinist (trametinib) for the treatment of patients with unresectable or metatstatic melanoma who have a BRAF V600 mutation. Before being treated with Mekinist, the clinician must confirm that the patient has the BRAF V600 mutation using a validated test.

Trametinib in an MEK inhibitor which blocks the activity of a protein kinase termed MEK. The protein is present in the MAPK pathway which regulates the normal growth and death of cells and plays a role in the development of metastatic melanoma. Some mutations in the BRAF gene cause the MEK protein to stimulate cancer cell growth and survival. Inhibiting MEK, therefore, can potentially slow down tumor growth in BRAF-mutant metastatic melanoma.

GSK in-licensed trametinib from Japan Tobacco in 2006 giving it worldwide exclusive rights to the product. Japan Tobacco has co-promotion rights in Japan.

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