GlaxoSmithKline plc (GSK) reports that the European Commission (EC) has granted marketing authorization for Mekinist (trametinib) as a single agent in the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

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

Mekinist was in-licensed by GSK in 2006. GSK holds the worldwide exclusive rights to develop, manufacture and commercialise Mekinist, while Japan Tobacco retains co-promotion rights in Japan. The drug was approved by the US Food and Drug Administration in 2013.

Source: GlaxoSmithKline