GSK receives EU marketing authorisation for Mekinist (trametinib) for patients with unresectable or metastatic melanoma with a BRAF V600 mutation

EMA

GlaxoSmithKline plc today announced that the European Commission (EC) has granted marketing authorisation for Mekinist (trametinib) as a single agent in the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. Trametinib has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy. Before taking trametinib, patients must have confirmation of a BRAF V600 mutation using a validated test.

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.

For more details, go to: http://www.gsk.com/media/press-releases/2014/gsk-receives-eu-marketing-authorisation-for-mekinist--trametinib.html

Michael Wonder

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Michael Wonder

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