GSK receives EU authorization for Mekinist

GlaxoSmithKline announced 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.


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Mekinist (trametinib) is used in treating patients with unresectable or metastatic melanoma with BRAF (a gene) 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-1. 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 tumors in BRAF-mutant metastatic melanoma.


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