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The 27 New Drugs Approved by the FDA in 2013


14 of 20

Mekinist for metastic melanoma

Mekinist product insert


Mekinist, marketed by GlaxoSmithKline, was approved May, 29, 2013, for the treatment of metastatic melanoma in adults with melanomas when the V600E or V600K mutations are present.

About 85% of patients with advanced melanomas carry the V600E mutation and about 10% carry the V600K mutation.

According to an efficacy trial of 322 patients, patient volunteers that received Mekinist delayed  tumor growth by 3.3 months when compared topatients on chemotherapy. Patients who had previously been treated with Tafinlar, GSK's other skin cancer drug treatment, did not appear to benefit from Mekinist.

Generic name: trametinib

FDA Announcement: FDA approves two drugs, companion diagnostic test for advanced skin cancer

Product website: mekinist.com

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  5. Mekinist is a drug treatment for metastic or inoperable melanomas.

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