FDA Approves trametinib and dabrafenib for unresectable or metastatic BRAF-mutated melanoma

The U.S. Food and Drug Administration (FDA) has approved trametinib (MEKINIST tablet, GlaxoSmithKline, LLC), for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutation as detected by an FDA-approved test. Trametinib is not indicated for treatment of patients who have received prior BRAF inhibitor therapy.

The U.S. FDA approved dabrafenib (TAFINLAR capsule, GlaxoSmithKline, LLC), for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. Dabrafenib is not indicated for the treatment of patients with wild-type BRAF melanoma because of the potential risk of tumour promotion.

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