Trials & Filings

GSK Melanoma Combo Gets Approval

Accelerated review contingent on Phase III study

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

GlaxoSmithKline has received approval from the FDA for Mekinist (trametinib) for use in combination with Tafinlar (dabrafenib) for the treatment of patients with unresectable melanoma (melanoma that cannot be removed by surgery) or metastatic melanoma (melanoma which has spread to other parts of the body) with BRAF V600E or V600K mutations. These mutations must be detected by an FDA-approved test. The approval of the combination is based on the demonstration of response rate and median duration...

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