Posted from: Monday, December 28, 2015 - 11:03 AM - Present

Updated Approval for Tafinlar and Mekinist

November 20, 2015 – The U.S. Food and Drug Administration (FDA) approved Mekinist (trametinib) and Tafinlar (dabrafenib) as combination therapy to treat patients with advanced melanoma that has metastasized or that cannot be surgically removed, and that has been tested as positive for specific genetic mutations – BRAF V600E or BRAF V600K. Tafinlar and Mekinist are manufactured by for GlaxoSmithKline. Mekinist and Tafinlar are oral kinase inhibitors; Mekinist inhibits MEK and Tafinlar inhibits BRAF. In January 2014, Mekinist and Taflinar originally received accelerated approval and this new regular approval was based on two, Phase III studies that confirmed the combination improved overall survival and progression-free survival compared to Tafinlar alone. In the COMBId trial, treatment with Mekinist plus Tafinlar improved overall survival by 6.4 months compared to Tafinlar alone (25.1 months versus 18.7 months). In the COMBIv trial, the combination improved progression-free survival by 4.1 months compared to Tafinlar alone (11.4 months versus 7.3 months). 

 

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Last Updated Saturday, December 09, 2017 - 10:10 PM.