Home Forums Melanoma Diagnosis: Stage IV Great News!! GSK BRAF/MEK Approved by FDA

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    Catherine Poole

    Here’s the press release! Two GSK melanoma drugs get FDA approval


    Release posted by Phila Business Journal/ Research Park Triangle Journal a few minutes ago.




    GlaxoSmithKline received FDA approval for two melanoma drugs on Tuesday

    Lauren K. Ohnesorge

    Staff Writer- Triangle Business Journal

    Two new drugs to treat advanced skin cancer, Tafinlar (dabrafenib) and Mekinist (trametinib), nabbed Food and Drug Administration approval on Tuesday. Both drugs have Triangle links, as does a test that received companion approval.

    The drugs, developed by GlaxoSmithKline (NYSE: GSK), specifically treat melanoma, the leading cause of death from skin disease.

    Tafinlar and Mekinist have each been approved to treat patients whose tumors express certain gene mutations. Additionally, a new genetic test, THxID BRAF has been approved to detect the mutations in patients.

    The National Cancer Institute estimates nearly 77,000 Americans will be diagnosed with melanoma and nearly 9,500 will die from the disease in 2013.

    GSK has its North American headquarters in Research Triangle Park. The THxID BRAF Kit is manufactured by bioMérieux of Grenoble, France. The company also has a Durham footprint.


    Hooray for Glaxo!

    Having more options is a really good thing. :D

    Catherine Poole

    Absolutely, happy day. The dual therapy of braf/mek has not been approved yet, but the application is in and should happen soon. These were approved as single agents. I will tell you more as I learn about it. ASCO is certainly going to focus on this breakthrough and melanoma will be in the limelight and deservingly so after 40 years of nothing much to offer.


    The medical community is so darn close to getting a handle on this. Now if they can only figure out how it manages to outsmart these drugs.


    In the United States, the wholesale acquisition cost of Tafinlar is $7,600 for a 30-day supply and Mekinist will be $8,700 for a 30-day supply, according to a spokesperson for GlaxoSmithKline.

    Read more: UPDATED: GlaxoSmithKline gains FDA OK on two genetically targeted melanoma drugs – FierceBiotech http://www.fiercebiotech.com/story/glaxosmithkline-gains-fda-ok-two-genetically-targeted-skin-cancer-drugs/2013-05-29#ixzz2UivZHflI


    Do MEK inhibitors do anything for BRAF wild type people? Maybe if you are BRAF WT but NRAS+? Maybe some MEK inhibitors only? I can’t seem to get a handle on this. I do see that this one is approved only for treatment of BRAF mutations, although that doesn’t necessarily mean it doesn’t have some effect elsewhere.


    Another bullet for the arsenal, can’t complain about that! :D

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