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Exelixis, Inc. Message Board

  • wilderguide wilderguide Sep 16, 2013 7:10 PM Flag

    Dabrafenib/Trametinib combo gets FDA priority review

    $$$$
    Onclive today 9/16/13
    Looks like that aggressive strategy might just pay off...
    I'm curious to see if Roche has a response to this announcement.

    "The FDA has granted Priority Review designation to dabrafenib (Tafinlar) and trametinib (Mekinist) as a combination treatment for patients with unresectable or metastatic melanoma with a BRAFV600E/K mutation.

    According to a statement from the drugs’ manufacturer, GlaxoSmithKline, the FDA has set target dates in early January 2014 to review the trametinib and dabrafenib supplements.

    The Priority Review was granted based on the results of a randomized phase I/II study that compared combination therapy with dabrafenib and trametinib to dabrafenib monotherapy in adult patients with BRAFV600E/K mutation-positive metastatic melanoma."
    GLTA

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    • wilderguide I came across this when looking into the BRAF V600 Mutation.It maybe old but never the less here it is:So lots of competiton and hope like you the Roche/Genentech/Exelixis gets a piece of the pie?
      BRAF V600 Mutation Target of New Melanoma Therapy
      Tuesday, 22 February 2011 16:21

      Research continues for a new drug to treat malignant melanoma - the most aggressive, deadliest forms of skin cancer.

      In January, drug development partners Plexxikon and Roche/Genentech announced that late-stage data from a clinical study of RG7204 (PLX4032) met its co-primary endpoints showing significant survival rates in people with previously untreated BRAF V600 mutation-positive metastatic melanoma. According to the Phase III data, study participants who received RG7204 lived longer and also lived longer without disease progression compared to participants who received dacarbazine, the current standard of care.

      RG7204, an orally available inhibitor of mutated BRAF, is designed to selectively inhibit the mutated BRAF protein found in approximately 50% of all cases of metastatic melanoma.

    • Is GDC-0973 (XL518) targeting the same pathway? Are they both suppose to inhibit MEK in RAS or the BRAF mutant tumors.? Or are they both suppose to work for somewhat different types of melanoma or the same?For GDC-0973 (XL518), it says, patients with locally advanced/unresectable or metastatic melanoma carrying a BRAFV600 mutation.For the GSK it says patients with unresectable or metastatic melanoma with a BRAFV600E/K mutation. One has E/K and the other dosen't?Thanks wilderguide.

      • 1 Reply to clemcaldwell
      • $$$$
        Hi Clem,
        I do see GSK's BRAF/MEK combination trial in advanced, metastatic melanoma as direct competition for the Roche sponsored trial in MM that has BRAF inhibitor Zelboraf (vemurafenib) in combination with GDC-0973 (cobimetinib). From my perspective, GSK getting priority review with a target review date of January 2014 is not good news for Exelixis.
        Conversely, I do not see that all is necessarily lost. Earlier this month, Roche reopened the co Brim P1 combination trial to recruitment. ..and the P3 trial is still recruiting like gangbusters. Should the supplemental reviews for Dabraf & Tramet somehow go awry, or - as Joeflow has pointed out - additive toxicities manage to confound the review process...Roche will have additional data in readiness for a subsequent submission. At this point, as both their drugs are approved, GSK has a decided advantage. With this priority review, they might have the additional advantage of first consideration for dual SNDA filings. If Roche has made any attempt to differentiate their trial from GSK's... I am unaware of it.
        We are witnessing a corporate game of musical chairs, and i hope we have a place to sit when the music stops.
        GLTA

    • saw this earlier today. leave it to wilder to post it. thanx

    • GSK still has to show A+B is more effective than A or B alone AND keep AEs at acceptable levels. not a simple thing to do if AEs turn out to be synergistic and A+B is additive. Priority review can be a double-edged sword. GSK could just as easily get bad news as good news - it would just happen faster with a priority review.

      took a new position - biomarkers of immunomodulation in cancer therapeutics. really exciting stuff.
      can't really talk about it.

      Joe

    • A phase I/II of A+B v A is enuf for a combo to be approved, that's good.

 
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