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  • #22070
    Catherine Poole
    Keymaster

    The approval for Pembro (Merck) will be in October.

    The EAP for Nivo (BMS) is just opening with two locations you can find here: http://www.bms.com/studyconnect/Pages/ProtocolPage.aspx?govid=CA209-168,NCT02142218&zip=19343

    Also news on NIVO: http://www.mmm-online.com/bms-cuts-nivo-trial-short-eyes-approval-pathway/article/357867/

    #64889
    rosa11
    Participant

    Catherine,

    Are you talking about this October for FDA approval? And if so, are they going to keep the same requirement restrictions as the PD1 EAP?

    #64890
    Catherine Poole
    Keymaster

    Yes, they probably will keep the IPI restriction for the approval. I have lobbied against it to no avail. What will happen is oncologists can write it off label, but insurance may balk. So that’s the way it will be for 6 months at least until approval comes through for first line therapy.

    #64891
    rosa11
    Participant

    What about the BRAF inhibitor if someone tests positive for the mutation? Do you know if this will be a requirement like IPI?

    #64892
    RJoeyB
    Participant

    Also FYI, Merck announced yesterday that pembro has officially been accepted into and started the approval process in the EU by their regulating body:

    Merck’s Investigational Anti-PD-1 Antibody, Pembrolizumab, Under Regulatory Review in Europe for the Treatment of Advanced Melanoma – MarketWatch

    http://www.marketwatch.com/story/mercks-investigational-anti-pd-1-antibody-pembrolizumab-under-regulatory-review-in-europe-for-the-treatment-of-advanced-melanoma-2014-06-30” class=”bbcode_url”>http://www.marketwatch.com/story/mercks-investigational-anti-pd-1-antibody-pembrolizumab-under-regulatory-review-in-europe-for-the-treatment-of-advanced-melanoma-2014-06-30

    #64893
    Catherine Poole
    Keymaster

    Yes, thanks for that bit of new. It does NOT look like BRaf positive folks will have to do the braf therapy before they can take the PD1.

    #64894
    Steven
    Participant

    Hi Catherine – is the reason the FDA is requiring failing Ipi first because they are not convinced that PD1 is better than Ipi?

    #64895
    MathewR
    Participant

    I’ll speculate that Merck styled its submission with the ipi requirement because ipi is the standard of care and Merck does not (yet) have Phase III trial results demonstrating that PD-1 has better response rates (though it certainly seems to based on the earlier Phase trials). Merck is currently conducting that Phase III but the results probably won’t be available for some time.

    #64896
    Catherine Poole
    Keymaster

    Matt is absolutely correct. We’ve discussed this in another part of the forum. Until the phase III trials of PD1 vs. IPI are completed, the requirement will be to progress on IPI before you can be prescribed PD1. Now the issues with this include: folks with autoimmune disease who can’t do IPI, and research showing your response to PD1 is lessened if you have IPI first! What may end up being a royal pain is that folks will need off-label scripts to get PD1 and then fight with their insurance to pay for it. I’ve brought this to the attention of Merck and the FDA, but both seem in a place that they can’t change these regs.

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