Home Forums Melanoma Diagnosis: Stage IV Good News: EAP opening for Nivo/IPI combo

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  • #22088
    Catherine Poole
    Keymaster

    Of course for naive patients: NCT02186249 on clinicaltrials.gov or go to: http://clinicaltrials.gov/ct2/results?term=NCT02186249&Search=Search

    Locations aren’t posted yet, but will as soon as the centers get approvals, could be as long as 8 weeks.

    #64969
    MathewR
    Participant

    Catherine, any info on whether this means that BMS is seeking FDA approval for this combination (instead of nivo only after ipi failure)?

    #64970
    Anonymous
    Guest

    This is really good news.

    Smart move by BMS and I’m sure they’re going for the combo to be a standard of care. Afterall why not sell two drugs instead of one.

    The trial data I saw was compelling. SAs were kinda rough though they appeared to be quite managable like those for IPI.

    Jeff

    #64971
    Catherine Poole
    Keymaster

    Matt: no idea, but I imagine they will ask for that combo to be allowed, but that is always top secret by both pharma and FDA as to what is going for approval. I did hear that with this combo the sides affects as Jeff mentioned were pretty pronounced and immediate. But hopefully they’ve learned from the trial and can mitigate.

    #64972
    Catherine Poole
    Keymaster
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