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Zarnestra

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  • #7807
    Suzanne
    Member

    Someone mentioned in an earlier post that Zarnestra had been turned down by a committee at FDA for approval. I found out today at Hopkins that they had gone for a “fast track” approval for use as a chemo for older patients unable to go through induction and consolidation. The committee did recommend against that. Not against the drug. They are just recommending that phase 111 trials be completed prior to approval and my understanding is that those are well under way in Europe. Evidently there is pressure on the fast track approval because of some some drugs that were approved that way recently and then did not live up to the early promise when phase 111 trials were completed. I am reading recently of criticism of FDA for approving dugs too easily that later have problems so I am sure that is influencing the process at this point.
    My understanding is that papers are going to be presented and published soon on using Zarnestra the way I took it as a preventative against relapse in high risk cases.

    #7808
    Sandy L
    Member

    Good to know. Thanks for the update.

    #7809
    JulieMarie
    Member

    Suzzane,

    how do we find out about revlimid and the FDA approval that’s suppose to come this October? My mom is waiting for a clinical trial and we can’t find one here in the US.

    Thanks!

    #7810
    Suzanne
    Member

    My understanding is that when a drug is submitted for approval all the studies are closed and the results gathered for the application. It then is not available until the drug is approved unless you can find a study that is using the drug differently-ie dif dose, combined with another drug, different patient qualifying perameters. I don’t know if you can get it on a “compassionate need” basis.I think for that your doctor would have to contact the drug company or maybe NIH. Even once it is approved it can take months for it to be produced and made available. Wasn’t it Dr. List in Florida who did most of the work on revlimid? You or your doctor might try contacting him. Sometime Doc’s have better luck getting through to another Dr. when you are calling a place that is not treating you. .

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