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  • Masitinib

    Posted by Deleted User on July 20, 2021 at 8:10 pm

    Masitinib, Given Early in ALS Course, Extends Life, Trial Data Show

    Masitinib is now the darling of the moment. My ?? There is no reason that this drug is not moved up and approved now by the FDA for ALS? 75 months is a long time to validate the safety of the drug, and the results are better than Riluzole and Radicava. Why do we have to wait any longer!

    jean-pierre-le-rouzic replied 2 years, 8 months ago 2 Members · 2 Replies
  • 2 Replies
  • jean-pierre-le-rouzic

    Member
    July 21, 2021 at 1:09 am

    There is no reason that this drug is not moved up and approved now by the FDA for ALS?

    John, I do not understand what data is impressive here.

    If you look at the figure 2 in the scientific publication you will see that there is a 3% difference between placebo group and groups that received Masitinib. each group contained ~30 patients, so I guess this is just a statistical fluke.

    Basically they took the results from a past clinical study, selected only patients who had a small decrease in ALSFR and then found that those patients survived longer. Is this really surprising? Does it show some efficacy in this drug? Does it really support the idea that the drug should be administered early to patients?

    There is a recent opinion piece in BMJ (after many similar opinions in Nature’s Journal) that we should consider the result of each clinical trial as fake until it is replicated by independent investigators.

  • jean-pierre-le-rouzic

    Member
    July 21, 2021 at 5:45 am

    There is no reason that this drug is not moved up and approved now by the FDA for ALS?

    I do not understand how data is impressive?

    If you look at the figure 2 in the scientific publication you will see that there is a 3% difference between placebo group and groups that received Masitinib. each group contained ~30 patients, so I guess this is just a statistical fluke.

    Basically they took the results from a past clinical study, selected only patients who had a small decrease in ALSFR and then found that those patients survived longer. Is this really surprising? Does it really support the idea that the drug should be administered early to patients?

  • Deleted User

    Deleted User
    July 22, 2021 at 9:01 am

    Eyes wide open.

     

    “Despite observing no long-term survival advantage for the overall masitinib 4.5 mg/kg/day cohort (LT-M4.5) of study AB10015 over placebo, investigators found an increasing improvement in median overall survival (OS) for masitinib in an enriched patient selected group. Statistical significance was reached for the LT-M4.5 cohort for those with at least 2 or greater on each baseline ALS Functional Rating Scale-revised (ALSFRS-R) item, with a median OS for masitinib (n = 50) of 69 months (95% CI, 44-non-estimate versus 44 months (95% CI, 31-62) for placebo (n = 63).”

    https://www.neurologylive.com/view/masitinib-shows-significant-prolonged-survival-als-phase-3?utm_source=sfmc&utm_medium=email&utm_campaign=7-21-21_NRLV_ClinicalFocusSpotlight_Unsponsored&eKey=am9obm55NUBqb2JiZXJvbmxpbmUubmV0

     

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