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    • #19967
      john s
      Participant

      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!

      • This topic was modified 1 week, 3 days ago by john s. Reason: sp
      • This topic was modified 1 week, 3 days ago by Kevin Schaefer.
    • #19971

      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.

    • #19974

      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?

    • #19995
      john s
      Participant

      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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