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Totality Of Data Weigh Against Leukemia Indication For Eisai’s Dacogen, FDA Panel says

This article was originally published in The Pink Sheet Daily

Executive Summary

Oncologic Drugs Advisory Committee votes 10-3, with one abstention, that a favorable risk-benefit profile has not been demonstrated for decitabine’s use in elderly patients with acute myelogenous leukemia. In addition to the pivotal trial’s failure to show a significant survival benefit, committee members raise concerns about adequacy of the comparator treatment used in the study, geographic variations in the efficacy results and problems selecting appropriate patients for treatment.


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