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

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.