At FDA's Sept. 10 Oncologic Drugs Advisory Committee meeting, Adria Senior Director-Medical Research Richard Gams, MD, indicated that the survival curve in the Southeastern Center Study Group (SEG) was "certainly unfavorable to patients treated with idarubicin" in the intensive maintenance arm, a distinction that was not made clear in "The Pink Sheet" (Sept. 17, p. 6). In the treatment arm, the median survival was better for idarubicin than daunorubicin. Idamycin was approved Sept. 27 in acute myeloid leukemia. Approved labeling for the drug notes that "intensive maintenance with Idamycin is not recommended".
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