Can Tricky Elderly AML Population Justify Weak Data?
“The Pink Sheet” DAILY — Going into the Oncologic Drugs Advisory Committee’s Sept. 1 meeting, the outlook for Genzyme’s Clolar (clofarabine) and Vion’s Onrigin (laromustine) does not look good. FDA’s briefing documents suggest the evidence submitted is not sufficient for approval of either drug to treat elderly acute myeloid leukemia patients. But what remains to be seen is whether the panel thinks it is possible to obtain better, randomized and controlled data in the tricky disease setting.
