Briefing documents released ahead of Tuesday afternoon's meeting of the FDA's Oncologic Drugs Advisory Committee scheduled to review quizartinib tablets signaled a potential uphill battle for Daiichi Sankyo Co. Ltd., of Tokyo, which filed the NDA last year seeking approval for treating adults with relapsed or refractory acute myeloid leukemia (AML) that is FLT3-ITD positive, as detected by an FDA-approved test.