ODAC votes down AML drug as FDA raises concerns over equipoise, uncertain efficacy

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The FDA Oncologic Drugs Advisory Committee May 14 voted 8-3 against approval of quizartinib for the treatment of adults with relapsed or refractory acute myeloid leukemia which is FLT3- ITD positive, as detected by an FDA-approved test.

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Paul Goldberg
Editor & Publisher

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