13Feb
FDA’s Oncologic Drugs Advisory Committee (ODAC) Votes to not Support Benefit/Risk Profile of Dacogen (decitabine) in Acute Myeloid Leukemia
In CategoryDrugs and Drug Companies
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Astex Pharmaceuticals, Inc. (NASDAQ:ASTX) today announced that the U.S. Food and Drug Administration’s (FDA’s) Oncologic Drugs Advisory Committee (ODAC) voted 10 to 3 with one person abstaining that data in our partner Eisai’s supplemental new Drug Application (sNDA) for DACOGEN® (decitabine) for Injection did not support a favorable benefit-risk profile for the treatment of acute myeloid leukemia (AML) in adults 65 years of age or older who are not considered candidates for induction therapy.
Tags: Acute Myeloid Leukemia, Dacogen, decitabine, FDA, oncologic drugs advisory committee
