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
ByRuss Bianchi

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.

FDA’s Oncologic Drugs Advisory Committee (ODAC) Votes to not Support Benefit/Risk Profile of Dacogen (decitabine) in Acute Myeloid Leukemia

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