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

DUBLIN, Calif.--(BUSINESS WIRE)--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.