Astex Pharmaceuticals, Inc. (NASDAQ: ASTX) today announced that the U.S. Food and Drug Administration has issued a Complete Response Letter to partner Eisai for their supplemental New Drug Application (sNDA) for Dacogen® (decitabine) for Injection for patients with acute myeloid leukemia (AML) in adults 65 years of age or older who are not considered candidates for induction therapy.
The FDA declined to approve the application because the pre-specified analysis of the primary endpoint in the study (DACO-016) did not demonstrate statistically significant superiority of Dacogen over the control arm.
A separate Marketing Authorization Application was submitted to the European Medicines Agency (EMA) in May 2011 by Janssen for Dacogen in the treatment of patients with AML. It is expected the EMA will issue a decision on this application later this year.
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