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news.Astex Pharmaceuticals partner Eisai has received a Complete Response Letter from the US Food and Drug Administration (FDA) for its 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.
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The application was not approved by FDA 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 (p=0.11).
Janssen-Cilag International submitted a separate Marketing Authorization Application to the European Medicines Agency (EMA) in May 2011 for Dacogen in the treatment of patients with AML.
The EMA is expected to issue a decision on this application later this year.
Dacogen is currently approved for the treatment of MDS in about 30 countries, and is licensed to Eisai, while Astex receives royalties on global sales of the drug.