Astex Pharmaceuticals Inc. (ASTX) said that Janssen-Cilag International NV was notified that the European Commission has approved the marketing authorization for DACOGEN for the treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukemia or AML, according to the World Health Organization classification, who are not candidates for standard induction chemotherapy. Also, DACOGEN has been granted Orphan Drug designation to treat AML.
The data in support of the marketing authorization is based on the Phase 3 DACO-016 study that compared decitabine to patients' choice with physician advice of either supportive care or low-dose cytarabine in the treatment of older patients with AML.
DACO-016 was a Phase 3, randomized, open-label trial, in newly diagnosed patients =65 years of age with de novo or secondary AML and poor- or intermediate-risk cytogenetics.
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