FDA Issues Complete Response Letter to sNDA for Dacogen

Eisai Inc. announced that it received a complete response letter from the FDA for its supplemental New Drug Application (sNDA) for Dacogen (decitabine) for the treatment of acute myeloid leukemia (AML) in adults ≥65 years of age who are not considered candidates for induction therapy.

The FDA declined to approve the application because it said that the primary study (DACO-016) did not provide convincing evidence of safety and effectiveness for the proposed AML indication.

Dacogen is currently approved for treatment of patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS of all French-American-British (FAB) subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia), and Intermediate-1, Intermediate-2 and High-Risk International Prognostic Scoring System (IPSS) groups. 

For more information call (888) 422-4743 or visit www.eisai.com/US.