sNDA Accepted for Dacogen for Acute Myeloid Leukemia
Eisai Inc. announced that the FDA has accepted its supplemental New Drug Application (sNDA) of Dacogen (decitabine) for injection in the treatment of acute myeloid leukemia (AML). The sNDA is based on the Phase 3, randomized, open-label, multicenter trial (DACO-016) comparing Dacogen vs. patient's choice with physician's advice of either supportive care or low-dose cytarabine in patients ≥65 years with newly diagnosed de novo or secondary AML and with poor- or intermediate-risk cytogenetics.
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) 274-2378 or visit http://us.eisai.com.