FDA Accepts DACOGEN® (Decitabine) SNDA Submission In Acute Myeloid Leukemia
SuperGen, Inc. (NASDAQ:SUPG), a pharmaceutical company dedicated to the discovery and development of novel cancer therapies, announced that Eisai Inc. today released information that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) seeking approval of DACOGEN ® (decitabine) for injection in the treatment of acute myeloid leukemia. Acute myeloid leukemia (AML) is a life-threatening cancer of the blood for which there are few treatment options.
Acceptance of the sNDA indicates that the FDA has found Eisai’s submission to be sufficiently complete to review. The sNDA was submitted to FDA on May 6, 2011.
The application is based on the Phase III randomized open-label, multi-center trial (DACO-016) comparing DACOGEN versus patient’s choice with physician’s advice of either supportive care or low-dose cytarabine in patients 65 years and older with newly diagnosed de novo or secondary AML and with poor- or intermediate-risk cytogenetics. It is the largest randomized controlled study in older patients with AML conducted to date.
About DACOGENDACOGEN 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. Important Safety Information Treatment with DACOGEN is associated with neutropenia and thrombocytopenia. Complete blood and platelet counts should be performed as needed to monitor response and toxicity but at a minimum prior to each dosing cycle. After administration of the recommended dosage for the first cycle, treatment for subsequent cycles should be adjusted if indicated by dose adjustment guidelines. Clinicians should consider the need for early institution of growth factors and/or antimicrobial agents for the prevention or treatment of infections in patients with MDS.
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