Eisai Inc. announced today preliminary results from a randomized Phase III clinical trial of Dacogen® (decitabine) for Injection versus either a low-dose chemotherapy agent or supportive care in elderly patients with acute myeloid leukemia (AML), a life-threatening cancer of the blood that generally occurs in older adults.
The primary endpoint of this study was overall survival. Although Dacogen did not reach statistically significant superiority over the control arm, a trend was evident.
Based on the primary analysis and supporting secondary data from additional endpoints, Eisai is planning to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Dacogen in the treatment of elderly patients with AML and poor- or intermediate-risk cytogenetics. The submission of an application is planned by March 31, 2011.
Eisai is further examining the data to better understand the full implications of the study. Eisai will seek to share the comprehensive results of the data with the medical community at future major medical meetings and in peer-reviewed publications.
The most frequently reported adverse events include neutropenia, anemia, thrombocytopenia, fever and pneumonia. Sepsis and febrile neutropenia were reported as serious adverse events.
Eisai is committed to identifying potential treatment options for diseases such as AML in keeping with its human health care (hhc) mission of striving to address unmet medical needs for patients and their families.
Acute myeloid leukemia (AML) is an aggressive, fast-growing cancer that starts inside the bone marrow with production of abnormal blood cells. It is generally a disease of older adults, with an average patient age of 67, and is slightly more common among men than women. The most common symptoms of AML include weight loss, tiredness, fever, night sweats, and loss of appetite. AML can sometimes spread to other parts of the body including the lymph nodes, liver and spleen. In 2008, there were slightly more than 13,000 new cases of AML reported and nearly 9,000 deaths in the United States.
Dacogen (decitabine) for Injection is indicated 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.
Recently, a five-day dosing regimen for Dacogen was approved by the FDA for the treatment of MDS. Dacogen was first approved by the FDA as a three-day dosing regimen for the treatment of patients with MDS on May 2, 2006.
Dacogen is currently approved for the treatment of MDS in more than 20 countries outside of the United States, where it is being developed and marketed by Janssen-Cilag International NV and other affiliates of Cilag GmbH International, the licensing partner of Eisai.