FDA accepts Eisai's DACOGEN sNDA for review to treat acute myeloid leukemia

Jul 13 2011

Eisai Inc. today announced 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 the company's submission to be sufficiently complete to review. The sNDA was submitted to the 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 acute myeloid leukemia (AML) and with poor- or intermediate-risk cytogenetics. It is the largest randomized controlled study in older patients with AML conducted to date.

Source: Eisai Co., Ltd.