Dacogen misses AML endpoint

Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) said Dacogen decitabine missed the primary endpoint of significantly improving overall survival vs. low-dose cytarabine or supportive care in a Phase III trial to treat acute myelogenous leukemia (AML) in elderly patients. Eisai said it plans to submit an sNDA to FDA for the hypomethylating agent to treat elderly patients with AML and poor-or intermediate-risk cytogenetics by March 31, 2011 based on the primary analysis, in which "a trend was evident," and supporting secondary data from additional endpoints. The open-label trial enrolled 485 patients. ...