Reviewers: AML study shows no benefit with Dacogen

FDA reviewers said a Phase III study intended to support the approval of Dacogen decitabine in elderly patients with acute myelogenous leukemia failed to demonstrate a benefit. The comments came in briefing documents released ahead of Thursday's meeting of the Oncologic Drugs Advisory Committee to discuss an sNDA from Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) for the product. The Phase III trial in 485 patients showed that Dacogen led to a 2.7 month improvement in median overall survival (OS), the primary endpoint, over low-dose cytarabine or supportive care, but the difference was not statistically significant (7.7 vs. 5 months, p=0.11). ...