Eisai Will Make “Totality Of The Evidence” Argument At FDA Panel Review Of Dacogen

Briefing documents for the Oncologic Drugs Advisory Committee’s Feb. 9 meeting suggest Eisai will argue that the totality of the data on decitabine’s efficacy and safety in elderly patients with acute myelogenous leukemia is sufficient to overcome the pivotal trial’s failure to show a statistically significant overall survival benefit in the primary analysis. In contrast, FDA’s review takes a laser-like focus on the failed primary endpoint.