ODAC Looks Beyond Dacogen Study’s Statistical Failure, But Still Finds Little Support For New Use
In evaluating a new leukemia indication for Eisai’s Dacogen, the Oncologic Drugs Advisory Committee and FDA reviewers showed they are willing to look beyond a missed efficacy endpoint, but only if the supportive evidence of benefit is really solid. Ten of 14 committee members ultimately concluded that decitabine did not have a favorable risk-benefit profile for elderly AML patients.
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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.
AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.
Office of New Drugs Director Peter Stein tells the Pink Sheet that last phase of massive reorg was complicated by pandemic restrictions that forced review staff to work remotely, but the structural overhaul resulted in smaller, more nimble review groups and the breaking down of silos that ultimately helped the agency’s response to the public health crisis.