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

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

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The agency declined to approve decitabine for use in elderly patients with acute myelogenous leukemia because the pivotal study failed to demonstrate a statistically significant survival benefit in the pre-specified primary analysis. FDA’s “complete response” letter tracks with a negative evaluation by the Oncologic Drugs Advisory Committee in February.

Dacogen Leukemia Indication Needs New Clinical Trial, FDA Tells Eisai

The agency declined to approve decitabine for use in elderly patients with acute myelogenous leukemia, pointing to the failure of the pivotal trial to show a survival benefit on primary analysis. FDA’s “complete response” letter tracks with a negative evaluation by the Oncologic Drugs Advisory Committee in February.

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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