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Dacogen Leukemia Indication Needs New Clinical Trial, FDA Tells Eisai

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

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.

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