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Dacogen Leukemia Indication Would Require New Clinical Trial, FDA Tells Eisai

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

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