Dacogen Leukemia Indication Needs New Clinical Trial, FDA Tells Eisai
This article was originally published in Pharmaceutical Approvals Monthly
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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FDA complete response letter requests another randomized study of the acute myeloid leukemia drug to show it is safe and increases survival in elderly patients.