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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“Using our drugs, we’re trying to facilitate the old drugs or help them work better longer,” Astex’s Lyons said. Astex, AstraZeneca and Novartis all presented data on compounds from Astex’s fragment-based drug discovery platform at the recent American Association for Cancer Research meeting in Washington, D.C.
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.
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.