Astex dinged by US FDA verdict on failed Dacogen study
This article was originally published in Scrip
US FDA drug reviewers on 7 February wasted no time in pointing out the major problem with Eisai's supplemental new drug application (sNDA) for Dacogen (decitabine), a nucleoside metabolic inhibitor, as a treatment for acute myelogenous leukemia (AML) in adults 65 years or older who are not considered candidates for induction chemotherapy: the firm's study failed to demonstrate a statistically significant improvement in the primary endpoint of overall survival.
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