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ODAC votes against Dacogen in AML

February 10, 2012 1:19 AM UTC

FDA's Oncologic Drugs Advisory Committee voted 10-3, with one abstention, that Dacogen decitabine did not demonstrate a favorable benefit-risk profile to treat newly diagnosed acute myelogenous leukemia (AML) in patients 65 years and older. The vote follows briefing documents released Tuesday that said the Phase III trial intended to support Dacogen's approval in the indication failed to demonstrate a benefit. The trial in 485 patients showed that Dacogen led to a 2.7 month improvement in median overall survival (OS) over low-dose cytarabine or supportive care, but the difference was not statistically significant (7.7 vs. 5 months, p=0.11). The sNDA, submitted by Eisai Co. Ltd. (Tokyo:4523; Osaka:4523), has a March 6 PDUFA date (see BioCentury Extra, Feb. 7). ...