Dacogen decitabine regulatory update

FDA's Oncologic Drugs Advisory Committee voted 10-3, with 1 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 Feb. 7 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, has a March 6 PDUFA date. ...