US FDA panel rejects Eisai, Astex AML drug
This article was originally published in Scrip
Executive Summary
Although Eisai's and Astex Pharmaceuticals' nucleoside metabolic inhibitor Dacogen (decitabine) failed to demonstrate a statistically significant improvement in overall survival in older adults with acute myelogenous leukaemia (AML) in a Phase III study, the drug had three vocal cheerleaders on its side among advisers to the US FDA on 9 February.