Astex Pharmaceuticals, Inc. has announced that the FDA's Oncologic Drugs Advisory Committee (ODAC) voted 10 to 3 with one person abstaining that data in their partner Eisai's supplemental new Drug Application (sNDA) for DACOGEN(R) (decitabine) for Injection did not support a favorable benefit-risk profile for the treatment of acute myeloid leukemia (AML) in adults 65 years of age or older who are not considered candidates for induction therapy.
The FDA has the option of seeking the advice of its advisory committees when it is reviewing a new drug application, although it is not obliged to follow the committee's recommendation. The PDUFA date is March 6, 2012.
The advisory committee reviewed data from Eisai's supplemental New Drug Application (sNDA) which was accepted for FDA review in July 2011. The application is based on the open-label Phase III clinical trial (DACO-016) data presented at the 2011 Annual Meeting of the American Society of Clinical Oncology (ASCO).