ChemGenex Pharmaceuticals Limited (ASX:CXS) announced today the U.S. Food and Drug Administration (FDA) has notified the company that the Oncologic Drugs Advisory Committee (ODAC) will conduct a public advisory meeting on 10 February 2010 to review the Company’s NDA for Omapro™ (omacetaxine mepesuccinate) for injection. The proposed indication for Omapro is for the treatment of adults with chronic myeloid leukemia (CML) who have failed prior therapy with imatinib and who have developed the Bcr-Abl T315I mutation. The Advisory Committee provides advice and recommendations to the FDA on regulatory issues.
ChemGenex submitted the NDA on 9 September 2009. The NDA was accepted by the FDA on 10 November 2009 and granted Priority Review.