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U.S. Food and Drug Administration (FDA) Sets 22 March for Oncologic Drugs Advisory Committee (ODAC) Meeting to Review OMAPROâ?¢ MELBOURNE, Australia, and MENLO PARK, California USA (2 March 2010)
02 / 03 / 2010
ChemGenex Pharmaceuticals Limited (ASX:CXS) announced today that the U.S. Food and Drug Administration (FDA) has rescheduled the previously postponed Oncologic Drugs Advisory Committee (ODAC) meeting to 22 March 2010.The ODAC meeting will consider ChemGenex’s application for OMAPRO™ (omacetaxine mepesuccinate) 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. As an independent panel of experts the role of the ODAC committee is to review safety and efficacy data and make recommendations to the FDA concerning approval.
"The ODAC meeting is a significant milestone in the review process for OMAPRO, our team is wellprepared and we are looking forward to presenting to the ODAC panel” said Greg Collier, PhD, CEO and Managing Director of ChemGenex.