Mar 1 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 is a significant milestone in the review process for
OMAPRO. Our team is well-prepared and we are looking forward to
presenting to the ODAC panel”
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 well-prepared and we are looking forward to
presenting to the ODAC panel,” said Greg Collier, PhD, CEO and Managing
Director of ChemGenex.
Source:
ChemGenex Pharmaceuticals Limited
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