MELBOURNE, Australia & MENLO PARK, Calif.--(BUSINESS WIRE)--ChemGenex Pharmaceuticals Limited (ASX:CXS) announced today the completion of its New Drug Application (NDA) submission to the U.S. Food & Drug Administration (FDA) for OMAPRO™ (omacetaxine mepesuccinate). OMAPRO™ is being developed for the treatment of patients with chronic myeloid leukemia (CML) who have failed treatment with imatinib and who have developed the Bcr-Abl T315I mutation. Imatinib, a tyrosine kinase inhibitor (TKI), is the first-line standard of care for patients with CML. OMAPRO™ is a first-in-class cetaxine which works differently from imatinib, and the second-line TKIs nilotinib and dasatinib.
