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Australian ChemGenex's Omapro Faces Scaled Back Efficacy Claims After Trial Shortcomings

This article was originally published in PharmAsia News

Executive Summary

After a snow delay in Washington, Australian-headquartered ChemGenex now has more time to prepare for what will likely be a challenging review of Omapro (omacetaxine mepesuccinate) by U.S. FDA's Oncologic Drugs Advisory Committee

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Australia's ChemGenex Reaches Agreement With U.S. FDA To Re-file Omapro NDA For Third-Line CML Treatment

PERTH, Australia - The chief executive officer of Melbourne-headquartered ChemGenex told investors and analysts July 14 that the company has reached agreement with U.S. FDA for a regulatory pathway forward of its Omapro (omacetaxine) new drug application for third-line treatment of chronic myeloid leukemia for patients who have failed multiple tyrosine kinase inhibitors

Australia's ChemGenex Reaches Agreement With U.S. FDA To Re-file Omapro NDA For Third-Line CML Treatment

PERTH, Australia - The chief executive officer of Melbourne-headquartered ChemGenex told investors and analysts July 14 that the company has reached agreement with U.S. FDA for a regulatory pathway forward of its Omapro (omacetaxine) new drug application for third-line treatment of chronic myeloid leukemia for patients who have failed multiple tyrosine kinase inhibitors

Australian ChemGenex Readies Omapro For Second NDA Despite U.S. FDA Setbacks

PERTH, Australia - Australian-headquartered ChemGenex has completed pivotal trials for Omapro for third-line treatment for chronic myeloid leukemia for patients who have failed multiple tyrosine kinase inhibitors; the company expects to file its application with U.S. FDA while its NDA for second-line treatment for CML in patients with the Brc-Abl T315I is still under review

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