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

This article was originally published in PharmAsia News

Executive Summary

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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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

No Additional Omapro Trials Needed, U.S. FDA Tells Australian ChemGenex In Complete Response Letter

PERTH, Australia - Australian-headquartered ChemGenex received a complete response letter from U.S. FDA for its new drug application for Omapro (omacetaxine mepesuccinate) for chronic myeloid leukemia, and the company is breathing a sigh of relief that it will not have to conduct additional trials or enroll additional patients, ChemGenex said April 12

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