U.S. FDA Says Australian ChemGenex Needs Companion Diagnostic For Omapro
This article was originally published in PharmAsia News
Executive Summary
Australian-headquartered ChemGenex has agreed to meet with U.S. FDA in April to begin developing a validated assay test for determining which patients might benefit from its experimental chronic myeloid leukemia treatment Omapro.
You may also be interested in...
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