Australia's ChemGenex Reaches Agreement With U.S. FDA To Re-file Omapro NDA For Third-Line CML Treatment
This article was originally published in PharmAsia News
Executive Summary
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