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