No New Trials, Omapro "Complete Response" Says, But Diagnostic Is Desired
This article was originally published in Pharmaceutical Approvals Monthly
Australian-headquartered ChemGenex received a "complete response" letter from 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, the company said April 12
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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.
ChemGenex must determine which chronic myeloid leukemia patients have the T351I mutation and could benefit from the drug.
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