Omapro omacetaxine mepesuccinate regulatory update

ChemGenex plans to submit a separate NDA by year end for Omapro omacetaxine in third-line chronic myelogenous leukemia (CML) after meeting with FDA to discuss an April complete response letter for an NDA for second-line use. The new proposed indication covers CML patients who have failed prior treatment with two or more tyrosine kinase inhibitors (TKIs), regardless of their mutation status. The existing NDA, which the company said will remain open, covers Gleevec-resistant CML in patients who have the BCR-ABL T315I mutation.

ChemGenex said it is continuing discussions with FDA's Center for Devices and Radiological Health (CDRH) regarding a diagnostic test for the T315I mutation. In March, an FDA panel recommended that a well-characterized in vitro diagnostic to identify patients with the T315I mutation be required and reviewed by FDA (see BioCentury, March 29). ...