Omapro omacetaxine mepesuccinate regulatory update

ChemGenex will delay a separate NDA submission for Omapro omacetaxine in third-line chronic myelogenous leukemia (CML) to 2H11 from year end 2010 to collect additional information from clinical trial sites required for the application. ChemGenex said FDA reiterated that no additional clinical trials would be required and that the application could be submitted based on the 2 ongoing pivotal Phase II trials, Study 202 and Study 203. The proposed indication covers CML patients who have failed prior treatment with >=2 tyrosine kinase inhibitors, regardless of their mutation status.

In April, FDA issued a complete response letter for an NDA for Omapro to treat Gleevec-resistant CML in patients who have the BCR-ABL T315I mutation. FDA did not request a new trial of Omapro and reiterated similar issues to those raised during a March FDA panel meeting. The 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). ...