FDA issues complete response letter regarding the NDA for OMAPRO

Apr 12 2010

ChemGenex Pharmaceuticals announces that the U.S. Food and Drug Administration's (FDA) Office of Oncology Drug Products has issued a complete response letter regarding the new drug application (NDA) for OMAPRO™ (omacetaxine mepesuccinate) for the treatment of adults with chronic myeloid leukemia (CML) who have failed prior therapy with imatinib and have the Bcr-Abl T315I mutation.

The complete response letter does not contain a request for a new study, nor is there a request for enrollment of additional patients into the pivotal study on OMAPRO.

Commenting on the correspondence from the FDA, Greg Collier, PhD, CEO for ChemGenex said, "The complete response letter from the FDA provides the initial guidance towards our endeavor to bring a new therapy to CML patients who harbour the T315I mutation and currently have very limited or unsatisfactory treatment options. Because the principal issues raised by the FDA were similar to those discussed during the 22 March meeting of the Oncology Drug Advisory Committee (ODAC), and based upon our interpretation of the scientific requirements underpinning the complete response letter, we are confident that we can work in a positive manner with the FDA to address the outstanding matters. We appreciate the constructive comments made by the agency in the response letter and ChemGenex will seek a meeting with the FDA to discuss and find agreeable solutions for each of the FDA's requests."

Minutes from the 22 March ODAC meeting can be accessed from the FDA's website (http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM207638.pdf).

ChemGenex also met on April 9^th with the US FDA's Center for Devices and Radiological Health (CDRH) to discuss a path forward for the development of a well defined diagnostic test for the T315I mutation. Both parties agreed to work together toward the validation of the T315I assay that meets the FDA's requirements.