ChemGenex Pharmaceuticals Limited announced the completion of its New Drug Application (NDA) submission to the US Food & Drug Administration (FDA) for Omapro (omacetaxine mepesuccinate). Omapro is being developed for the treatment of patients with chronic myeloid leukaemia (CML) who have failed treatment with imatinib and who have developed the Bcr-Abl T315I mutation. Imatinib, a tyrosine kinase inhibitor (TKI), is the first-line standard of care for patients with CML. Omapro is a first-in-class cetaxine which works differently from imatinib, and the second-line TKIs nilotinib and dasatinib.
Omapro has received Orphan Drug designation in the US and in the European Union, and has received fast track status from the FDA. Omapro demonstrated clinical benefit in the pivotal Study 202, in CML patients who had failed imatinib and have the T315I mutation. Interim data were recently presented at the American Society of Clinical Oncology Annual Meeting.
"If approved, Omapro would be the first treatment specifically indicated for CML T315I patients, many of whom have no therapeutic options," said Adam R Craig senior vice president and chief medical officer. "We thank the investigators, their research staff and patients for participating in the pivotal study."
If the FDA grants priority review for Omapro the examination period is expected to be approximately six months. If approved for marketing by the FDA following priority review, the launch of Omapro would be scheduled for mid-2010.
Greg Collier, ChemGenex's chief executive officer and managing director, said, "The submission of the NDA for Omapro is a major milestone in the development of this novel product and we are now one step closer to delivering a new treatment for patients in an area of unmet medical need. This submission is a significant achievement in our strategic goal to commercialize Omapro independently in the US oncology market."
Omacetaxine is administered subcutaneously and acts differently from TKIs. It may have a therapeutic advantage for patients who have failed TKIs.
ChemGenex is an oncology focused biopharmaceutical company developing small molecules with new mechanisms of action to treat malignancies with significant unmet medical needs.