ChemGenex Pharmaceuticals Limited announced that the US Food & Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for Omapro (omacetaxine mepesuccinate) 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. The NDA has also been granted Priority Review. A Priority Review designation is given to drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists, and generally denotes that the FDA review period is reduced to approximately six months. ChemGenex submitted the NDA on 8 September 2009.
“We are pleased that the FDA has accepted our NDA for Omapro and granted the filing Priority Review status which underscores the critical need for a treatment option for the CML T315I+ patient population,” said Greg Collier, ChemGenex’s chief executive officer and managing director. “We look forward to working closely with the agency over the next several months as they review our filing. If approved, we plan to launch Omapro in the US as the first therapy specifically indicated for CML T315I patients.”
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.
Omacetaxine mepesuccinate 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.