ChemGenex Pharmaceuticals Limited has completed a pre-NDA meeting with the US Food and Drug Administration (FDA) concerning the potential regulatory path to progress Omapro (omacetaxine mepesuccinate) for the treatment of patients with Chronic Myeloid Leukaemia (CML) who have failed two or more tyrosine kinase inhibitors (TKIs).

At the meeting the FDA agreed that the proposed New Drug Application (NDA) for Omapro for CML patients who have failed prior treatment with two or more currently approved tyrosine kinase inhibitors (TKIs) could be submitted based on combined data from ChemGenex’s two pivotal studies, Study 202 and Study 203.

It was agreed that no further clinical trials are required to complete this NDA submission, however further data will need to be collected from participating clinical centres. ChemGenex believes that based on the timing required for collection of this additional data, the NDA for Omapro for the treatment of CML patients who have failed two or more TKIs regardless of their mutation status, will be submitted in H2 2011.

Greg Collier, managing director and chief executive officer of ChemGenex said, “We appreciate the guidance that the FDA has given the company as it prepares this new NDA, and look forward to working with the FDA to seek approval for the use of OMAPRO to potentially treat a significantly larger patient population in the United States.”

ChemGenex is an oncology focused biopharmaceutical company developing small molecules with new mechanisms of action to treat malignancies with significant unmet medical needs.