ChemGenex's Omapro on track for FDA approval

Cancer specialists ChemGenex today announced that its recent Type A Meeting with the FDA has resulted in discussions outlining a regulatory path for the approval of its Omapro (omacetaxine mepesuccinate) treatment for patients with Chronic Myeloid Leukemia (CML).

The announceent saw the company’s shares surge over 33 percent today.

Company CEO Greg Collier told an investment briefing this morning that the FDA has invited ChemGenex to combine the data from its key Study 202 and Study 203 studies and submit a New Drug Application (NDA) for the use of Omapro to treat patients with CML for whom treatment with two or more approved tyrosine kinase inhibitors (TKIs) has been unsuccessful, and regardless of their mutation status.

These patients currently have no approved therapies available to them.

“We are pleased with the outcome of this Type A meeting as it provides another option for advancing the development timeline for Omapro,” Collier said.

“By pursuing this new indication for multi TKI-resistant patients, OMAPRO can potentially treat a significantly larger patient population in the United States, and we plan to submit our new NDA to the FDA by the end of the year.”

ChemGenex said that discussions are ongoing with the FDA’s Center for Devices and Radiological Health regarding approval of a diagnostic test for the T315I mutation, confirming that the existing NDA for T315I positive CML patients who have not found success with Novartis’ imatinib. Initially the FDA had stipulated that Omapro would not be approved before approval of the T315I test, however this condition no longer applies under the new arrangements.

ChemGenex is still awaiting European approval for the use of Omapro for these patients, which it said it was on track to receive in the first quarter of next year.