FDA's ODAC voted to review T315I mutation prior to approval of OMAPRO

Mar 23 2010

ChemGenex Pharmaceuticals Limited (ASX:CXS) announced today that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 7-1 that a validated test to identify the T315I mutation should be reviewed by the FDA prior to approval of OMAPRO™ (omacetaxine mepesuccinate).

“We are encouraged by the positive comments from some members of the ODAC panel about the benefits of OMAPRO and the unmet medical need for CML patients with the T315I mutation”

ChemGenex has been working with the FDA on the T315I diagnostic matter and the FDA has confirmed that it will meet with ChemGenex to review the diagnostic strategy on 9 April 2010.

The question posed to the ODAC panel by the FDA was not regarding the safety and efficacy of OMAPRO, but was stated as the following:

“Should a well characterized in vitro diagnostic to identify patients with the T315I mutation be required and reviewed by the FDA and correlated to clinical trial results prior to approval of omacetaxine for the proposed indication?”

“We are encouraged by the positive comments from some members of the ODAC panel about the benefits of OMAPRO and the unmet medical need for CML patients with the T315I mutation,” said Adam R. Craig, M.D., Ph.D., Senior Vice President and Chief Medical Officer, ChemGenex. “We have a meeting scheduled next month with members of the FDA’s drug and diagnostic teams and will continue to work with the agency as it considers our new drug application for OMAPRO.”

“Over the past several months, ChemGenex has been working closely with the FDA on a diagnostic strategy to allow for approval of OMAPRO. We are committed to making OMAPRO available to patients as soon as possible,” added Greg Collier, Ph.D., Chief Executive Officer and Managing Director, ChemGenex.

ChemGenex is seeking FDA approval 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. T315I is a common mutation that renders CML resistant to all currently approved tyrosine kinase inhibitors (TKIs).