FDA Panel: Separate Test Approval Needed Before Omapro Approval

A Food and Drug Administration panel said Monday that the agency needs to review a test to determine if patients with chronic myeloid leukemia have a particular type of mutation before taking action on proposed cancer drug Omapro.

The drug, also known by its generic name omacetaxine, is being developed by ChemGenex Pharmaceuticals Ltd. (CXSPY, CXS.AU) to treat a subgroup of patients with CML.

Specifically, the company is seeking approval for Omapro to treat patients with a mutation known as T315I that can develop in some patients after being treated with Gleevec. Gleevec, by Novartis AG (NVS, NOVN.VX) is currently the mainstay of treatment for chronic myeloid leukemia, or CML.

However, the agency said there is no commercially available method to test patients to see if they have the T315I mutation. The agency said 35% of patients in the study didn't have their mutation status confirmed when they entered the study, and that the response of patients in the study to the drug was considered "low."

The FDA asked the panel for advice on whether a diagnostic test that can determine if a patient has a T3151 mutation should be required and reviewed by the FDA before it considers whether to approve Omapro. The panel voted 7 to 1 in favor of the question. The panel didn't vote on whether it thinks the FDA should approve the product.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; [e-mail]