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FDA will let ChemGenex file Omapro in third-line CML with no mutation test required

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA has agreed to let Australian biopharma ChemGenex seek approval for its oncology drug Omapro (omacetaxine) as a third-line therapy in chronic myeloid leukemia without a requirement for genetic testing. The agency issued a "complete response" in April on a second-line application, asking for a companion diagnostic test to select for patients with the Bcr-Abl T3151 mutation (1"The Pink Sheet" DAILY, April 12, 2010). Patients in the third-line setting are identified by their resistance to therapies rather than individual mutation status, CEO Greg Collier told analysts during a July 14 call. Based on discussions with the agency, the company will submit pooled data from two pivotal studies showing efficacy in patients who have failed prior treatment with two or more currently approved tyrosine kinase inhibitors. ChemGenex expects to file the NDA by the end of the year, while it continues to work with the agency to gain approval of the test that can move the second-line application forward. The third-line indication means a much larger patient population and commercial opportunity in the U.S., where there are no approved therapies in that setting, Collier said (2PharmAsia News, July 14, 2010). A European marketing application in the second-line setting is on track, with a potential approval in the first quarter of 2011

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