Australia's ChemGenex Reaches Agreement With U.S. FDA To Re-file Omapro NDA For Third-Line CML Treatment
This article was originally published in PharmAsia News
Executive Summary
PERTH, Australia - The chief executive officer of Melbourne-headquartered ChemGenex told investors and analysts July 14 that the company has reached agreement with U.S. FDA for a regulatory pathway forward of its Omapro (omacetaxine) new drug application for third-line treatment of chronic myeloid leukemia for patients who have failed multiple tyrosine kinase inhibitors
You may also be interested in...
Cephalon, A Target Itself, To Acquire Remainder Of Australian ChemGenex
Cephalon Inc. announced March 29 that it has struck an agreement with the Australia-based biopharma ChemGenex Pharmaceuticals Ltd. to pay A$159 million ($US $163 million) for the piece of the company it doesn't already own
Cephalon, A Target Itself, To Acquire Remainder Of Australian ChemGenex
Cephalon Inc. announced March 29 that it has struck an agreement with the Australia-based biopharma ChemGenex Pharmaceuticals Ltd. to pay A$159 million ($US $163 million) for the piece of the company it doesn't already own
FDA will let ChemGenex file Omapro in third-line CML with no mutation test required
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