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Abgenix drug gets fast-track OK from FDA
Posted on 2005-08-03 06:18:00
Abgenix Inc. and its partner Amgen Inc. said the FDA granted them fast-track status for their treatment of colon cancer in patients who have not responded to chemotherapy. Putting the drug panitumumab on the FDA's fast track list means the regulator will accept parts of the companies' marketing application on a rolling basis as those sections are completed. The status was created to speed introduction of drugs to treat life-threatening conditions for which there are unmet medical needs.
Fremont-based Abgenix and Amgen of Thousand Oaks are working to submit their application to market the drug by the end of 2005, the companies said August 1.
FDA has indicated that data from one pivotal trial, once completed, could be acceptable with additional data from other pending studies to support a submission for marketing approval in the U.S. Panitumumab was co-developed by Amgen and Abgenix. It is being evaluated as both a therapy on its own and in combination with other agents to treat various types of cancer, including colorectal, lung and kidney.
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