The Biologic License Application (BLA) for panitumumab, Amgen's investigational human monoclonal antibody targeting the epidermal growth factor receptor (EGFr), has been granted priority review by the US FDA. The application covers the use of panitumumab for the treatment of metastatic colorectal cancer in patients who have failed prior chemotherapy.
Given the priority status, the FDA will announce its decision within six months from application (BLA submission was completed in March 2006). Marketing applications have likewise already been submitted in April 2006 to the European Medicines Agency (EMEA) and Health Canada, and in May 2006 in Australia and Switzerland.
Source: Amgen press release
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