Amgen’s Panitumumab Gets Priority Review

Amgen’s BLA for panitumumab, an investigational fully human monoclonal antibody that targets the epidermal growth factor receptor (EGFr), has been granted Priority Review by the FDA. The BLA was submitted for the treatment of metastatic colorectal cancer patients who have failed prior chemotherapy, including oxaliplatin and/or irinotecan containing regimens. A Priority Review designation means that the FDA will target an Agency action within six months of the application’s submission date.

Priority Review status is assigned by the FDA to those applications the Agency has deemed to have the potential to provide a significant therapeutic advance for patients. The rolling BLA submission for panitumumab was initiated in December 2005 and completed in March 2006. Panitumumab received Fast Track designation from the FDA in July 2005. In April 2006, marketing applications were submitted to the EMEA and Health Canada and in May 2006 in Australia and Switzerland.