The priority review designation means that the FDA will try to complete its review of the drug within six months, rather than the usual nine. The designation was granted to the drug because the FDA believes it has potential to provide a significant therapeutic advance for patients.
The rolling biologic license application submission for panitumumab was initiated in December 2005 and completed in March 2006.
In April 2006, marketing applications were submitted to the European Medicines Agency (EMEA) and Health Canada and in May 2006 in Australia and Switzerland.
Panitumumab is an investigational fully human monoclonal antibody that targets the epidermal growth factor receptor (EGFr), a protein that plays an important role in cancer cell signaling. The drug is being evaluated in clinical trials as both a monotherapy and in combination with other agents for the treatment of various types of cancer, including colorectal, lung and head and neck.