FDA gives Priority Review to Amgen's panitumumab for colorectal cancer
The US Food and Drug Administration (FDA) has accepted the Amgen's Biologic License Application (BLA) for panitumumab, an investigational fully human monoclonal antibody that targets the epidermal growth factor receptor (EGFr) and has granted Priority Review.
The US Food and Drug Administration (FDA) has accepted the Amgen's Biologic License Application (BLA) for panitumumab, an investigational fully human monoclonal antibody that targets the epidermal growth factor receptor (EGFr) and has granted Priority Review.
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.
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 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. It 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.