FDA Grants Priority Review of Amgen's Panitumumab for Treatment of Patients with Metastatic Colorectal Cancer
Amgen announced that the U.S. food and Drug Administration (FDA) has accepted the 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.
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 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. Panitumumab, an IgG2 monoclonal antibody, binds with high affinity to the EGFr. Panitumumab was generated with XenoMouse(R) technology, which creates a fully human monoclonal antibody that contains no murine (mouse) protein. The body's immune system can recognize the mouse protein found in chimeric and humanized antibodies as foreign and may launch an immune response. The goal of developing fully human monoclonal antibodies is to offer effective targeted therapies with minimum risk of immune response against these agents.
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Topic world Antibodies
Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous
Topic world Antibodies
Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous