Amgen has completed the BLA submission to the FDA for panitumumab for the treatment of metastatic colorectal cancer in patients who have failed prior chemotherapy, including oxaliplatin and/or irinotecan containing regimens. The rolling BLA submission was initiated in December 2005.

Amgen and Abgenix’s data from a randomized Phase III trial of 463 patients showed that those who received the drug every two weeks showed a 46% decrease in tumor progression rate versus those who received best supportive care alone. The most common side effect was acneiform rash. Other side effects less commonly observed were fatigue, nausea and mild diarrhea.

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 received Fast Track designation from the FDA in July 2005 for patients with metastatic colorectal cancer who have failed standard chemotherapy treatment. It is being evaluated 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.