Amgen/Abgenix submit cancer MAb BLA to FDA

US biotechnology groups Amgen and Abgenix have completed their Biologic License Application submission to the Food and Drug Administration for their drug candidate panitumumab for the treatment of metastatic colorectal cancer in patients who have failed chemotherapy, including oxaliplatin and/or irinotecan-containing regimens.

Amgen and Abgenix previously announced that data from a randomized, 463-patient Phase III trial showed that those who received panitumumab every two weeks achieved a 46% decrease in tumor progression rate versus those who were given best supportive care alone (p<0.000000001). Results from this pivotal study were presented at the 97th annual meeting of the American Association for Cancer Research, in Washington DC.

The agent, which is a fully-human monoclonal antibody targeting the epidermal growth factor receptor, received Fast Track designation from the FDA in July 2005 for patients with metastatic colorectal cancer who failed standard chemotherapy. The firms noted that it is being evaluated both as a monotherapy and in combination with other agents for the treatment of various types of cancer, including colorectal, lung and head and neck.