• 3/30/2006
  • New York, NY
  • press release
  • TradingMarkets.com

Amgen Inc. said Thursday that it has completed the Biologic License Application submission with the U.S. Food and Drug Administration for experimental drug panitumumab as a treatment for metastatic colorectal cancer in patients who have failed prior chemotherapy, including oxaliplatin and/or irinotecan containing regimens.

Amgen, the world’s largest biotechnology company, is developing the drug Abgenix Inc. , another biotechnology company it is in the process of buying for about $2.2 billion in cash.

Amgen and Abgenix previously announced data from a randomized Phase 3 trial involving 463 patients that showed a 46% reduction in tumor progression rate in patients who received panitumumab every two weeks compared to those who received best supportive care alone.

Full results of the trial will be presented at the 97th Annual Meeting of the American Association for Cancer Research on April 3.

Willard Dere, chief medical officer and senior vice president of Global Development at Amgen, said, “Completing the BLA brings us one step closer to realizing our goal of making panitumumab accessible to patients with metastatic colorectal cancer who have failed available treatment options.”

Panitumumab is a fully human monoclonal antibody that targets the epidermal growth factor receptor, 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 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.