Amgen announced that the US Food and Drug Administration (FDA) has approved Vectibix (panitumumab) following priority review.

Vectibix is the first entirely human monoclonal antibody for the treatment of patients with epidermal growth factor receptor- (EGFr) expressing metastatic colorectal cancer after disease progression on, or following fluoropyrimidine-, oxaliplatin-, and irinotecan- containing chemotherapy regimens.

The FDA approval of Vectibix was based on a progression-free survival endpoint. Vectibix is the first anti-EGFr antibody shown to significantly improve progression-free survival in patients with metastatic colorectal cancer. Currently no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vectibix. Vectibix can be conveniently administered intravenously once every two weeks.

Vectibix is expected to be commercially available in early-to-mid October and will be priced at approximately 20 per cent less than the other anti-EGFr antibody currently on the market.

"Vectibix is the first entirely human antibody for the treatment of colorectal cancer to be approved by the FDA. It provides another option for patients with metastatic colorectal cancer that have progressed on all available chemotherapy regimens," said J. Randolph Hecht, M.D., director of the UCLA Gastrointestinal Oncology Program and clinical professor of Medicine, UCLA David Geffen School of Medicine, Los Angeles. "In a large, randomized clinical trial, Vectibix has been shown to delay progression of disease compared to best supportive care."

Epidermal growth factor receptors are proteins that play an important role in cancer cell signalling. Vectibix is an entirely human IgG2 monoclonal antibody that binds with high affinity to EGF receptors. The goal of developing entirely human monoclonal antibodies is to offer effective targeted therapies with lessened risk of immune response against these agents.

"Our goal is to fulfil the promise of biotechnology to improve the way cancer is treated," said Willard Dere, M.D., chief medical officer and senior vice president of Global Development at Amgen. "The approval of Vectibix allows us to build on our strong foundation in supportive care and move forward with our comprehensive approach to helping patients in their fight against cancer."

"One out of 18 people in this country will develop colorectal cancer in their lifetime and 20 per cent of colorectal cancers are found after the disease has spread to distant organs." said Amy Kelly, director and co-founder of the Colon Cancer Alliance. "That means that a person in the U.S. is diagnosed with colorectal cancer every four minutes, heightening the need for new therapeutic options such as Vectibix."

Marketing applications were simultaneously submitted to the European Medicines Agency (EMEA) in April 2006 and Health Canada, Australia and Switzerland in May 2006. Vectibix is being evaluated in ongoing clinical trials as both a monotherapy and in combination with other agents for the treatment of various types of cancer.