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FDA approves Vectibix to treat patients with metastatic colorectal cancer

THOUSAND OAKS, Calif., (Sept. 27, 2006) Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved VectibixTM (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 percent 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 signaling. 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 targ
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Contact: Christine Regan
805-447-5476
Porter Novelli
27-Sep-2006


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