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GEN News Highlights : Sep 28, 2006

FDA Approves Vectibix to Treat Patients with Metastatic Colorectal Cancer

Clearance of this first fully human antibody was based on increased progression-free survival.
Amgen received approval for its metastatic colorectal cancer drug, Vectibix™ (panitumumab). “Vectibix is the first entirely human antibody for the treatment of colorectal cancer to be approved by the FDA,” points out J. Randolph Hecht, M.D., lead investigator of the Vectibix study.

“It provides another option for patients with metastatic colorectal cancer that have progressed on all available chemotherapy regimens. In a large, randomized clinical trial, Vectibix has been shown to delay progression of disease compared to best supportive care.”

Vectibix is targeted at patients with epidermal growth factor receptor- (EGFr) expressing metastatic colorectal cancer after disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy. It is an entirely human IgG2 Mab that binds with high affinity to EGF receptors. However, no data is available that shows an improvement in symptoms or increase in survival.

Vectibix is expected to be commercially available in early- to mid-October and will be priced at approximately 20% less than the other anti-EGFr antibody on the market. Marketing applications were submitted to the EMEA in April 2006 and Health Canada, Australia, and Switzerland in May 2006.

Vectibix can be administered intravenously once every two weeks. The drug is also being evaluated as a monotherapy, as well as in combination with other agents for the treatment of various types of cancer.