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FDA Approves Vectibix for Colorectal Cancer

New drug fast-tracked after researchers find it slows tumor growth

THURSDAY, Sept. 28 (HealthDay News) -- The U.S. Food and Drug Administration has approved a new drug called Vectibix (panitumumab) for use in colorectal cancer patients with metastasis after chemotherapy. Vectibix, a monoclonal antibody made by Amgen, Inc., was given rapid-track approval after a study showed it slowed tumor growth and extended time to relapse or death.

The most common side effect of the drug is rash, but the serious side effects include pulmonary fibrosis, skin rash complicated by infections, infusion reactions, abdominal pain, nausea, vomiting and constipation.

Vectibix binds to an epidermal growth factor receptor, which is found in 70 percent of all colorectal cancers. A study of 463 colorectal cancer patients with metastasis found the mean time to cancer progression or death was 96 days in patients on Vectibix, versus 60 days for patients given conventional treatment.

Although the survival outcome was similar for both sets of patients, tumors shrank in 8 percent of Vectibix patients, sometimes by 50 percent or more.

"Colorectal cancer is the third-most common cancer and the third-leading cause of cancer mortality in the United States," Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research, said in a statement. "This approval adds a treatment option for patients with an advanced stage of a disease than can be life threatening."

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