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FDA Approves Vectibix (panitumumab) for Advanced Colorectal Cancer


ROCKVILLE, Md. -- The FDA has approved Vectibix (panitumumab), a monoclonal antibody that targets the epidermal growth factor receptor (EGFR), for treatment of metastatic colorectal cancer.

ROCKVILLE, Md., Sept. 28 -- The FDA has approved Vectibix (panitumumab), a monoclonal antibody that targets the epidermal growth factor receptor (EGFR), for treatment of metastatic colorectal cancer.

The FDA granted Vectibix accelerated approval after a clinical trial of 463 patients demonstrated that the drug added about a month to average survival or disease progression time compared with patients who received standard care.

The drug's maker, Amgen, said it would price the drug at ,000 per biweekly infusion, which is about 20% less than the price of Erbitux (cetuximab), a similar drug made by Imclone. Nonetheless, a year's treatment would cost about ,000, although few patients survive that long.

Patients in the pivotal trial had colorectal cancer that had metastasized after chemotherapy with 5-FU (fluoropyrimidine), Eloxatin (oxaliplatin), and Camptosar (irinotecan).

The mean time to disease progression or death in patients receiving Vectibix was 96 days versus 60 days in patients receiving the best standard supportive care. In addition, 8% of the patients on Vectibix experienced a tumor shrinkage that in some cases exceeded 50% of the pre-treatment size of the tumor. Both study groups showed similar overall survival.

The most serious adverse events in the studies of Vectibix included pulmonary fibrosis, severe skin rash complicated by infections, infusion reactions, abdominal pain, nausea, vomiting and constipation. The most common adverse events associated with the drug included skin rash, fatigue, abdominal pain, nausea, and diarrhea.

According to the FDA announcement about 70% of all colorectal carcinomas test positive for EGFR, which suggests that the Vectibix could be an important treatment option for many patients with advanced colorectal cancer, said Steven Galson, M.D., M.P.H., director of the FDA's Center for Drug Evaluation and Research.

As part of the accelerated approval program, Amgen has agreed to conduct a postmarketing trial to show whether the drug improves patients' survival in patients with fewer prior chemotherapies.

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