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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P06-148
September 27, 2006

Media Inquiries:
Megan Moynahan, 301-827-6242
Consumer Inquiries:
888-INFO-FDA


 

FDA Approves a New Drug for Colorectal Cancer, Vectibix

The Food and Drug Administration (FDA) today approved Vectibix (panitumumab) for the treatment of patients with colorectal cancer that has metastasized (spread to other parts of the body) following standard chemotherapy. Vectibix, a monoclonal antibody that binds to a protein called epidermal growth factor receptor or EGFR on some cancer cells, received an accelerated approval after showing effectiveness in slowing tumor growth and, in some cases, reducing the size of the tumor.

In the United States, it is estimated that 150,000 new cases of colon cancer will be diagnosed and 55,000 deaths will occur from colon and rectal cancer in 2006. Approximately 70 percent of all colorectal carcinomas test positive for EGFR.

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

FDA approved Vectibix on the basis of the results of a randomized, controlled clinical trial of 463 patients with metastatic cancer of the colon and the rectum after undergoing treatment with chemotherapy drugs, fluoropyrimidine, oxaliplatin and 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 percent of the patients on Vectibix experienced a tumor shrinkage that in some cases exceeded 50 percent of the pre-treatment size of the tumor. Both study groups showed similar overall survival.

Under the accelerated approval program, drugs for serious and life-threatening diseases can be made available earlier in the development process if a promising effect of the drug is observed. As part of the approval, the manufacturer of Vectibix committed to conduct a postmarketing trial to show whether the drug improves patients’ survival in patients with fewer prior chemotherapies.

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.

Vectibix is manufactured by Amgen Inc. in Thousand Oaks, California.
 

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