Vectibix is a monoclonal antibody that binds to a protein called epidermal growth factor receptor or EGFR on some cancer cells.
The FDA said in a statement that the drug received an accelerated approval after showing effectiveness in slowing tumor growth and, in some cases, reducing the size of the tumor.
An estimated 150,000 new cases of colon cancer will be diagnosed and about 55,000 people will die from colon and rectal cancer in the United States this year.
Approximately 70 percent of all colorectal carcinomas test positive for EGFR.
Dr. Steven Galson, director of FDA's Center for Drug Evaluation and Research, said in a statement, "Colorectal cancer is the third most common cancer and the third leading cause of cancer mortality in the United States... This approval adds a treatment option for patients with an advanced stage of a disease that can be life-threatening."
The FDA approved Vectibix based on the results of a randomized, controlled clinical trial of 463 patients with metastatic cancer of the colon and the rectum. These patients had undergone 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 care.
In addition, 8 percent of patients on Vectibix experienced shrinkage of their tumors. In some cases, tumors were reduced by more than 50 percent. Both study groups showed similar overall survival.
The most serious adverse effects 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.
