FDA Approves Amgen Colon Cancer Drug Vectibix
Colon Cancer Treatment Drug
The U.S. Food and Drug Administration said on Wednesday it had approved Amgen Inc's drug Vectibix for the treatment of advanced colon cancer.
Vectibix, known chemically as panitumumab, was approved for use in patients whose colon cancer has spread after chemotherapy has failed.
The drug, which is expected to compete with Erbitux from ImClone Systems Inc. has been considered one of the most important experimental medicines in Amgen's drug pipeline. Analysts have projected that eventual peak sales for the drug would exceed $1 billion a year.
Vectibix, a monoclonal antibody that binds to a protein called epidermal growth factor receptor 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, the FDA said in a statement.
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.
"This approval adds a treatment option for patients with an advanced stage of a disease that can be life-threatening," said Dr. Steven Galson, director of FDA's Center for Drug Evaluation and Research.
A pivotal-stage trial showed that patients treated with Vectibix showed a better-than-expected 46 percent decrease in the rate of tumor growth versus those who received supportive care.
As part of the approval, Amgen committed to conduct a post marketing trial to show whether the drug improves patients' survival in patients with fewer prior chemotherapies, the FDA said.
Amgen, the world's largest biotechnology company, gained full rights to the drug through its acquisition of Abgenix.