The Food and Drug Administration approved
colorectal cancer drug Vectibix, a product that analysts say could yield big sales for the company and put serious pressure on Erbitux, the colon cancer treatment from
Amgen's drug, whose generic name is panitumumab, was approved by the FDA on Wednesday for patients whose colorectal cancer had spread to other parts of the body after chemotherapy.
"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 the 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."
The FDA estimates that this year 150,000 new cases of colon cancer will be diagnosed and 55,000 deaths will occur. About 70% of all colorectal cancers test positive for a protein, EFGR, which is found in some cancer cells. The Amgen drug binds to EFGR and can slow a tumor's growth or, in some instances, reduce the size of the tumor, the FDA says.
The FDA approved the drug based on tests with 463 patients, some of whom received Vectibix plus chemotherapy and others who received standard care plus chemotherapy. It took an average of 96 days for Vectibix patients to experience a progression in their disease vs. 60 days for the other patients.
"Eight percent of the patients on Vectibix experienced a tumor shrinkage that in some cases exceeded 50 percent of the pretreatment size of the tumor," the FDA says. Both study groups showed similar overall survival.
News of the FDA's approval came just as the markets were closing. Amgen's stock, aided by a sharp spike in the last minutes of trading, gained $1.39, or 2%, to close at $72.14. ImClone's stock, which had a big dip at the end of the day, closed at $28.75, losing 69 cents, or 2.3%.