The FDA approved the drug as part of an accelerated program that allows the approvals of treatments for cancer and other life-threatening diseases based on early evidence of a product’s effectiveness. In the case of Erbitux, the drug has not been shown to extend patients’ lives, but studies did provide evidence that it shrinks tumors in some patients.
“In their review activities, FDA staff work hard to ensure doctors and patients can have confidence in the safety and effectiveness of new therapies such as Erbitux,” said FDA Commissioner Dr. Mark McClellan.
“FDA believes it is crucial for cancer patients to have many proven treatment options in their battle against this disease,” he continued.
Erbitux is an antibody that interferes with cancer’s complex interplay of chemical growth signals. It was approved for use with the chemotherapy drug irinotecan, or alone if patients cannot tolerate irinotecan, the FDA said.
The FDA’s decision was based on a study conducted on 329 colon cancer patients who had clearly failed to respond to irinotecan. They were given either Erbitux alone or in combination with irinotecan.
The results released in June 2003 showed that 23 percent of patients getting the combination and 11 percent taking Erbitux alone responded to treatment, meaning their tumors shrank by at least half. However, the effect was typically brief. Median survival was nearly nine months for those on the combination and seven months for patients getting only Erbitux.
The FDA in 2001 had rejected Erbitux, citing the sloppiness of an earlier ImClone study on the drug. ImClone’s chief executive Samuel Waksal was arrested for telling family and friends, including Martha Stewart, about FDA’s decision before it was announced. Stewart is charged with lying to investigators about the ImClone sale.
Two studies involving some 2,000 patients are currently underway to asses Erbitux’s ability help colon cancer patients live longer.
The drug can cause serious side effects, including difficulty breathing and low blood pressure.
Colorectal cancer is the nation’s third most common cancer and the second-leading cancer killer. About 147,500 new cases were diagnosed last year, and it claimed 57,000 lives.
The American Cancer Society estimated some 106,370 new cases of colon cancer and 40,570 new cases of rectal cancer in 2003 in the United States. Combined, the group estimates the diseases caused about 56,730 deaths.