Erbitux is designed for use in combination with radiation therapy to treat patients with squamous cell cancer of the head and neck (SCCHN) that cannot be removed by surgery.
It's the first drug approved for head and neck cancer that has shown a survival benefit in this population, according the FDA.
The FDA also approved Erbitux to be used without other drugs (monotherapy) in treating patients whose head and neck cancer has spread despite the use of standard chemotherapy.
Head and Neck Cancers
Head and neck cancers are more common in men and in people over age 50.
Tobacco, including chewing tobacco, and alcohol are factors that increase the risk of these cancers. Head and neck cancers affect the mouth, nose, sinuses, and throat.
Because of the location of these cancers, people affected often have significant problems with swallowing and speaking.
First New Drug Approved in Decades
Erbitux, which received a priority review from the FDA, is the first drug approved by the FDA to treat head and neck cancer since methotrexate became available in the 1950s.
Approval of Erbitux in combination with radiation therapy was based on a study showing that Erbitux prolonged survival by more than a year and a half, compared with treatment with radiation alone.
Approval of Erbitux monotherapy was based on evidence of tumor shrinkage in 13% of patients, lasting on average of six months.
Every year, about 29,000 new cases of head and neck cancer are diagnosed in the U.S., according to the FDA.
The FDA's Comments
"We consider this approval an important advance in the treatment of head and neck cancer because it has been shown to help some patients live longer," says Steven Galson, MD, MPH, in an FDA news release. Galson directs the FDA's Center for Drug Evaluation and Research.
"The approval of Erbitux monotherapy to shrink tumors in patients with metastatic disease who no longer respond to other forms of treatment is also important. Patients need as many effective treatment options as possible," he adds.
Unlike many chemotherapy drugs that work by poisoning cancer cells, Erbitux is an antibody. Erbitux blocks the effect of a major growth factor that is responsible for causing cancers to grow.
Erbitux is also used in other cancers, such as colorectal cancer.
Two studies established Erbitux's safety and effectiveness.
One study included 424 patients with head and neck cancer. Using Erbitux in combination with radiation therapy showed a survival time of four years vs. nearly 2.5 years on radiation therapy alone. Tumors also grew slower in the group that got Erbitux and radiation.
In head and neck cancer, tumor growth is associated with pain and difficulties with swallowing, speaking, and eating. Controlling tumor growth for as long as possible is important for patients' well-being.
The second study included 103 patients with recurrent or metastatic SCCHN. Erbitux helped to shrink the patients' tumors after the tumors no longer responded to platinum-based therapy, the standard treatment for patients with this difficult-to-treat disease.
Commonly reported side effects of Erbitux were infusion reactions (fever, chills), skin rash, fatigue/malaise, and nausea, states the FDA.
Radiation's common side effects — such as sore mouth, trouble swallowing, and radiation-related skin changes — were similar in frequency in patients receiving Erbitux plus radiation and those receiving radiation alone.
Erbitux is manufactured by ImClone Systems Inc. and will be distributed and marketed by Bristol-Myers Squibb Co.
SOURCES: News release, FDA. News release, ImClone. National Cancer Institute: Head and Neck Cancer.
By Miranda Hitti
Ann Edmundson, MD
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