MONDAY, Nov. 7 (HealthDay News) -- U.S. Food and Drug Administration approval of Erbitux (cetuximab) has been expanded to include late-stage (metastatic) head and neck cancer, the agency announced Monday.
The drug was first approved in 2004 to treat colon cancer, and was later sanctioned to treat non-metastatic cases of head and neck cancer.
Clinical testing for the newly approved use involved 442 people with metastatic or recurring head and neck cancer. People who received Erbitux and chemotherapy lived an average of 10.1 months, compared with 7.4 months among those who received chemotherapy alone.
Head and neck cancer accounts for up to 5 percent of all cancer cases in the United States, and is most common in men and in people older than age 50, the FDA said, citing statistics from the U.S. National Cancer Institute.
The most common side effects reported for Erbitux include rash, itching, nail changes, headache, diarrhea, and respiratory, skin and mouth infections. People who take Erbitux should limit exposure to the sun, the FDA warned.
The drug is marketed by Bristol-Myers Squibb, based in New York City, and Indianapolis-based Eli Lilly & Co.
The National Cancer Institute has more about head and neck cancer.
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