Erbitux Approval Expanded to Include Head and Neck
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
The drug was first approved in 2004 to treat colon cancer, and
was later sanctioned to treat non-metastatic cases of head and neck
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
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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