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FDA Approves Erbitux to Treat Late-stage Head and Neck Cancer
Date:11/7/2011

were selected to receive either the combination of cetuximab with chemotherapy (cisplatin or carboplatin and 5-fluorouracil) or chemotherapy (cisplatin or carboplatin and 5-fluorouracil) only. Patients receiving the cetuximab with chemotherapy combination lived, on average, 10.1 months compared with 7.4 months for those receiving chemotherapy only.

The most common side effects reported in patients receiving cetuximab were rash, itching (pruritus), nail changes, headache, diarrhea, and respiratory, skin, and mouth infections. Erbitux also can cause low serum magnesium, potassium, and calcium. Erbitux has been associated with serious and potentially life-threatening infusion reactions and heart attack. Patients taking Erbitux should limit their exposure to the sun.

Erbitux was first approved by the FDA in 2004 to treat Epidermal Growth Factor Receptor (EGFR)-positive late-stage colon cancer after patients stopped responding to chemotherapy. The treatment can be used alone or in combination with chemotherapy.  

Erbitux is marketed by New York City-based Bristol-Myers Squibb.

For more information:

FDA: Office of Hematology and Oncology Drug Products

http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm091745.htm

FDA: Approved Drugs: Questions and Answers

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm

NCI: Head and Neck Cancer

http://www.cancer.gov/cancertopics/types/head-and-neck

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is
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SOURCE U.S. Food and Drug Administration
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