The U.S. Food and Drug Administration today approved cetuximab Erbitux (Bristol-Myers Squibb)for use with chemotherapy to treat patients with late-stage (metastatic) head and neck cancer.

Combined with chemotherapy, cetuximab extended the lives of those receiving the treatment combination compared with those receiving chemotherapy alone. Cetuximab already is FDA-approved for certain types of colon cancer, and has been approved since 2006 for treatment of non-metastatic head and neck cancer in combination with radiation therapy (first-line) or as a single agent (following standard treatment).

According to the National Cancer Institute, head and neck cancers account for 3% to 5% of all cancers in the United States. These cancers typically develop in the nose, throat or mouth and they are more common in men and in people older than 50.

Extending lives
“Erbitux’s ability to extend the lives of patients with head and neck cancers is an important tool for oncologists who often rely on a multi-treatment approach for patients,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research.” Given the aggressive nature of head and neck cancers that cannot be treated with surgery and radiation, it is important that patients have as many treatment options available as possible.”

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The safety and effectiveness of cetuximab for this indication is based on the results of a multi-center clinical study conducted outside the United States involving 442 patients with metastatic or recurrent head and neck cancer. The study used a non-U.S. approved version of cetuximab, rather than the U.S.-approved formulation.

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Participants had inoperable or widespread disease and had not received prior chemotherapy. Half 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. Cetuximab also caused low serum magnesium, potassium, and calcium and has been associated with serious and potentially life-threatening infusion reactions and heart attack. Patients taking cetuximab were encouraged to limit their exposure to the sun.

Cetuximab 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.

For more information:
– FDA: Office of Hematology and Oncology Drug Products
– FDA: Approved Drugs: Questions and Answers
– NCI: Head and Neck Cancer

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