The U.S. Food and Drug Administration has approved Erbitux (cetuximab) for use with chemotherapy to treat patients with late-stage (metastatic) head and neck cancer. The drug, has been used to treat non-metastatic head and neck cancer in combination with radiation therapy (first-line) or as a single agent (following standard treatment), as well as in the treatment of certain types of colon cancer since 2006.
According to the National Cancer Institute, head and neck cancers account for 3%-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.
“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.”
The safety and effectiveness of Erbitux 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.
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. 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.
Those wishing to learn more about treatments for the above mentioned cancers can contact the Smilow Cancer Center at Yale, 333 Cedar St., New Haven, CT 06520 203 785-4141.