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FDA approves cetuximab for metastatic head and neck cancer
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The FDA has approved cetuximab for use with chemotherapy to treat patients with metastatic head and neck cancer. In 2006, the drug was approved as a single agent or to be used with first-line radiation to treat non-metastatic head and neck cancer.
Compared with chemotherapy alone, the combination of cetuximab (Erbitux; Bristol-Myers Squibb, Eli Lily) with chemotherapy improved survival.
"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," Richard Pazdur, MD, director of the Office of Hematology and Oncology Drug Products at the FDA's Center for Drug Evaluation and Research, said in a press release. "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 efficacy of cetuximab for this indication is based on the results of a multi-center clinical trial of 442 patients with metastatic or recurrent head and neck cancer. The study was conducted outside of the US and used a version of the drug that is not approved in the US, rather than the US-approved formulation.
Patients enrolled in the study had inoperable or widespread disease and had not received prior chemotherapy. Half were selected to receive cetuximab plus chemotherapy (cisplatin or carboplatin and 5-fluorouracil) or chemotherapy (cisplatin or carboplatin and 5-fluorouracil) only. Patients in the combination arm lived an average of 10.1 months, while those in the chemotherapy-only arm lived an average of 7.4 months.
The most common side effects reported in patients receiving cetuximab were rash, pruritus, nail changes, headache, diarrhea, and respiratory, skin and mouth infections. The drug can also cause low serum magnesium, potassium and calcium, and has been associated with serious and potentially life-threatening infusion reactions and heart attack. Patients taking cetuximab should limit their sun exposure.
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