Cetuximab Approved by FDA for Patients With Late-Stage Head and Neck Cancer

Cetuximab (Erbitux), a chimeric monoclonal antibody and epidermal growth factor receptor (EGFR) inhibitor that is marketed in the United States by Bristol-Myers Squibb, was approved on Monday by the FDA for treating patients with late-stage head and neck cancer in combination with chemotherapy.

A multicenter clinical trial conducted outside of the United States enrolled 442 patients with metastatic or recurrent head and neck cancer. In the study, patients had inoperable or widespread disease and had not received prior chemotherapy. The study found that, on average, patients in the cetuximab arm of the study who received cisplatin or carboplatin and 5-fluorouracil with cetuximab lived 10.1 months, compared to 7.4 months in the group that received only chemotherapy. The FDA approved the drug despite the fact that the formulation of cetuximab used in the study was not the same as the approved formulation used in the United States.

“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 multitreatment approach for patients,” said Richard Pazdur, MD, director of the FDA’s Office of Hematology Oncology Products, in a statement released today. “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 side effects of cetuximab included rash; itching; nail changes; headache; diarrhea; and respiratory, skin, and mouth infections. Cetuximab has been associated with serious and potentially life-threatening infusion reactions and heart attack.

This is the first approval of cetuximab for use in patients with late-stage head and neck cancer. In 2004, the FDA approved cetuximab to treat EGFR-positive late-stage colon cancer after patients stopped responding to chemotherapy. In 2006, the drug was approved for the treatment of nonmetastatic head and neck cancer in combination with radiation therapy or as a single agent following standard treatment.

Despite cetuximab’s multiple indications for patients with head and neck cancer, data presented at the American Society of Clinical Oncology meeting in June showed that patients with locally advanced head and neck cancer gained no benefit in progression-free survival by taking cetuximab with chemoradiation compared with patients who took chemoradiation therapy alone.

According to the American Cancer Society’s Cancer Facts and Figures 2011, head and neck cancer accounts for about 3% to 5% of all cancers in the United States. This year, an estimated 52,140 people are expected to develop head and neck cancer, and an estimated 11,460 people will die from the disease.