The US Food and Drug Administration has expanded the approval of Erbitux® (cetuximab) to include the initial treatment, in combination with platinum-based chemotherapy, of selected patients with recurrent or metastatic squamous cell head and neck cancer.

Head and neck cancers originate in the tissues in or around the mouth, nose, and throat. Risk factors for head and neck cancer include smoking, alcohol consumption, and infection with high-risk types of human papillomavirus (HPV). Patients with head and neck cancer that has spread to other parts of the body or that has returned after initial treatment have limited treatment options, and researchers continue to explore new and more effective approaches to treatment.

Erbitux is a targeted therapy that inhibits growth of the cancer by binding to a portion of the epidermal growth factor receptor (EGFR), a protein located on the surface of many cancer cells. Erbitux was previously approved for other uses in head and neck cancer and colorectal cancer.

A study known as EXTREME (ErbituX in first-line Treatment of REcurrent or MEtastatic head and neck cancer) contributed to the most recent approval of Erbitux. The study enrolled patients with metastatic or locally recurrent head and neck cancer who were not candidates for potentially curative treatment with surgery or radiation. Patients were treated with chemotherapy alone or in combination with Erbitux.

The combination of chemotherapy and Erbitux improved overall survival: Overall survival was 7.4 months among patients treated with chemotherapy alone and 10.1 months among patients treated with chemotherapy plus Erbitux. Erbitux also delayed cancer progression. The most common side effects in the Erbitux group included nausea, anemia, vomiting, low white-blood cell counts, rash, weakness, diarrhea, and loss of appetite.

In addition to its other uses, Erbitux is now approved in combination with platinum-based chemotherapy for the initial treatment of patients with recurrent and/or metastatic squamous cell cancer of the head and neck.

Reference: US Food and Drug Administration. Cetuximab (Erbitux). November 7, 2011.

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