Erbitux Extends Survival in Patients with Metastatic Head and Neck Cancer, FDA Approves

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Many drugs approved for one kind of disease are tested in clinical trials on other forms of illness and are found to be effective. Such is the case with Erbitux (cetuximab). Already approved for colon cancer, the Bristol-Myers Squibb/Eli Lilly medication is now approved for metastatic head and neck cancer treatment. Erbitux is also continuing in clinical trials for the treatment of lung cancer.

Erbitux is an anti-epidermal growth factor receptor (EGFR) monoclonal antibody which works by binding to EGFR, thereby preventing its activation. This inhibits tumor growth and metastasis. The drug was first approved in the US in 2004 for EGFR-positive late-state colon cancer in patients who no longer responded to chemotherapy. In 2006, its indications were expanded for use in combination with radiation for the treatment of locally or regionally advanced (non-metastatic) squamous cell carcinoma of the head and neck.

The FDA approval is based on a multi-center clinical study known as EXTREME (Erbitux in First-Line Treatment of Recurrent or Metastatic Head and Neck Cancer) involving 442 volunteers with metastatic head and neck cancer who had not received chemotherapy. Patients were divided into two groups. The first received cetuximab with cisplatin or carboplatin and 5-fluorouracil chemotherapy. The second group only received the chemotherapy treatment.

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Those patients on both the experimental drug and chemotherapy lived longer than those on chemo alone – 10.1 months versus 7.4 months. Also notable was the length of progression-free survival and response rate. The most common adverse events were itching, headache, diarrhea, and skin, mouth and respiratory infections. Erbitux may also cause low electrolyte levels, particularly potassium, calcium and magnesium.

Richard Pazdur, M.D., director of the Office of Hematology and Oncology Drug Products in the FDA's Center for Drug Evaluation and Research, said: "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. 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."

Head and neck cancers include those of the oral cavity (lips, tongue, gums, etc), salivary glands, paranasal sinuses and nasal cavity, pharyns, and larynx (voice box). The National Cancer Institute says between 3 to 5% of all cancers in the US are of the head and neck, and they are more common in men and people over the age of 50. Eighty-five percent of head and neck cancers are linked to tobacco use.

For more on Erbitux (cetuximab), please read:
FDA Approves ERBITUX As A Single Agent In Patients With Advanced Colorectal Cancer
Rash During Erbitux Treatment for Lung Cancer May Be Good Sign

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