Erbitux (Cetuximab) Approved For Metastatic Head And Neck Cancer, USA

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Main Category: Ear, Nose and Throat
Also Included In: Cancer / Oncology;  Regulatory Affairs / Drug Approvals
Article Date: 08 Nov 2011 - 0:00 PST


Erbitux (cetuximab) has been approved by the US FDA for combination use with chemotherapy for late-stage head and neck cancer treatment. When given together with chemotherapy, Erbitus was found to extend the lives of patients compared to those on chemotherapy alone.

Cetuximab, is already approved by the FDA for some kinds of colon cancer, as well as non-metastatic head and neck cancer along with first-line radiation therapy, or on its own after standard treatment.

The National Cancer Institute says between 3% to 5% of all cancers in the USA are head and neck cancers. They usually start off in the mouth, throat or nose and are more common among males over the age of 50 years.

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."

The FDA based its decision on a multi-center clinical study involving 442 participants that was carried out outside the USA. A non-US approved version of the drug was used in the study. All the patients had recurrent or metastatic head and neck cancer.

All the patients had widespread or inoperable cancer and had never received chemotherapy before. They were divided into two groups:

• Cetuximab with chemotherapy group - chemotherapy consisted of cisplatin or carboplatin and 5-fluorouracil
  Patients survived for an average of 10.1 months
• The chemotherapy only group - chemotherapy consisted of cisplatin or carboplatin and 5-fluorouracil
  Patients survived for an average of 7.4 months

The most common adverse events (side effects) among the cetuximab patients was pruritus (itching), headache, nail changes, rash, diarrhea, and skin, mouth and respiratory infections. Cetuximab can also cause low calcium, potassium and serum magnesium. The medication has been linked to serious and potentially fatal infusion reactions and heart attack. Patients receiving cetuximab should not be exposed to sunlight for too long.

Erbitux was approved by the FDA in 2004 for EGFR (epidermal growth factor receptor) positive late-stage colon cancer after chemotherapy stopped working.

Cetuximab's molecular formula is C₆₄₈₄H₁₀₀₄₂N₁₇₃₂O₂₀₂₃S₃₆. It is a chimeric (mouse/human) monoclonal antibody; it is an EGFR (epidermal growth factor receptor), administered by intravenous infusion.

Erbitux is marketed by Bristol-Myers Squibb and Eli Lilly and Company.

Written by Christian Nordqvist


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