FDA Approves Erbitux® For Treatment of Head and Neck Cancer

FDA Approves Erbitux® For Treatment of Head and Neck Cancer

FDA Approves Erbitux® For Treatment of Head and Neck Cancer

The United States Food and Drug Administration (FDA) has approved the monoclonal antibody Erbitux® (cetuximab) for the treatment of head and neck cancer. The indication is for the use of Erbitux in combination with radiation therapy for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck, or as a single agent in recurrent or metastatic squamous cell carcinoma of the head and neck that has progressed following prior platinum-based chemotherapy.

Approximately 40,000 people in the U.S. are diagnosed with head and neck cancer every year. Cancers of the head and neck comprise several types of cancer; these include the nasal cavity and sinuses, oral cavity, nasopharynx, oropharynx, and other sites throughout the head and neck area. Squamous cell carcinoma of the head and neck refers to the most common type of head and neck cancer.

Standard treatment for head and neck cancer is largely determined by the stage (extent to which the cancer has spread) and by the specific locations within the head or neck area where the cancer has spread. The patients overall medical condition is also a deciding factor. Treatment typically consists of radiation therapy, chemotherapy with surgery, or surgery alone.

Once head and neck cancer has spread from its site of origin, long-term outcomes are generally less favorable. In addition, treatment for head and neck cancer often results in a compromised quality of life. In order to improve long-term outcomes and quality of life for patients with this disease, research and development of novel therapeutic approaches continues.

The epidermal growth factor receptor (EGFR) pathway is a focus of this research. This biologic pathway plays a role in cellular replication and is often over-expressed in cancer. Erbitux, a monoclonal antibody (or protein), has been developed in a laboratory with the purpose of binding to the EGFR and inhibiting the receptors effects on cellular replication.

Erbitux was previously FDA-approved to be used in combination with Camptosar® (irinotecan) for the treatment of colorectal cancer that has stopped responding to irinotecan-based chemotherapy. The drug is also approved as a single agent in patients who are not able to tolerate treatment with irinotecan. Erbitux is currently being evaluated in clinical trials for the treatment of various types of cancers.

The clinical trial that prompted FDA approval of Erbitux for head and neck cancer included a multi-national clinical trial to evaluate the addition of Erbitux to radiation therapy in the treatment of locoregionally advanced (spread of cancer from site of origin but not to distant sites in the body) head and neck cancer. This trial included 424 patients; approximately half were treated with Erbitux plus high-dose radiation therapy, and the other half received high-dose radiation therapy alone.

  • With an average follow-up of 54 months, patients treated with the addition of Erbitux to radiation therapy had improved outcomes compared to those treated with radiation therapy alone.
  • The median duration of time that no cancer recurrences occurred in or near the site of original cancer was 24.4 months for patients treated with Erbitux/radiation therapy, compared to only 14.9 months for those treated with radiation therapy alone.
  • Median duration of overall survival was 49 months for those treated with Erbitux/radiation therapy, compared to only 29.3 months for those treated with radiation therapy alone.
  • Progression-free survival was also significantly improved for patients treated with Erbitux/radiation therapy.
  • Rash and reactions at the site of infusions were the most common side effects experienced by patients treated with Erbitux.

The researchers concluded that the addition of Erbitux to radiation therapy is well tolerated and improves overall survival compared to radiation therapy alone in the treatment of patients with head and neck cancer.

Patients diagnosed with head and neck cancer should speak with their physician regarding their individual risks and benefits of treatment with Erbitux.

Reference: ImClone Systems Incorporated. FDA Approves ERBITUX(R) (Cetuximab) for Treatment of Head and Neck Cancer; First and Only Approved Monoclonal Antibody for Squamous Cell Carcinoma of the Head and Neck. Available at: =. Accessed March 2006.

Related News:

Addition of Erbitux® to Radiation Therapy Improves Survival in Head and Neck Cancer (2/9/06)

Latest Data on Marked Survival Improvement with Erbitux® in Head and Neck Cancer (11/22/05)

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