FDA Approves ERBITUX for Treatment of Head and Neck Cancer

The U.S. Food and Drug Administration has approved ERBITUX (cetuximab), an IgG1 monoclonal antibody, for the treatment of squamous cell carcinoma of the head and neck. Developed by ImClone Systems Incorporated and Bristol-Myers Squibb Company, ERBITUX is the first and only monoclonal antibody to be approved for this indication. It is indicated for use in combination with radiation therapy for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck, and as a single agent in recurrent or metastatic SCCHN where prior platinum-based chemotherapy has failed.

Key Takeaways:

• ERBITUX is the first FDA-approved therapy for head and neck cancer patients in over 30 years.
• The approval is based on a Phase III study that demonstrated a survival and locoregional control advantage when ERBITUX was added to radiation therapy.
• A Phase II study showed that ERBITUX therapy alone reduced tumor size.
• ERBITUX has been shown to improve median duration of locoregional control by 9.5 months and median survival by 19.7 months compared to radiation therapy alone.
• The total number of patients in the Phase III study was 424, with 211 patients receiving ERBITUX and radiation therapy, and 213 patients receiving radiation therapy alone.
• The median number of ERBITUX doses administered in the clinical study was eight, with a range of 1-11 infusions.
• A single-arm, multicenter, Phase II trial studying the effects of ERBITUX as a single-agent treatment showed a clinically meaningful objective response rate of 13% (95% Confidence Interval 7%-21%).
• Patients demonstrated a median duration of response of 5.8 months (range 1.2-5.8 months).