FDA Approves Erbitux for Head and Neck Cancer

ImClone Systems and Bristol-Myers Squibb received approval from the FDA for Erbitux for use in the treatment of squamous cell carcinoma of the head and neck. Designed to inhibit the function of the epidermal growth factor receptor (EGFR)—a molecular structure linked to tumor growth—Erbitux is the first and only monoclonal antibody to be approved for the treatment of head and neck cancer.

With this approval, Erbitux is now indicated for use in combination with radiation therapy for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN) and as a single agent in recurrent or metastatic SCCHN where prior platinum-based chemotherapy has failed. These indications are based on a Phase III study that demonstrated a survival and locoregional control advantage when Erbitux was added to radiation therapy, and a Phase II study, where Erbitux therapy alone reduced tumor size.