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news.The FDA has approved ImClone Systems and Bristol-Myers Squibb's Erbitux, an IgG1 monoclonal antibody, for use in the treatment of squamous cell carcinoma of the head and neck.
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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 specifically 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 – one of the largest studies ever conducted in head and neck cancer patients – 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.
“This is an important milestone as Erbitux is the first FDA approved therapy for head and neck cancer patients in more than 30 years,” said Dr Kie-Kian Ang, a radiation oncology professor at The University of Texas M D Anderson Cancer Center.