Erbitux Approved for Metastatic Head and Neck Cancers

Today, Erbitux (cetuximab) earned FDA approval to treat patients with late-stage head and neck cancers in combination with platinum-based chemotherapy. The approval is based on a phase 3, multi-center study conducted outside the U.S. that found Erbitux in combination with chemo improved overall survival compared with those on chemo alone. Half of the 442 patients with recurrent or metastatic squamous cell carcinoma of the head and neck were randomly assigned to receive Erbitux in combination with chemotherapy, and the other half received chemotherapy alone. The average overall survival was 10.1 months in the Erbitux group whereas it was only 7.4 months in the chemo-alone group. You can read the full study results at The New England Journal of Medicine.Erbitux is a monoclonal antibody that blocks epidermal growth factor receptors on the surface of head and neck cancer cells, and thus, slows their growth. It is already approved to treat EGFR-positive, late-stage colon cancer and as a first-line therapy with radiation and as a single agent after standard therapy for non-metastatic squamous cell carcinoma of the head and neck.The most common side effects are rash, itching, nail changes, headache, diarrhea and infections. Erbitux is also associated with more serious side effects, such as infusion reactions and heart attacks. Patients on Erbitux are also advised to limit sun exposure.For details, visit erbitux.com or call 888-372-4889. For patient assistance and reimbursement help, call 800-861-0048.