The Food and Drug Administration (FDA) last week approved the targeted drug cetuximab (Erbitux), in combination with chemotherapy, for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck.

The approval was based on the results of an international phase III clinical trial of 442 patients with metastatic or recurrent squamous cell cancer of the head and neck who had not previously received chemotherapy. Patients treated with cetuximab and chemotherapy (5-FU in combination with either cisplatin or carboplatin) had improved overall survival compared with patients who received chemotherapy alone (10.1 months versus 7.4 months). Patients who received cetuximab had a higher incidence of several side effects, including diarrhea, respiratory and other infections, and serious infusion reactions.

Cetuximab, which targets the epidermal growth factor receptor, is already approved for patients with nonmetastatic head and neck cancer and for some patients with advanced colorectal cancer.

source:FDA