Cetuximab Gains New Indication for Metastatic Head/Neck Cancer

December 2011, Vol 2, No 7 - FDA Approvals, News & Updates


Cetuximab (Erbitux, Bristol-Myers Squibb) received a new indication for the treatment of recurrent or metastatic squamous-cell carcinoma of the head and neck, in combination with chemotherapy. The approval was based on an international phase 3 clinical trial of 442 patientswithmetastatic or recurrent squamous-cell cancer of the head and neck who had not received chemotherapy.

Patients were randomized to chemotherapy plus cetuximab or to chemotherapy alone. Overall survival (OS) was 10.1 months with cetuximab plus chemotherapy compared with 7.4 months with chemotherapy alone. Cetuximab was associated with a higher incidence of diarrhea, respiratory and other infections, and serious infusion reactions. Cetuximab was originally approved in 2004 for epidermal growth factor receptor–positive late-stage colon cancer and in 2006 as first-line (in combination with radiation therapy) or second-line treatment for nonmetastatic head and neck cancer. (November 7, 2011)