The U.S. Food and Drug Administration (FDA) has approved Erbitux (cetuximab) for use with chemotherapy to aid in the treatment of patients with late-stage head and neck cancer.
The safety and effectiveness of Erbitux for this indication was based on results of a multicenter clinical study conducted outside the U.S. involving 442 patients with metastatic or recurrent head and neck cancer, according to the agency.
The study used a non-U.S. approved version of cetuximab, rather than the U.S.-approved formulation. Participants had inoperable or widespread disease and had not received prior chemotherapy. Half were selected to receive either the combination of cetuximab with chemotherapy or chemotherapy only.
Combined with chemotherapy, Erbitux extended the lives of patients who received the treatment combination more than those who received chemotherapy alone. Patients receiving cetuximab with chemotherapy lived, on average, 10.1 months, compared with 7.4 months for those receiving only chemotherapy.
Erbitux is already FDA-approved for certain types of colon cancer and has been approved since 2006 for the treatment of nonmetastatic head and neck cancer in combination with radiation therapy or as a single agent (following standard treatment).
