(Nov. 7, 2011) The U.S. Food and Drug Administration approved Erbitux (cetuximab) for use with chemotherapy to treat patients with late-stage (metastatic) head and neck cancer.
Combined with chemotherapy, Erbitux extended the lives of those receiving the treatment combination compared with those receiving chemotherapy alone. Erbitux already is FDA-approved for certain types of colon cancer, and has been approved since 2006 for treatment of non-metastatic head and neck cancer in combination with radiation therapy (first-line) or as a single agent (following standard treatment).
According to the National Cancer Institute, head and neck cancers account for 3 percent to 5 percent of all cancers in the
. These cancers typically develop in the nose, throat or mouth and they are more common in men and in people older than 50. United States
The safety and effectiveness of Erbitux for this indication is based on the results of a multi-center clinical study conducted outside the
involving 442 patients with metastatic or recurrent head and neck cancer. The study used a non-U.S. approved version of cetuximab, rather than the U.S.-approved formulation. United States
Erbitux was first approved by the FDA in 2004 to treat Epidermal Growth Factor Receptor (EGFR)-positive late-stage colon cancer after patients stopped responding to chemotherapy. The treatment can be used alone or in combination with chemotherapy.