The FDA ( U.S. Food and Drug Administration ) approved Erbitux ( Cetuximab ) for use in combination with radiation therapy to treat patients with squamous cell cancer of the head and neck ( SCCHN ) that can not be removed by surgery.

Erbitux, which received a priority review, is the first drug approved to treat head and neck cancer since methotrexate became available in the 1950s.

Approval of Erbitux in combination with radiation therapy was based on a study that showed it prolonged survival by 20 months compared to treatment with radiation alone.
Approval of Erbitux monotherapy was based on evidence of tumor shrinkage in 13 percent of patients, lasting on average of 6 months.

Standard cancer statistics databases estimate that there are about 29,000 new cases of head and neck cancer diagnosed every year in the United States.

The safety and effectiveness of Erbitux was established in two studies.
The randomized clinical trial of 424 patients using Erbitux in combination with radiation therapy showed a survival time of 49 months versus 29.3 months on radiation therapy alone.
In addition, delay in tumor growth was observed with the use of Erbitux and radiation, compared to radiation alone.
In a second trial of 103 patients with recurrent or metastatic SCCHN, Erbitux helped to shrink the tumors after the tumors no longer responded to platinum-based therapy, the current standard treatment for patients with this difficult to treat disease.

Commonly reported side effects of Erbitux were infusion reactions ( fever, chills ), skin rash, fatigue/malaise, nausea.
The common side effects associated with radiation such as sore mouth, trouble swallowing, and radiation skin changes were similar in frequency in patients receiving Erbitux plus radiation and those receiving radiation alone.

Source: FDA, 2006


XagenaMedicine2006