The FDA says in its announcement Thursday that this is the first drug approved for head and neck cancer that has shown a survival benefit in this population.
Erbitux is also approved for use alone to treat patients whose head and neck cancer has spread despite the use of standard chemotherapy.
Steven Galson, MD, Director of FDA's Center for Drug Evaluation and Research, says in a statement, "Patients suffering from all forms of cancer have a common goal - to treat the disease and prolong life. We consider this approval an important advance in the treatment of head and neck cancer because it has been shown to help some patients live longer."
Erbitux is the first FDA endorsed drug for the 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.
Erbitux monotherapy's approval 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 FDA says 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.
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 head and neck cancer, Erbitux helped to shrink the patients' tumors after they no longer responded to platinum-based therapy, the current standard treatment for patients with this difficult to treat disease.
