ROCKVILLE, March 2 - The FDA has approved Erbitux (cetuximab) for treatment of advanced squamous cell cancer of the head and neck.
The ImClone drug was indicated for use in combination with radiation therapy for patients with unresectable cancers. It was also approved as monotherapy for treatment of squamous cell cancer of the head and neck that has metastasized following standard platinum-based chemotherapy.
The FDA action marks the first time in 45 years, since it allowed methotrexate on the market, that it has approved a drug for treatment of this type of head-and-neck cancer.
Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research, said the approval marks an important advance in head-and-neck cancer treatment because Erbitux has been shown to help some patients live longer.
Moreover, he said Erbitux monotherapy has been shown to shrink tumors in people with metastatic disease.
Erbitux, which received a priority review, was approved on the basis of results of a clinical trail of 424 patients that demonstrated a 20-month advantage for those treated with Erbitux plus radiation compared with patients treated with radiation alone.
In that trial, Erbitux also slowed tumor growth, which reduced symptoms such as pain as well as difficulty in swallowing, speaking, or eating.
The approval for metastatic disease was based on clinical trial of 103 patients in there was evidence of tumor shrinkage lasting an average of six months in 13% of patients treated with Erbitux. Patients in that trial no longer responded to platinum-based chemotherapy, which is the standard treatment for metastatic disease.
Commonly reported side effects of Erbitux were infusion reactions (fever and chills), skin rash, fatigue/malaise, and 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.
Erbitux is manufactured by ImClone Systems of, Branchburg, N.J., and will be distributed and marketed by Bristol-Myers Squibb of Princeton, N.J.