Erbitux Now Approved for Head and Neck Cancers

Article date: March 2, 2006

Improves Survival When Used With Radiation

The US Food and Drug Administration has approved the drug Erbitux (cetuximab) for certain patients with cancers of the head and neck. It's the first drug approved for these patients that actually helps them live longer, the agency said.

Erbitux can now be given along with radiation as a first line therapy for people with early stage cancers of the oropharynx and hypopharynx or larynx that cannot be removed by surgery. In a clinical trial, patients who got both treatments survived about 49 months, while those who got only radiation therapy survived about 29 months. The drug also delayed tumor growth. The FDA said that result is important because growing tumors can cause pain and difficulty swallowing, eating, and speaking.

"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," said Steven Galson, MD, director of the FDA's Center for Drug Evaluation and Research. "Patients need as many effective treatment options as possible."

The FDA also approved Erbitux for use by itself in patients whose head and neck cancer has spread and no longer responds to chemotherapy. A separate clinical trial showed the drug could shrink tumors in these patients.

Erbitux is manufactured by ImClone Systems and Bristol-Myers Squibb. It is already approved to treat some patients with advanced colorectal cancer. It works by blocking a protein tumors need to grow.

The drug is given into a vein. Side effects can include skin rash, fever, chills, fatigue, and nausea. The manufacturers said Erbitux should be used cautiously in people who have heart disease, congestive heart failure, or abnormal heart rhythms.

Reviewed by: Members of the ACS Medical Content Staff

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