FDA OKs Drug for Head & Neck Cancer
First New Drug for Cancers of the Head & Neck Since the 1950s
March 2, 2006 -- The FDA has approved Erbitux, a drug to help treat cancer
of the head and neck.
Erbitux is designed for use in combination with radiation therapy to treat
patients with squamous cell cancer of the head and neck (SCCHN) that cannot be
removed by surgery. It's the first drug approved for head and neck cancer that
has shown a survival benefit in this population, according the FDA.
The FDA also approved Erbitux to be used without other drugs (monotherapy)
in treating patients whose head and neck cancer has spread despite the use of
Head and Neck Cancers
Head and neck cancers are more common in men and in people over age 50.
Tobacco, including chewing tobacco, and alcohol are factors that increase
the risk of these cancers. Head and neck cancers affect the mouth, nose,
sinuses, and throat.
Because of the location of these cancers, people affected often have
significant problems with swallowing and speaking.
The FDA's Comments
"Patients suffering from all forms of cancer have a common goal -- to
treat the disease and prolong life," says Steven Galson, MD, MPH, in an FDA
news release. Galson directs the FDA's Center for Drug Evaluation and
"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," Galson continues.
"The approval of Erbitux monotherapy to shrink tumors in patients with
metastatic disease who no longer respond to other forms of treatment is also
important. Patients need as many effective treatment options as possible,"
First New Drug Approved in Decades
Erbitux, which received a priority review from the FDA, is the first drug
approved by the FDA 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 showing that Erbitux prolonged survival by more than a year and a half,
compared with treatment with radiation alone.
Approval of Erbitux monotherapy was based on evidence of tumor shrinkage in
13% of patients, lasting on average of six months.
Every year, about 29,000 new cases of head and neck cancer are diagnosed in
the U.S., according to the FDA.
Unlike many chemotherapy drugs that work by poisoning cancer cells, Erbitux
is an antibody. Erbitux blocks the effect of a major growth factor that is
responsible for causing cancers to grow.
Erbitux is also used in other cancers, such as colorectal cancer.