FDA OKs Drug for Head & Neck Cancer
First New Drug for Cancers of the Head & Neck Since the 1950s
Two studies established Erbitux's safety and effectiveness.
One study included 424 patients with head and neck cancer. Using Erbitux in
combination with radiation therapy showed a survival time of four years vs.
nearly 2.5 years on radiation therapy alone. Tumors also grew slower in the
group that got Erbitux and radiation.
In head and neck cancer, tumor growth is associated with pain and
difficulties with swallowing, speaking, and eating. Controlling tumor growth
for as long as possible is important for patients' well-being.
The second study included 103 patients with recurrent or metastatic SCCHN.
Erbitux helped to shrink the patients' tumors after the tumors no longer
responded to platinum-based therapy, the 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, and nausea, states the FDA.
Radiation's common side effects -- such as sore mouth, trouble swallowing,
and radiation-related skin changes -- were similar in frequency in patients
receiving Erbitux plus radiation and those receiving radiation alone.
Erbitux is manufactured by ImClone Systems Inc. and will be distributed and
marketed by Bristol-Myers Squibb Co.