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FDA OKs Drug for Head & Neck Cancer

First New Drug for Cancers of the Head & Neck Since the 1950s

Safety, Effectiveness

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.

Side Effects

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.

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