FDA NEWS RELEASE

FDA Approves New Treatment for Advanced Kidney Cancer

The Food and Drug Administration (FDA) today approved Nexavar (sorafenib tosylate), a new anti-cancer medicine used to treat adults with advanced renal cell carcinoma, the most common type of kidney cancer.

"The approval of Nexavar to treat advanced kidney cancer brings a much needed option for this group of cancer patients," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research (CDER). "FDA is working hard to support the development of new and effective treatments for patients with cancer and other serious illnesses who have limited alternatives."

In the United States, kidney cancer accounts for approximately 3 percent of all adult cancers. According to the American Cancer Society, about 32,000 new cases are diagnosed and about 12,000 people die from the disease annually. Kidney cancer occurs most often in people between the ages of 50 and 70, affects men almost twice as often as women and, if detected early enough, may be curable surgically. However, tumors that are advanced (i.e., cannot be surgically removed or have spread to other parts of the body) are difficult to treat.

Two studies in patients with advanced kidney cancer have shown that patients treated with Nexavar had more time before tumor progression or death. In the larger study, most patients had previously received treatment with interleukin-2 or interferon. The median time to tumor progression or death in the Nexavar treated arm was 167 days compared to 84 days in people not treated with the drug.

Some common temporary side effects reported with Nexavar are rash, diarrhea, increases in blood pressure, and redness, pain swelling, or blisters on the palms of the hands or soles of the feet.

Nexavar will be distributed and marketed by Bayer Pharmaceuticals Corporation of Westhaven, CT.

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