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According to a press release from Bayer Pharmaceuticals and Onyx Pharmaceuticals, the U.S. Food and Drug Administration has approved Nexavar® (sorafenib) tablets for the treatment of patients with advanced renal cell (kidney) cancer.

The kidneys are each filled with tiny tubules that clean and filter the blood-the process that removes waste and makes urine. Renal cell cancer (RCC) is a malignancy involving these tubules of the kidney.

Treatment for renal cell carcinoma can be extensive and may produce poor outcomes. The four basic treatment options for renal cell carcinoma include: surgery, radiation, chemotherapy, and biologic therapy (biologic therapy uses substances made by the body or made in a laboratory that are used to boost, or direct, the patient’s own immune system to fight the cancer). Stem cell transplantation is also being evaluated for renal cell cancer. Nexavar is a new approach that targets enzymes involved in both tumor growth and tumor blood supply.

Nexavar was approved based on the results of a large phase III clinical trial of patients with advanced RCC. Compared to patients treated with placebo, patients treated with Nexavar survived for roughly twice as long without cancer progression: Median survival without evidence of cancer growth was six months among patients treated with Nexavar and three months among patients treated with placebo. At the time of these interim analyses, there was no significant difference in overall survival, but patients will continue to be followed.

The most common adverse treatment effects reported by study participants were diarrhea, rash, fatigue, hand-foot skin reaction, hair loss, nausea, itching, high blood pressure, vomiting, and loss of appetite. Grade 3 adverse effects were reported by 31% of patients treated with Nexavar and 22% of patients treated with placebo. Grade 4 adverse effects were reported by 7% of patients treated with Nexavar and 6% of patients treated with placebo.

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Nexavar is also being evaluated in phase III clinical trials for the treatment of advanced hepatocellular carcinoma (liver cancer) and metastatic melanoma. A phase III trial of Nexavar for the treatment of non-small cell lung cancer is planned for 2006.

Reference: Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc. Press Release: FDA Approves Nexavar® for Treatment of Patients with Advanced Kidney Cancer. December 20, 2005. Available at (Accessed December 21, 2005).

Related News:

Sorafenib® May be Available for Patients with Advanced Renal Cell Carcinoma (6/14/05)

Sorafenib Improves Outcome of Metastatic Renal Cell Carcinoma (5/20/05)

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