Bayer AG - Stockholders' Newsletter Second Quarter 2007

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Phase III study:
Nexavar® extends overall survival by 44 percent in liver cancer patients

Bayer employee David Milczanowski at the pressure filter in the production facility for sorafenib, the active ingredient in the cancer treatment Nexavar®.

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Bayer employee David Milczanowski at the pressure filter in the production facility for sorafenib, the active ingredient in the cancer treatment Nexavar®.

Berlin. Nexavar® (sorafenib), which has already been granted regulatory approval for the treatment of renal cell carcinoma (kidney cancer), can extend the overall survival rate in patients with hepatocellular carcinoma, or primary liver cancer, by 44 percent. This was the result of a Phase III clinical study carried out by Bayer HealthCare und Onyx Pharmaceuticals, Inc. who are jointly developing this medicine to treat various types of cancer. The results were presented at the 43rd annual meeting of the American Society of Clinical Oncology in Chicago.

The international, Phase III, placebo-controlled trial randomized and evaluated 602 liver cancer patients who had no prior systemic therapy at sites in the Americas, Europe, Australia and New Zealand. The primary objective of the study was to compare overall survival in patients administered Nexavar® versus those administered placebo. Median overall survival was 10.7 months in Nexavar®-treated patients compared to 7.9 months in those taking placebo. Based on the strength of the data, regulatory approvals are being sought from the U.S. Food and Drug Administration and the European Medicines Agency. Nexavar® is already approved in 50 countries for the treatment of advanced kidney cancer.