November 19, 2007 / 1:58 PM / 12 years ago

UPDATE 1-Bayer's Nexavar gets U.S. FDA nod for liver cancer

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FRANKFURT, Nov 19 (Reuters) - The U.S. Food and Drug Administration (FDA) has approved Nexavar medicine to treat liver cancer, Bayer AG BAYG.DE and Onyx Pharmaceuticals Inc ONXX.O said on Monday, extending the reach of their cancer drug.

The two companies said this was the second time in two years that Nexavar had been granted approval on a priority review basis, making it rapidly available to patients who previously had limited treatment options.

“Nexavar, an oral anti-cancer drug, is the first approved systemic drug therapy for liver cancer and the only drug therapy shown to significantly improve overall survival in patients with the disease,” the companies said in a statement.

Nexavar — one of Bayer’s top drug hopes — is already approved in Europe and the United States for kidney cancer.

Bayer won approval from the European Commission to sell Nexavar for liver cancer treatment last month.

Bayer shares traded up 0.1 percent at 54.11 euros at 1346 GMT, having hit an intra-day low at 53.60 euros. The German blue-chip DAX index .GDAXI was down 0.8 percent.

Nexavar became the first medicine to extend the life of patients with advanced liver cancer in a large study — adding about three months to survival compared with a placebo — according to trial results released in June.

Liver cancer kills more than 600,000 people globally each year and is currently treated with limited success using a mix of surgery, radiation and chemotherapy.

Nexavar, known generically as sorafenib, comes in a pill form. It is also being tested against several other types of cancer, including non-small cell lung cancer and breast cancer.

Bayer has said it expects the drug to reach 1 billion euros ($1.46 billion) in annual sales if it gets approvals for treatment of various cancer indications.

Last year Nexavar sales reached 130 million euros. (Reporting by Mantik Kusjanto; Editing by David Holmes)

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