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Home Industry News Bayer and Onyx get Nexavar FDA approval

Bayer and Onyx get Nexavar FDA approval

22nd December 2005

Kidney cancer drug Nexavar has received approval from the US Food and Drug Administration (FDA).

The treatment developed by Bayer Healthcare and Onyx Pharmaceuticals is the first in over ten years for advanced renal cell carcinoma. It was approved after a trial, which involved 130 cancer centres, found that survival rates were doubled with the drug.

On receipt of the announcement, Bayer said that the drugs would be shipped to “specialist pharmacies” within 24 hours from Wednesday. The companies will now pursue regulatory clearance in the EU through the EMEA.

“The FDA approval of Nexavar is a crucial step for patients with advanced kidney cancer therapy,” said Werner Wenning, chairman of Bayer’s board of management.

The chairman of Bayer Healthcare’s executive committee Arthur Higgins added: “We are thankful to all of the RCC investigators and patients that have been involved, and are hopeful that Nexavar will become a promising therapeutic option for other malignant tumours as well.”

Nexavar works by inhibiting kinase enzymes involved in tumour growth and blood supply.

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