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Published on 21 November 2007

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FDA approves Nexavar in the US

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The Food and Drug Administration (FDA) has approved Nexavar (sorafenib) for use in the US, the manufacturer has announced.

German pharmaceutical company Bayer said the drug has been authorised by the regulator to treat liver cancer.

The FDA extended the approval of the oral anticancer drug for the treatment of patients with the most common form of liver cancer.

The drug has already been approved in Europe for the treatment of the condition, and has been approved for advanced kidney cancer in more than 60 countries, including the US and the EU.

Arthur Higgins, chairman of Bayer HealthCare AG, said: “This milestone will likely establish Nexavar as the standard systemic therapy for the treatment of liver cancer and shows the dedication of health authorities to make Nexavar available as quickly as possible.

“Most importantly, it allows us to offer patients and medical professionals the potential to improve treatment outcomes for this devastating disease.”

Hollings Renton, chairman of Onyx Pharmaceuticals, added: “Liver cancer is one of the cancers in which the number of related deaths continues to increase.

“This second approval for Nexavar – first in advanced kidney cancer and now, less than two years later in hepatocellular carcinoma – demonstrates our commitment to expediting the clinical development of this innovative therapy to treat today’s unmet needs in cancer.”

Copyright © PA Business 2007

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