Nexavar granted US approval

Published: 3-Jan-2006
Regulatory


The US Food and Drug Administration (FDA) has approved Bayer HealthCare's Nexavar (sorafenib) tablets for the treatment of patients with advanced renal cell carcinoma (RCC), or kidney cancer. The tablets will be shipped, primarily to specialty pharmacies and made available to patients 'within days'.

Co-developed by Bayer HealthCare based in Germany and Onyx Pharmaceuticals in the US, Nexavar has been shown to double progression-free survival in patients with advanced RCC. This is the first FDA-approved treatment for this type of cancer in more than a decade.

Werner Wenning, chairman of the board of management of Bayer said the approval 'marks a great success for the realignment of our pharmaceuticals business and a major accomplishment in the commercial realisation of the company's oncology franchise'.

The FDA judgement was based on data from the largest ever randomised, placebo-controlled, international trial in patients with advanced renal cell carcinoma, in which 130 centres participated.

The company has also filed for regulatory approval with the European Medicines Evaluation Agency and also with authorities in Switzerland, Australia, Brazil, Canada and Mexico.

The company hopes that Nexavar will become a therapeutic option for other malignant tumours as well. The drug is currently in Phase III clinical trials for treatment of advanced hepatocellular carcinoma (liver cancer) and metastatic melanoma (skin cancer). A Phase III clinical trial in non-small cell lung cancer is planned for the first half of 2006.

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