Bayer/Onyx' Nexavar cleared by Swissmedic
German drugmaker Bayer and the USA's Onyx Pharmaceuticals say that the Swiss drug regulatory agency, Swissmedic, has approved their co-developed cancer drug Nexavar (sorafenib) for the treatment of patients with advanced renal cell carcinoma after nepherectomy and prior palliative or adjuvant therapy with cytokines. Nexavar, which has been shown to double progression-free survival in patients with advanced RCC, will be marketed by Bayer in Switzerland and was approved by US regulators in December 2005. Bayer filed for approval of the drug, which has predicted peak annual sales of $1.2 billion, with the European Medicines Agency and, if it is cleared, is expected to go on sale in the second half of the year.
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