The application has been submitted under the European Medicines Agency’s (EMEA’s) centralized procedure for product approval, which provides review and approval for all countries within the EU.
The companies have also initiated a single-arm phase III trial in the EU for patients with advanced kidney cancer that have been previously treated. The study, to be managed by Bayer, will take place at sites in 11 EU countries including Germany, France, UK, Spain, Italy, the Netherlands, and Poland, and is scheduled to begin this fall.
“The filing of our marketing authorization application is an important step towards making sorafenib available to doctors and patients in the EU,” said Wolfgang Plischke, president of Bayer HealthCare’s global pharmaceutical division. “In the meantime, the initiation of the trial will provide advanced RCC (renal cell carcinoma) patients with access to this innovative anticancer drug candidate.”
Bayer and Onyx also completed the submission of a new drug application with the FDA for sorafenib for patients with advanced kidney cancer in July 2005.