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news.The FDA has accepted for review a new drug application filed by Bayer AG and Onyx Pharmaceuticals for sorafenib, a potential treatment for advanced kidney cancer. The FDA has also granted priority review status to the application.
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Priority review designation essentially fast tracks the approval process for investigational agents that address unmet medical needs. Based on this designation, the FDA reviews the application with a goal of taking action within six months.
“This, along with our recent European filing, puts us ahead of schedule in our global regulatory strategy,” said Wolfgang Plischke, president of Bayer HealthCare’s Global Pharmaceutical Division.
The US submission, which was completed in July 2005, was based on an ongoing Phase III trial in patients with advanced kidney cancer. Results from the study, the largest randomized, placebo-controlled trial ever conducted in advanced renal cell cancer, were presented in May at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO).