First FDA Approved Treatment in this Indication in More Than a Decade
Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc. recently announced that the FDA has approved Nexavar® (sorafenib) tablets for the treatment of patients with advanced renal cell carcinoma (RCC), or kidney cancer. Nexavar, which has been shown to double progression-free survival in patients with advanced RCC, is the first FDA-approved treatment for this type of cancer in more than a decade.
“Nexavar is an oral anticancer drug that blocks tumor growth in new ways,” said Arthur Higgins, Chairman of Bayer HealthCare’s Executive Committee. “It has demonstrated the ability to prolong progression-free survival. Nexavar also has been shown to delay the progression of cancer in the majority of patients with a manageable side effect profile — an area that has been a challenge for patients and their physicians.””The approval of Nexavar reflects the culmination of 12 years of hard work by countless dedicated scientists and clinicians, as well as the selfless participation of individuals suffering with advanced kidney cancer,” said Hollings C. Renton, Chairman, President and Chief Executive Officer of Onyx Pharmaceuticals, Inc. “We thank all of these groups for their important contributions to Nexavar’s development.”
As part of the global registration strategy, a Marketing Authorization Application (MAA) was also submitted to the European Medicines Agency (EMEA) in London in September 2005 for approval to market Nexavar within the European Union for the treatment of RCC. In addition, filings have been completed in Switzerland, Australia, Brazil, Canada, and Mexico.
