The US Food and Drug Administration (FDA) has approved Bayer Healthcare and Onyx Pharmaceuticals' 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 tumour growth in new ways. 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," said Arthur Higgins, chairman of Bayer HealthCare's executive committee.

"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.

According to a company release, Nexavar's FDA approval was based on phase III data from the largest randomized, placebo-controlled trial ever conducted in patients with advanced renal cell cancer. In the phase III study, Nexavar doubled progression-free survival (PFS) when compared to placebo.

As part of the global registration strategy, a marketing authorisation 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.

Nexavar is the first oral multi-kinase inhibitor that targets serine/threonine and receptor tyrosine kinases in both the tumour cell and tumour vasculature.