Bayer/Onyx Pharmaceuticals: Nexavar Approved for Kidney Cancer in Japan

Nexavar has been approved in Japan for use in metastatic renal cell carcinoma patients. This makes Nexavar the first oral targeted therapy to be approved in this major pharmaceutical market for this indication. This approval will significantly advance the outcomes of patients affected with renal cell carcinoma as well as further enhance Nexavar’s success.

Nexavar (sorafenib) is a multi-kinase inhibitor that targets angiogenesis and cell proliferation mediators such as Raf kinase, the platelet-derived growth factor receptor (PDGFR) family and the vascular endothelial growth factor receptors (VEGFR) 2 and 3. It was the first targeted therapy to be approved for metastatic renal cell carcinoma (RCC) in the US in December 2005 with subsequent EU approval in July 2006.

Approval was based on results from a randomized Phase III trial of more than 900 metastatic RCC patients which showed that Nexavar slowed tumor progression by 24 weeks compared to 12 weeks in the placebo group. However, it remains to be seen if this tumor growth suppression translates into a survival benefit for these patients.

Kidney cancer affects over 200,000 people annually worldwide with about a third of patients presenting with metastatic disease. Renal cell carcinoma is the most common form of kidney cancer and accounts for around 8,000 new cases per year in Japan alone.

RCC has been associated with high levels of unmet need and traditional cytokine therapy produces very low response rates. This presented a strong demand for better alternatives in advanced patients. The approval of targeted therapies such as Nexavar, Pfizer’s Sutent (sutinib) and Wyeth’s Torisel (temsirolimus) for RCC in recent years has positively widened the treatment options available for these patients.

Nexavar competes with Sutent and Torisel in the US (Sutent approved January 2006; Torisel approved May 2007) and EU (Sutent approved July 2006) metastatic RCC markets. However, with its most recent approval in Japan, Nexavar will be able to exclusively penetrate this market as it is the first oral targeted therapy to be approved here. Bayer and Onyx Pharmaceuticals co-develop Nexavar worldwide, except in Japan where it is developed and marketed by Bayer.

Nexavar is also approved in both the US and EU for advanced hepatocellular carcinoma. In September 2007, a new drug application for Nexavar was filed for use in patients with hepatocellular carcinoma in Japan for which priority review status has been recently granted. Approval in this additional indication will no doubt further boost Nexavar’s success in this major pharmaceutical market.