Bayer and Onyx announce pivotal Nexavar kidney cancer study

Kidney Cancer :: Bayer and Onyx announce pivotal Nexavar kidney cancer study

Bayer Pharmaceuticals Corporation (NYSE: BAY) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that the New England Journal of Medicine has published their pivotal Phase III trial demonstrating that Nexavar (sorafenib) tablets doubled median progression-free survival (PFS) in patients with advanced renal cell carcinoma (RCC), or kidney cancer.

The data, as assessed by independent radiologic review, are from the Treatment Approaches in Renal Cancer Global Evaluation Trial (TARGET) ? the largest randomized controlled trial ever conducted in advanced RCC.

"Historically, patients with kidney cancer have had limited treatment options and there has been a particularly critical need for new therapies to help patients with advanced disease," said co-principal investigator Ronald Bukowski, M.D., Director of the Experimental Therapeutics Program of The Cleveland Clinic Taussig Cancer Center in Cleveland, OH. "This landmark study demonstrated the efficacy, tolerability and clinical benefit of Nexavar, which has rapidly become a valuable weapon against this devastating disease."

Based on these data, Nexavar was granted U.S. Food and Drug Administration (FDA) approval for the treatment of patients with advanced RCC, or kidney cancer, on December 20, 2005. Since then, Nexavar has been approved in nearly 50 countries.

"Nexavar was the first new drug approved for patients with advanced kidney cancer in over a decade," said Bill Bro, President and Chief Executive Officer of the Kidney Cancer Association (KCA). "With the advent of targeted therapies such as Nexavar, there has been remarkable change ? patients are experiencing improved outcomes without the toxic effects traditionally associated with chemotherapy."