Good Ph III data for Bayer/Onyx Nexavar

The New England Journal of Medicine has published pivotal Phase III trial data demonstrating that German drug major Bayer's and US firm Onyx Pharmacetuicals' co-developed Nexavar (sorafenib) doubled median progression-free survival in patients with advanced renal cell carcinoma, 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, director of the Experimental Therapeutics Program of the Cleveland Clinic Taussig Cancer Center in Cleveland, Ohio, USA. "This landmark study demonstrated the efficacy, tolerability and clinical benefit of Nexavar, which has rapidly become a valuable weapon against this devastating disease," he added.

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