Germany’s Bayer and US biotechnology partner, Onyx Pharmaceuticals, say that they have completed the filing of their New Drug Application for sorafenib (formerly known as BAY 43-9006) for the treatment of patients with advanced renal cell carcinoma, or kidney cancer.

The submission is based on an ongoing Phase III trial in which patients with advanced kidney cancer treated with sorafenib survived twice as long as those receiving placebo. A similar trial is set to start in Europe shortly, and Bayer and Onyx are in discussions with regulators about similar programs in other territories.

Sorafenib has been granted fast track status [[07/04/04e]], and the two companies hope to be able to launch the drug in the first half of next year.