Sorafenib Accepted Into FDA Pilot 1 Program

May 4, 2005

Bayer Pharmaceuticals and Onyx Pharmaceuticals have announced that sorafenib (formerly BAY 43-9006) has been accepted into the FDA's Pilot 1 Program for continuous marketing applications.

The Pilot 1 Program was designed for therapies that have been granted fast-track status by the FDA and that have the potential to provide important therapeutic benefit over available therapy. Sorafenib was granted fast-track status for metastatic renal cell carcinoma (RCC), or kidney cancer, in March 2004.