BAYER AND ONYX'S NEXAVAR RECEIVES FAST-TRACK DESIGNATION

Bayer and Onyx Pharmaceuticals announced that Nexavar (sorafenib) has been granted fast-track designation by the FDA for the treatment of advanced melanoma, a form of skin cancer. Nexavar was approved by the FDA in December 2005 for advanced renal cell carcinoma.

The fast-track program is designed to expedite the review of drug compounds for the treatment of patients with serious or life-threatening diseases where there is an unmet medical need for new therapeutic approaches and where the product has the potential to demonstrate an effect on a serious or life-threatening aspect of the condition. The designation allows a company to file a new drug application on a rolling basis as data become available. With fast-track designation, there may be the possibility of a priority review, which could decrease the typical review period.