Bayer HealthCare and Onyx have announced that the supplemental New Drug Application (sNDA) for sorafenib tablets (Nexavar), indicated for patients with hepatocellular carcinoma (HCC), has been accepted for review and has been granted priority review status by the FDA. HCC is the most common form of liver cancer.
Sorafenib is approved in more than 50 countries for the treatment of patients with advanced kidney cancer. It targets both the tumor cell and tumor vasculature. If approved, this agent would be the first FDA-approved therapy for HCC.
The Phase 3 SHARP trial showed that the medication extended overall survival by 44% in patients with HCC compared with those receiving placebo.
(Sources: Bayer HealthCare/Onyx, August 20, 2007