27 April 2017 - The U.S. FDA today expanded the approved use of Stivarga (regorafenib) to include treatment of patients with hepatocellular carcinoma who have been previously treated with the drug sorafenib. This is the first FDA approved treatment for a liver cancer in almost a decade.
This Stivarga application was granted Priority Review designation, under which the FDA’s goal is to take action on an application within six months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.
This indication for Stivarga also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.