Regorafenib is only the second agent approved by the FDA for the treatment of patients with advanced-stage hepatocellular carcinoma. Herein, we discuss the evidence that led to the approval of this agent. Examination of this process reveals important challenges associated with drug regulation, relating to trial design, treatment toxicity, and real-world clinical benefit.
Refers to U.S. Food and Drug Administration. FDA expands approved use of Stivarga to treat liver cancer. FDAhttps://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm555608.htm (2017)