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FDA Approves Regorafenib for Liver Cancer

Dr. Richard Pazdur from the FDA's Center for Drug Evaluation and Research

Richard Pazdur, MD

The FDA has approved regorafenib (Stivarga) as a second-line treatment for patients with hepatocellular carcinoma (HCC) who have previously received sorafenib (Nexavar).

The approval of the the multikinase inhibitor is based on the phase III RESORCE trial, in which the median overall survival (OS) was 10.6 months with regorafenib plus best supportive care compared with 7.8 months for placebo plus best supportive care, representing a 38% reduction in the risk of death (HR, 0.62; 95% CI, 0.50-0.78; P <.001).

"Limited treatment options are available for patients with liver cancer,” Richard Pazdur, MD, acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and director of the FDA’s Oncology Center of Excellence, said in a statement. “This is the first time patients with HCC have had an FDA-approved treatment that can be used if their cancer has stopped responding to initial treatment with sorafenib.” Click here to read the full article at

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