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News From the Food and Drug Administration
June 6, 2017

Liver Cancer Treatment Approved

JAMA. 2017;317(21):2157. doi:10.1001/jama.2017.6339

Regorafinib is now approved to treat patients with hepatocellular carcinoma in addition to previously approved indications for advanced gastrointestinal stromal tumors and metastatic colorectal cancer that no longer respond to treatment.

Marketed as Stivarga, the drug is the first approved for liver cancer in nearly a decade. It is intended for patients who have stopped responding to initial treatment with sorafenib. Regorafinib is a kinase inhibitor that blocks several cancer-promoting enzymes, including some in the vascular endothelial growth factor pathway. The drug’s safety and efficacy for use in treating liver cancer were tested in a trial involving 573 patients whose tumors had progressed after treatment with sorafenib.