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Regorafenib Approved for Hepatocellular Carcinoma

THURSDAY, April 27, 2017 -- U.S. Food and Drug Administration approval of the kinase inhibitor regorafenib (Stivarga) has been expanded to include hepatocellular carcinoma, the agency said Thursday in a news release.

Regorafenib is the first drug approved to treat hepatocellular carcinoma in nearly a decade, the FDA said. Regorafenib is already FDA-approved to treat colorectal cancer and gastrointestinal stromal tumors, the agency said. The drug was approved for hepatocellular carcinoma patients treated previously with sorafenib.

Regorafenib's effectiveness for treating hepatocellular carcinoma was evaluated in a randomized trial of 573 people whose tumors had progressed despite treatment with sorafenib. The most common adverse events included gastrointestinal and abdominal pain, skin reactions, fatigue, diarrhea, loss of appetite, hypertension, and infection. More serious adverse events included hepatotoxicity, hemorrhage, gastrointestinal perforation or fistula, and cardiac ischemia and infarction.

Women who are pregnant or breastfeeding should not take regorafenib, the FDA said. And patients of both genders of child-bearing age who take the drug should use contraception, the agency added.

Approval of Stivarga was granted to Bayer HealthCare Pharmaceuticals, based in Whippany, New Jersey.

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Posted: April 2017

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