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FDA expands approved use of regorafinib to treat liver cancer

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FDA has expanded the approved use of regorafinib (Stivarga—Bayer HealthCare Pharmaceuticals) to include treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This is the first FDA-approved treatment for a liver cancer in nearly 10 years.

FDA has expanded the approved use of regorafinib (Stivarga—Bayer HealthCare Pharmaceuticals) to include treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This is the first FDA-approved treatment for a liver cancer in nearly 10 years. In addition, noted Richard Pazdur, MD, acting director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research and director of FDA's Oncology Center of Excellence, "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." Regorafinib, a kinase inhibitor, is also approved for the treatment of colorectal cancer and gastrointestinal stromal tumors that no longer respond to previous treatments. A randomized trial involving 573 patients with HCC whose tumors had progressed after receiving sorafenib found the median overall survival time for patients taking regorafinib was 10.6 months, compared with 7.8 months for patients taking a placebo. Additionally, the median progression-free survival for patients taking regorafinib was 3.1 months, compared with 1.5 months for those receiving a placebo, while the overall response rate in the treatment group was 11%, compared with 4% in the placebo group. Common adverse effects of regorafinib included pain, hand-foot skin reaction, fatigue, diarrhea, decreased appetite, hypertension, infection, dysphonia, hyperbilirubinemia, fever, mucositis, weight loss, rash, and nausea. Regorafinib is also associated with serious risks, including hepatotoxicity, infections, heavy bleeding, gastrointestinal perforation or fistula, dermatologic toxicity, cardiac ischemia and infarction, reversible posterior leukoencephalopathy syndrome, and wound healing complications. The drug should not be taken by women who are pregnant or breastfeeding, as it may cause harm to a developing fetus or a newborn baby.

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https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm555608.htm

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