FDA Expands Approved Use of Stivarga

The approved use of Stivarga (regorafinib) was recently expanded by the US Food and Drug Administration (FDA) to included patients with hepatocellular carcinoma (HCC) who have been treated with sorafenib in the past. This is the first treatment for liver cancer approved by the FDA in almost a decade. The drug is also approved to treat colorectal cancer and gastrointestinal stromal tumors that are no longer responding to prior treatments.

Stivarga is a kinase inhibitor and works by blocking several enzymes, including ones in the vascular endothelial growth factor pathway, that promote cancer growth.
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The FDA approved Stivarga based on the results of a randomized trial that included 573 patients with HCC whose tumors had progressed after receiving sorafenib. In patients receiving Stivarga, the median overall survival was 10.6 months and the median progression-free survival was 3.1 months compared with 7.8 months and 1.5 months for patients in the placebo group, respectively. The overall response rate was 11% for patients taking Stivarga compared with 4% for patients taking placebo.

The most common adverse effects associated with Stivarga were pain, hand-foot skin reaction, fatigue, diarrhea, decreased appetite, weight loss, hypertension, infection, dysphonia, hyperbilirubinemia, fever, mucositis, rash, and nausea. In addition, Stivarga was associated with serious risks, such as hepatotoxicity, infections, hemorrhage, gastrointestinal perforation or fistula, dermatologic toxicity, hypertension, cardiac ischemia and infarction, reversible posterior leukoencephalopathy syndrome, and wound healing complications.

—Melissa Weiss

Reference:

FDA expands approved use of Stivarga to treat liver cancer [press release]. FDA. April 27, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm555608.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.