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FDA Approves Stivarga to Treat Liver Cancer
FDA news release; 2017 Apr 27
The FDA expanded the approval of Stivarga (regorafinib) to include treatment of patients with hepatocellular carcinoma (HCC).
Indications: Stivarga is a kinase inhibitor indicated for the treatment of patients with HCC who have been previously treated with sorafenib.
Dosage and administration: Recommended dose: 160 mg orally, once daily for the first 21 days of each 28-day cycle.
Efficacy and safety: Safety and efficacy were determined in a randomized trial showing median overall survival for patients taking Stivarga was 10.6 months, vs 7.8 months for those taking a placebo. Median progression-free survival was 3.1 and 1.5 months, respectively. Overall response rate was 11% and 4%, respectively.
Side effects/risks: The most common adverse reactions are pain, hand-foot skin reaction, asthenia/fatigue, diarrhea, decreased appetite/food intake, hypertension, infection, dysphonia, hyperbilirubinemia, fever, mucositis, weight loss, rash, and nausea.
FDA expands approved use of Stivarga to treat liver cancer. [news release]. Silver Spring, MD: FDA April 27, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm555608.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed April 28, 2017.
Stivarga [package insert]. Wayne, NJ: Bayer HealthCare Pharmaceuticals Inc. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203085lbl.pdf. Accessed April 28, 2017.