FDA Expands Approval of Stivarga for Liver Cancer

The FDA has expanded the approved use of regorafenib, (Stivarga, Bayer HealthCare Pharmaceuticals Inc.) to include the treatment of patients with hepatocellular carcinoma (HCC or liver cancer) who have been previously treated with the drug sorafenib (Nexavar).

The approval is based on data of the safety and efficacy of Stivarga for the treatment of patients with HCC from a randomized study that included 573 patients with HCC whose tumors had progressed after receiving sorafenib. The trial measured the length of time that patients lived after receiving treatment (overall survival), the length of time tumors did not grow after treatment (progression-free survival), and the percent of patients whose tumors completely or partially shrank after treatment (overall response rate).

The median overall survival for patients receiving Stivarga was greater (10.6 months) than those who received a placebo (7.8 months). Patients taking Stivarga also demonstrated a greater median progression-free survival (3.1 months) compared to the placebo group (1.5 months), and a greater response rate (11%) compared to the 4% of patients taking a placebo.

Stivarga is also approved for the treatment of colorectal cancer and gastrointestinal stromal tumors that are no longer responding to previous treatments.

Common adverse effects include pain, hand-foot skin reaction, fatigue, diarrhea, decreased appetite, high blood pressure, infection, difficulty speaking, high levels of bilirubin in the blood, fever, inflammation of the mucous membranes, weight loss, rash, and nausea.

Reference

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