The US Food and Drug Administration (FDA) has expanded the indication for Stivarga (regorafenib) to now include treatment for patients with hepatocellular carcinoma (HCC) who have previously been treated with the drug Nexavar.
Expansion of Stivarga, ‘s indication marks the first FDA-approved treatment for a liver cancer in almost a decade.
Stivarga is an oral multikinase inhibitor that has shown antiangiogenic activity. It is already approved for the treatment of metastatic colorectal cancer and gastrointestinal stromal tumors that cannot be surgically removed.
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The expanded approval for use in liver cancer was based on the results of a comparative clinical trial that included 573 patients with progressive HCC who had previously undergone treatment with Nexavar.
Median overall survival was 10.6 months in the Stivarga group compared with 7.8 months in those receiving placebo, representing a significant reduction in the risk for death. The median progression-free survival was also significantly longer in the Stivarga.
This application for expanded use in liver cancer was granted priority review designation. This indication also received orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
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