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The FDA granted priority review to regorafenib tablets as a second-line systemic treatment for patients with hepatocellular carcinoma, according to the drug’s manufacturer.
The review is based on results from the international, multicenter, placebo-controlled phase 3 RESORCE trial, in which 573 patients with hepatocellular carcinoma (HCC) who previously had disease progression during treatment with sorafenib (Nexavar, Bayer) were randomly assigned (2:1) to receive regorafenib (Stivarga, Bayer) or placebo plus best supportive care.
Patients received 160 mg of regorafenib or placebo once daily for 3 weeks, followed by 1 week of no treatment, for 28-day treatment cycles.
OS [overall survival] served as the primary endpoint. Secondary endpoints included time to progression, PFS, objective tumor response rate and disease control rate.