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FDA Grants Regorafenib Priority Review in Liver Cancer

Jason M. Broderick @jasoncology
Published: Wednesday, Jan 04, 2017

Dario Mirski, MD

Dario Mirski, MD

The FDA has granted a priority review to a supplemental new drug application (sNDA) for the use of regorafenib (Stivarga) as a second-line treatment for patients with unresectable hepatocellular carcinoma (HCC), according to Bayer, the manufacturer of the multikinase inhibitor.

Regorafenib is an oral kinase inhibitor that blocks VEGFR 1-3, TIE-2, RAF-1, BRAF, BRAFV600, KIT, RET, PDGFR, and FGFR. The agent is currently FDA approved for the treatment of patients with metastatic colorectal cancer and advanced gastrointestinal stromal tumors.
Bruix J, Merle P, Granito A, et al. Efficacy and safety of regorafenib versus placebo in patients with hepatocellular carcinoma (HCC) progressing on sorafenib: results of the international, randomized phase 3 RESORCE trial. Presented at: 2016 World Congress on GI Cancer; June 28 - July 2, 2016; Barcelona, Spain. Abstract LBA03.

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