FDA Grants Priority Review to Regorafenib for Liver Cancer
The FDA has granted priority review status to the sNDA submitted by Bayer for regorafenib (Stivarga) as second-line therapy of hepatocellular carcinoma.
The U.S. Food and Drug Administration (FDA) has granted priority review status to the supplemental New Drug Application (sNDA) submitted by Bayer for regorafenib (Stivarga) as second-line systemic therapy of patients with advanced hepatocellular carcinoma (HCC), according to a press release from Bayer.1
The sNDA is based on findings from the ongoing, international, phase 3 RESOURCE trial (ClinicalTrials.gov Identifier: NCT01774344), which evaluated the efficacy and safety of regorafenib compared with placebo in 573 patients with HCC whose disease had progressed during treatment with sorafenib.
The study, which was presented during the European Society of Medical Oncology (ESMO) 18th World Congress on Gastrointestinal Cancer in Barcelona, showed that patients receiving regorafenib had a 38% reduced risk of death compared with those given placebo and best supportive care (hazard ratio [HR], 0.62; 95% CI, 0.50-0.78; P < .001); median overall survival was 10.6 months and 7.8 months, respectively.
Second-line treatment with regorafenib reduced the risk of progression or death by 54% (HR, 0.46; 95% CI, 0.37-0.56; P < .001) and time to disease progression by 56% (HR, 0.44; 95% CI, 0.36-0.55; P < .001) compared with placebo.
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Regorafenib is indicated for the treatment of patients with metastatic colorectal cancer, as well as for locally advanced, unresectable, or metastatic gastrointestinal stromal tumor previously treated with imatinib and sunitinib.
- FDA grants Bayer priority review for stivarga (regorafenib) for the second-line systemic treatment of liver cancer. Bayer website. http://www.bayer.us/en/article.php?id=123060. Published January 4, 2017. Accessed January 5, 2017.