FDA Grants Priority Review for the sNDA for Regorafenib in the Second-Line Systemic Treatment of Liver Cancer

On January 4, the U.S. Food and Drug Administration (FDA) granted Priority Review status for the supplemental New Drug Application (sNDA) for regorafenib (Stivarga) tablets for the second-line systemic treatment of patients with hepatocellular carcinoma in the United States.

“Liver cancer is one of the few cancers still on the rise, and though sorafenib has been approved for the treatment of patients with unresectable hepatocellular carcinoma since 2007, effective second-line systemic treatment options are urgently needed,” said Dario Mirski, MD, Bayer's Senior Vice President and Head of Medical Affairs for the Americas. “The priority review for regorafenib paves the way for us to gain regulatory approval as early as possible for the hepatocellular carcinoma patients who need it most.”

Regorafenib is currently approved for the treatment of patients with metastatic colorectal cancer who have previously been treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti­–VEGF therapy, and, if RAS wild-type, an anti–EGFR therapy, as well as the treatment of patients with locally advanced, unresectable, or metastatic gastrointestinal stromal tumor (GIST), who were previously treated with imatinib mesylate and sutinib maleate.

The sNDA is based on data from the international, multicenter, placebo-controlled phase III RESORCE trial which investigated regorafenib in patients with hepatocellular carcinoma whose disease had progressed during treatment with sorafenib.

About the RESORCE Trial

The phase III RESORCE clinical trial enrolled 573 patients whose disease had progressed during treatment with sorafenib. Patients were randomized in a 2:1 ratio to receive either regorafenib or placebo plus best supportive care.

Patients received 160 mg regorafenib once daily or placebo, for 3 weeks on/1 week off, with 28 days constituting one full treatment cycle. The primary endpoint of the study was overall survival, and secondary endpoints were time to progression, progression-free survival, objective tumor response rate, and disease control rate. Safety and tolerability were also continuously monitored.

Data presented at the European Society for Medical Oncology 18th World Congress on Gastrointestinal Cancer (Abstract LBA-03) showed that regorafenib tablets achieved a median overall survival improvement in patients with unresectable hepatocellular carcinoma that progressed after treatment with sorafenib tablets. The median overall survival was 10.6 months with regorafenib vs 7.8 months for placebo plus best supportive care. 

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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