Priority review status has been granted by the FDA for the supplemental New Drug Application (sNDA) for regorafenib tablets for the second-line systemic treatment of patients with hepatocellular carcinoma (HCC).
HCC is the most common form of liver cancer, a disease that affects nearly 40,000 patients in the U.S. and is the second deadliest form of cancer worldwide.
The FDA grants priority review to medicines that, if approved, would provide significant improvements in the safety or effectiveness of the treatment for serious conditions. Under the Prescription Drug User Fee Act, the FDA aims to complete its review within 6 months (compared to 10 months under standard review).
The sNDA is based on data from the international, multicenter, placebo-controlled phase III RESORCE trial that investigated regorafenib in patients with HCC whose disease had progressed during treatment with sorafenib.
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. Regorafenib is also used for the treatment of patients with locally advanced, unresectable, or metastatic gastrointestinal stromal tumor who were previously treated with imatinib mesylate and sutinib malate