Bayer announced that the U.S. Food and Drug Administration (FDA) has granted priority review status for the supplemental new drug application (sNDA) for Stivarga (regorafenib) tablets for the second-line systemic treatment of patients with hepatocellular carcinoma (HCC) in the U.S. 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 (PDUFA), the FDA aims to complete its review within six months (compared to 10 months under standard review). Stivarga is currently approved for the treatment of patients with metastatic colorectal cancer (mCRC) 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 Stivarga in patients with HCC whose disease had progressed during treatment with Nexavar.