Bayer has started off the new year with another approval from theU.S. Food and Drug Administration (FDA). This time, the FDA has granted priority review designation to the supplemental New Drug Application (sNDA) for regorafenib for the second-line treatment of patients with unresectable hepatocellular carcinoma (uHCC) in the U.S.
Bayer’s Executive Committee member, Dr. Joerg Moeller, sees Nexavar as an important step for HCC treatment. He welcomed the priority review for regorafenib and said that 30,000 patients that are yearly being diagnosed with liver cancer in the U.S. will now have effective second-line treatment options.
The FDA grants priority review to medicines that if approved, would be 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).
Regorafenib is already approved under the brand name Stivarga in many countries, including the U.S., to treat metastatic colorectal cancer and unresectable and/or metastatic gastrointestinal stromal tumors.