FDA Reviews Rivoceranib, Liver Cancer Drug Developed with Hengrui

The U.S. Food and Drug Administration is currently reviewing rivoceranib, a liver cancer treatment, which is being developed in partnership with Jiangsu Hengrui Pharmaceuticals’ immunotherapy camrelizumab. This combination is being sought for market approval in the United States. The review follows previous rejections, which were tied to deficiencies identified during inspections of manufacturing facilities, though recent inspections have eased some obstacles.

The approval of rivoceranib, which showed a median overall survival of 23.8 months in a global phase 3 trial, could significantly impact the market for treatments for unresectable or metastatic hepatocellular carcinoma. The review process provides momentum for the Korean company involved in the drug’s development.