HLB resubmits FDA application for liver cancer treatment

Korean drugmaker HLB has resubmitted its application for U.S. approval of a combination therapy for advanced liver cancer, renewing its push to bring the target treatment to market after addressing regulatory concerns raised earlier this year. The Korean biopharmaceutical company said Monday that its U.S. subsidiary, Elevar Therapeutics, and Chinese partner Hengrui Pharma submitted the application to the U.S. Food and Drug Administration (FDA) on Friday, seeking approval of rivoceranib in combination with camrelizumab as a first-line treatment for liver cancer. The resubmission follows an FDA complete response letter issued in July regarding an application Elevar filed in January, prompting the companies to work with regulators to address the agency’s concerns. HLB said inspections of the manufacturing facilities have recently been completed, allowing the companies to submit the application again. The filing is based on CARES-310, a global Phase 3 clinical trial involving patients with unresectable or metastatic liver cancer. In the trial’s final analysis, the combination treatment ac