HLB has resubmitted its application for approval of a liver cancer drug in the United States about three months after receiving a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA).
HLB said on the 12th that its U.S. subsidiary, Elevar Therapeutics, and Chinese partner Hengrui Pharmaceuticals submitted a new drug application/biologics license application (NDA/BLA) to the FDA on the 9th for approval of the combination of rivoceranib and camrelizumab as a first-line treatment for liver cancer.
In July, the FDA issued a CRL for the NDA Elevar had submitted in January. Elevar and Hengrui subsequently consulted with the FDA, addressed the issues raised in the letter and completed the resubmission.
A CRL is a document issued when the FDA determines that the submitted data are insufficient to approve a drug and identifies matters that require further attention.
The application is based on the global Phase 3 CARES-310 trial. In the final analysis, the combination of rivoceranib and camrelizumab achieved a median overall survival (mOS) of 23.8 months in patients with unresectable or metastatic liver cancer. It reduced the risk of death by 36% compared with the control group receiving sorafenib, whose median overall survival was 15.2 months.
This represents one of the longest survival outcomes reported to date in clinical trials of first-line liver cancer treatments. Consistent treatment benefits were also observed across various patient subgroups.
The final CARES-310 results were published in the international medical journal The Lancet Oncology in December last year. Despite not yet having received regulatory approval, the combination of rivoceranib and camrelizumab has been recognized for its clinical value and was included as a first-line liver cancer treatment option in the 2025 Barcelona Clinic Liver Cancer (BCLC) treatment strategy and European Society for Medical Oncology (ESMO) guidelines.
“Unresectable liver cancer remains an area of significant unmet medical need, and Elevar has continued working to provide patients and physicians with a new treatment option,” said Kim Dong-gun, CEO of Elevar Therapeutics. “We will work closely with the FDA to ensure the review of this application is completed successfully.”