HLB resubmits FDA application for liver cancer treatment
Summary
HLB resubmitted its application to the U.S. Food and Drug Administration for rivoceranib combined with camrelizumab as a first-line treatment for liver cancer. HLB’s U.S. subsidiary Elevar Therapeutics and Chinese partner Hengrui Pharma filed the application after completing manufacturing-facility inspections and addressing concerns in an FDA complete response letter issued in July. The CARES-310 Phase 3 trial showed median overall survival of 23.8 months, compared with 15.2 months for sorafenib. The FDA’s review remains pending.
Key Facts
- The resubmission was filed on Friday by Elevar Therapeutics and Hengrui Pharma.
- The CARES-310 global Phase 3 trial enrolled patients with unresectable or metastatic liver cancer.
- The combination reduced the risk of death by 36 percent compared with sorafenib in the trial’s final analysis.
- The findings were published in The Lancet Oncology in December 2025.
- The treatment was included as a first-line option in the 2025 Barcelona Clinic Liver Cancer treatment strategy and European Society for Medical Oncology guidelines despite lacking regulatory approval.
Drugmaker HLB's corpoarate logo / Courtesy of HLB
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 achieved median overall survival of 23.8 months, compared with 15.2 months for sorafenib, the control treatment, representing a 36 percent reduction in the risk of death.
The findings, published in The Lancet Oncology in December 2025, also showed consistent treatment effects across various patient subgroups, according to HLB.
The company said the combination has been included as a first-line treatment option in the 2025 Barcelona Clinic Liver Cancer treatment strategy and European Society for Medical Oncology guidelines, despite not yet receiving regulatory approval.
Elevar Therapeutics said patients with unresectable liver cancer continue to face significant unmet medical needs and that the company would work closely with the FDA to complete the review.
The resubmission marks another step in HLB’s effort to secure U.S. approval for the combination therapy, with the FDA’s review outcome still pending.
This article was published with the assistance of generative AI and edited by The Korea Times.
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