HLB Reapplies for FDA Approval of First-Line Liver Cancer Treatment
HLB has moved to reapply to the U.S. Food and Drug Administration (FDA) for approval of its novel liver cancer drug.
According to HLB on Oct. 12, its U.S. subsidiary Elevar Therapeutics and its partner, China’s Hengrui Pharmaceuticals, submitted an application for approval of rivoceranib and camrelizumab as a first-line treatment for liver cancer on Oct. 9 local time (NDA/BLA).
The application is based on the global Phase 3 trial, CARES-310. 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 15.2 months recorded for the control group treated with sorafenib (HR=0.64, 95% CI 0.52~0.79, P<0.0001). This represents one of the longest survival durations reported to date in clinical trials of first-line treatments for liver cancer. Consistent treatment benefits were also observed across various patient subgroups.
The final CARES-310 analysis was published last December in the international journal The Lancet Oncology. Despite not yet having received regulatory approval, the combination of rivoceranib and camrelizumab was recognized for its clinical value and included as a first-line liver cancer treatment option in the 2025 Barcelona Clinic Liver Cancer (BCLC) treatment strategy and the European Society for Medical Oncology (ESMO) guidelines.
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“Unresectable liver cancer remains an area of high unmet medical need, and Elevar has continued its efforts to provide patients and healthcare professionals with new treatment options,” said Kim Dong-gun, CEO of Elevar Therapeutics. “Now that the manufacturing facility inspection process has been completed, we will work closely with the FDA to ensure the review of this application is successfully completed, based on the clinical value demonstrated in CARES-310.”
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