HLB Completes FDA Resubmission for First-Line Liver Cancer Treatment

Manufacturing facility inspection completed; FDA application resubmitted
For patients with unresectable or metastatic liver cancer
Median overall survival of 23.8 months in clinical trial

HLB has completed the resubmission of its application for U.S. Food and Drug Administration (FDA) approval of a first-line liver cancer treatment.

HLB said on Oct. 12 that its U.S. subsidiary Elevar Therapeutics and Chinese partner Hengrui Pharmaceuticals submitted applications to the FDA on Oct. 9 (local time) for the combination therapy of rivoceranib and camrelizumab. Elevar submitted a New Drug Application (NDA), while Hengrui Pharmaceuticals submitted a Biologics License Application (BLA).

HLB corporate logo image. HLB

In July this year, the FDA issued a Complete Response Letter (CRL) regarding an application Elevar had submitted in January. Elevar and Hengrui Pharmaceuticals consulted with the FDA and addressed the requested deficiencies before completing the resubmission.

The application is supported by a global Phase 3 clinical trial. According to HLB, the final analysis found that median overall survival was 23.8 months in the group receiving the rivoceranib-camrelizumab combination, longer than the 15.2 months in the control group receiving sorafenib. The risk of death was 36% lower in the combination therapy group. The company said this was the longest survival reported to date among clinical trial results for first-line liver cancer treatments. Consistent treatment effects were also confirmed across various patient subgroups.

The final clinical trial analysis was published in the international journal The Lancet Oncology in December last year. Last year, the combination therapy was presented as a first-line liver cancer treatment option in the Barcelona Clinic Liver Cancer treatment strategy and the European Society for Medical Oncology's clinical practice guidelines.

Kim Dong-geon, CEO of Elevar Therapeutics, said, "Unresectable liver cancer remains an area with significant unmet medical needs, and Elevar has worked to provide patients and healthcare professionals with a new treatment option. Now that the manufacturing facility inspection process has been completed, we will work closely with the FDA to ensure a successful review, building on the treatment efficacy demonstrated in clinical trials."

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