HLB liver cancer drug enters FDA review, decision expected by April

Korean biopharmaceutical group HLB is getting a second shot at U.S. Food and Drug Administration (FDA) approval for its flagship liver cancer therapy.

The FDA has officially accepted a resubmitted application from HLB’s California-based drug development arm, Elevar Therapeutics, to evaluate a combination treatment for advanced liver cancer, setting a target decision date of April 9.

Elevar said the FDA had accepted for substantive review its resubmitted new drug application for rivoceranib, an oral VEGF-targeting tyrosine kinase inhibitor, combined with camrelizumab, an anti-PD-1 antibody, as a first-line treatment for hepatocellular carcinoma.

The FDA classified the application as a Class 2 resubmission, setting April 9 as its target decision date under the Prescription Drug User Fee Act.

The review covers two applications submitted separately by Elevar and China’s Hengrui Pharma, which resubmitted the biologics license application for camrelizumab.

The FDA plans to review the applications together to determine whether the combination therapy can be approved.

The resubmissions are supported by results from the global Phase 3 CARES-310 trial, which evaluated the combination in patients with unresectable or metastatic hepatocellular carcinoma, the most common form of liver cancer.

The treatment produced a median overall survival of 23.8 months, compared with 15.2 months for sorafenib, representing a statistically significant improvement, according to the company.

The survival benefit was reflected in a hazard ratio of 0.64, with a 95 percent confidence interval of 0.52 to 0.79 and a P value below 0.0001.

Final results from CARES-310 were published in The Lancet Oncology in December 2025.

The combination was also included in 2025 treatment recommendations from the Barcelona Clinic Liver Cancer strategy and European Society for Medical Oncology guidelines for advanced hepatocellular carcinoma.

“Through the CARES-310 study, we confirmed the potential of rivoceranib and camrelizumab combination therapy to meaningfully improve overall survival in first-line treatment for patients with unresectable hepatocellular carcinoma,” said Kim Dong-gun, chief executive of Elevar Therapeutics.

“With the substantive review now underway, we will work closely with Hengrui Pharma to ensure thorough cooperation throughout the FDA review process.”

This article was published with the assistance of generative AI and edited by The Korea Times.