HLB Liver Cancer Drug’s FDA Substantive Review Resumes... Approval Decision Due in April Next Year

FDA Accepts Resubmission for Rivoceranib-Camrelizumab Combination Therapy
Following Cholangiocarcinoma Drug Ripikto, HLB Seeks FDA Approval for Liver Cancer Treatment

HLB’s new liver cancer drug has entered the U.S. Food and Drug Administration’s (FDA) substantive review stage. After receiving FDA approval in September for Ripikto, a new drug for cholangiocarcinoma whose active ingredient is lirafugratinib, the company is now seeking to enter the U.S. market with its liver cancer drug.

HLB announced on November 4 that its U.S. subsidiary, Elevar Therapeutics, had been notified by the FDA that it had begun a substantive review of the application for approval of a first-line treatment for hepatocellular carcinoma using a combination therapy of rivoceranib, an oral vascular endothelial growth factor receptor inhibitor, and camrelizumab, an immuno-oncology drug.

HLB corporate logo image. HLB

On October 9, Elevar resubmitted a new drug application for rivoceranib, while its Chinese partner, Hengrui Pharmaceuticals, separately resubmitted a biologics license application for camrelizumab to the FDA. The FDA will review the two applications together and decide whether to approve the combination therapy.

The FDA classified the applications as Class 2 resubmissions and set April 9, 2027, as the target date for its approval decision. Class 2 is one of the FDA’s review classifications for resubmitted applications and typically involves a six-month review period.

This is the fourth application for approval of the liver cancer drug, which previously received three FDA complete response letters. In September, HLB received FDA approval for Ripikto, a treatment for cholangiocarcinoma targeting FGFR2 gene fusions or rearrangements. Ripikto was approved for patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with these genetic alterations.

The resubmission for the liver cancer drug is based on results from CARES-310, a global Phase 3 clinical trial. The combination of rivoceranib and camrelizumab achieved a median overall survival of 23.8 months as a first-line treatment for patients with unresectable or metastatic hepatocellular carcinoma. This was significantly longer than the 15.2 months in the sorafenib group. The company said that 23.8 months was among the longest survival results reported in global Phase 3 trials of first-line treatment for liver cancer. The improvement in survival was generally consistent across various patient subgroups.

Final results from CARES-310 were published in the international journal The Lancet Oncology in December 2025. Last year, the combination of rivoceranib and camrelizumab was also included as a first-line treatment option for advanced hepatocellular carcinoma in the Barcelona Clinic Liver Cancer staging and treatment strategy and the European Society for Medical Oncology’s treatment guidelines.

Kim Donggeon, CEO of Elevar Therapeutics, said, "The CARES-310 study confirmed the potential for a meaningful improvement in survival with the combination of rivoceranib and camrelizumab as a first-line treatment for patients with unresectable hepatocellular carcinoma. Now that the substantive review has resumed, we will work closely with Hengrui Pharmaceuticals and do everything possible to support the FDA review."

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