FDA Begins Review of Liver Cancer Combination Therapy
The U.S. regulator has started its main review of HLB's Rivoceranib-Camrelizumab combination for first-line hepatocellular carcinoma.
Updated on Nov. 4, 2026 in Cancer
The FDA has begun its main review of HLB's resubmitted new drug application for Rivoceranib combined with Hengrui Pharmaceutical's Camrelizumab for first-line hepatocellular carcinoma. The agency has set a target action date of April 9, 2027.
Why it matters
The combination therapy was previously delayed by supplementary requirements, so the review timeline sets when patients could gain access to a new first-line option for this cancer. The FDA plans to review the Rivoceranib and Camrelizumab applications together.
The CARES-310 Phase 3 trial enrolled 543 patients across 95 medical institutions in 13 countries and regions, showing median overall survival of 23.8 months for the combination versus 15.2 months for sorafenib. Whether the FDA will request further data beyond the existing submission remains unresolved.
The players
HLB
A South Korean pharmaceutical company whose U.S. subsidiary Elevar Therapeutics submitted the Rivoceranib application.
Hengrui Pharmaceutical
A Chinese pharmaceutical company that developed Camrelizumab and submitted its Biologics License Application.
U.S. Food and Drug Administration
The federal agency responsible for reviewing and approving drugs and biologics for sale in the United States.
The details
Elevar Therapeutics, HLB's U.S. subsidiary, resubmitted the Rivoceranib application on September 9, and Hengrui Pharmaceutical submitted a BLA for Camrelizumab. HLB and Hengrui plan to jointly respond to any additional FDA data requests during the review.
Timeline
September 9: Elevar resubmitted the Rivoceranib NDA.
November 4, 2026: HLB announced the FDA main review had begun.
April 9, 2027: FDA target action date for the combination therapy.
Health Landscape
The FDA's Class 2 resubmission pathway, which typically grants a six-month review period, governs this application after earlier supplementary requirements delayed approval. The review places the combination within the ongoing push to expand first-line immunotherapy options for advanced liver cancer.
If approved, the combination would give patients with unresectable or metastatic hepatocellular carcinoma a first-line option that extended median overall survival by 8.6 months in the trial. Patients and clinicians should watch for the FDA's decision on the April 2027 target date to learn when the therapy may become available.
The takeaway
The combination therapy's trial data show a meaningful survival benefit over sorafenib, but patients should await the FDA's final decision before expecting access. Staying informed through oncologists and official FDA announcements will help track the April 2027 timeline.
What happens next
The FDA is scheduled to reach its target action date on April 9, 2027, when it is expected to decide on the combination therapy.
Further reading
Explore more on Cancer treatments and drug approvals.
Source note: This article includes information reported by 조선일보.
