Elevar Therapeutics has achieved a significant regulatory milestone with the US Food and Drug Administration’s acceptance of a resubmitted New Drug Application for rivoceranib in combination with camrelizumab as first-line systemic treatment for unresectable or metastatic hepatocellular carcinoma (uHCC). As reported by Drugs.com, the FDA has assigned a Prescription Drug User Fee Act target action date of July 23, 2026, positioning this innovative combination therapy for potential approval within the coming months.
Addressing a Critical Medical Need
Hepatocellular carcinoma represents the most prevalent liver cancer type, with staggering global impact: more than 800,000 people annually receive HCC diagnoses, and the disease accounts for over 700,000 cancer deaths yearly according to the American Cancer Society. The disease typically develops in patients with chronic liver inflammation from viral or non-viral causes and carries a historically poor prognosis with limited therapeutic options, creating an urgent, ongoing medical need.
The resubmission addresses concerns previously raised by the FDA in a Complete Response Letter issued in March 2025. Elevar’s resubmitted NDA, coupled with Hengrui Pharma’s parallel biologics license application for camrelizumab, will undergo an integrated FDA review process, recognizing the two agents’ complementary mechanisms forming a unified therapeutic regimen.
Clinical Excellence and Precedent-Setting Outcomes
The regulatory advancement is grounded in compelling clinical evidence from the global Phase 3 CARES-310 study, demonstrating the camrelizumab-rivoceranib combination achieved a median overall survival of 23.8 months in uHCC patients, representing the longest overall survival reported to date among first-line HCC treatments. This remarkable efficacy extends consistently across multiple patient subgroups while maintaining a manageable safety profile.
The trial’s final analysis was published in December 2025 in The Lancet Oncology, a leading international medical journal, providing robust peer-reviewed validation of the combination’s clinical value. Notably, the medical and oncologic community has already formally recognized this combination’s significance: prior to regulatory approval, the camrelizumab-rivoceranib regimen was incorporated into the 2025 Barcelona Clinic Liver Cancer treatment strategy and European Society for Medical Oncology guidelines as a first-line uHCC treatment option.
Understanding the Therapeutic Mechanisms
Rivoceranib functions as a small-molecule tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor, inhibiting tumor angiogenesis—a clinically validated mechanism limiting tumor growth and disease progression. The agent has demonstrated extensive clinical experience, studied in over 6,000 patients worldwide with a well-tolerated safety profile comparable to other VEGF inhibitors and tyrosine kinase inhibitors.
Camrelizumab, a humanized monoclonal antibody targeting programmed death-1, harnesses immunotherapy’s proven effectiveness across diverse malignancies through PD-1/PD-L1 pathway blockade. The agent has been evaluated in over 5,000 patients across 50 ongoing clinical trials spanning multiple tumor types and treatment settings.
Global Recognition and Regulatory Journey
Elevar holds global rights to rivoceranib (excluding China), while the combination was previously approved in China in January 2023. Both agents have received orphan drug designations for various indications, highlighting their significance for treating otherwise underserved patient populations.
Chief Executive Officer Dong-Gun Kim emphasized Elevar’s commitment to FDA collaboration and manufacturing facility readiness, reflecting the company’s strategic focus on achieving successful regulatory approval and ultimately delivering this promising therapeutic option to patients with unresectable hepatocellular carcinoma who currently face limited treatment alternatives
