Fort Lee, New Jersey, USA, October 14, 2026
Elevar Therapeutics has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of the combination of camrelizumab and rivoceranib as a potential first-line systemic treatment for adults with unresectable or metastatic hepatocellular carcinoma (HCC). The resubmission marks another regulatory milestone for the investigational combination, which has demonstrated encouraging survival results in a global Phase 3 clinical trial. The company submitted the application on October 9, 2026, following discussions with the FDA and its development partner, Hengrui Pharma, in response to a previously issued Complete Response Letter (CRL). The therapy has not yet received FDA approval for this indication in the United States.
Elevar Therapeutics Resubmits NDA Following FDA Feedback
The latest submission follows an FDA Complete Response Letter issued in July 2026 concerning the previous application. A CRL means that the FDA cannot approve an application in its current form and identifies issues that must be addressed before approval can be considered. According to Elevar, the company worked with the agency and Hengrui Pharma to respond to the outstanding concerns before resubmitting the application. The regulatory process is particularly important for patients with unresectable or metastatic hepatocellular carcinoma, a form of primary liver cancer that cannot be removed surgically or has spread to other parts of the body. Advanced HCC can be difficult to treat, making the development of additional first-line systemic treatment options an important area of oncology research. Elevar Therapeutics, a majority-owned subsidiary of HLB Co., Ltd., is continuing to pursue the combination as a potential option for patients who need effective treatment strategies. The resubmission does not mean the treatment has been approved. The FDA must review the application and determine whether the available evidence and regulatory requirements support marketing authorization.
Phase 3 CARES-310 Trial Shows Survival Benefits
The NDA is supported by findings from the global Phase 3 CARES-310 clinical trial, which evaluated camrelizumab in combination with rivoceranib in patients with unresectable or metastatic HCC. In the study, the combination achieved a median overall survival of 23.8 months, compared with 15.2 months for sorafenib, an established systemic treatment used in liver cancer. The reported analysis showed a hazard ratio of 0.64, with a 95% confidence interval of 0.52–0.79 and a p-value below 0.0001. These findings indicate a statistically significant reduction in the risk of death in the study population compared with sorafenib. Overall survival measures the time patients remain alive after a defined starting point, while progression-free survival assesses the time before the disease worsens or death occurs. The companies have also reported positive progression-free survival results and a manageable safety profile in the CARES-310 study. However, clinical trial findings must be considered alongside the full safety and efficacy evidence reviewed by regulators. The results do not guarantee that every patient will experience the same benefit, and treatment decisions depend on individual clinical circumstances.
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How Camrelizumab and Rivoceranib Work Together
The investigational combination brings together two medicines designed to act through different biological mechanisms. Camrelizumab is a monoclonal antibody that blocks the programmed death-1 (PD-1) immune checkpoint, a pathway that can limit the immune system’s ability to recognize and attack cancer cells. Blocking this pathway is intended to help restore antitumour immune activity. Rivoceranib is an oral vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor, designed to interfere with signalling involved in tumour blood-vessel formation. By combining immune checkpoint inhibition with anti-angiogenic activity, the treatment strategy aims to produce complementary effects against cancer. Camrelizumab was developed by Hengrui Pharma, while Elevar holds development and commercialization rights for the combination in territories outside Greater China and South Korea under its licensing arrangements. The companies are working to advance the regulatory programme and potentially expand treatment options for people with advanced liver cancer. The FDA’s review of the resubmitted application will determine the next regulatory steps. Until a decision is announced, camrelizumab plus rivoceranib remains an investigational combination for this proposed U.S. indication.
Source: Elevar Therapeutics press release
