Elevar resubmits NDA for camrelizumab plus rivoceranib in HCC
Elevar Therapeutics has resubmitted a New Drug Application to the FDA for the combination of rivoceranib, an oral VEGF receptor tyrosine kinase inhibitor, and camrelizumab, an anti-PD-1 monoclonal antibody, as a first-line treatment for unresectable or metastatic hepatocellular carcinoma. The resubmission, filed on 9 October 2026, responds to a Complete Response Letter the agency issued in July 2026 following an earlier NDA submitted in January of this year.
The application is underpinned by data from the global Phase 3 CARES-310 study, in which the combination produced a median overall survival of 23.8 months against 15.2 months for sorafenib, the standard comparator, yielding a hazard ratio of 0.64 (95% CI 0.52–0.79, P less than 0.0001). Results were broadly consistent across patient subgroups, according to the company. The final analysis was published in The Lancet Oncology in December 2025, and the regimen was incorporated into the 2025 Barcelona Clinic Liver Cancer treatment guidelines and European Society for Medical Oncology recommendations ahead of US regulatory approval.
The regulatory path
Chief executive Dong-Gun Kim said the Elevar team had remained "steadfast" in its commitment to bring the combination to patients, describing unresectable HCC as "an area of significant unmet medical need." The NDA was prepared in collaboration with Hengrui Pharma, the Chinese licence-holder for both assets and the originator of camrelizumab. Elevar holds global rights to rivoceranib outside China, and licensed the camrelizumab combination rights for commercialisation outside Greater China and South Korea from Hengrui in October 2023.
The CRL issued in July did not specify a clinical deficiency; Elevar's statement indicates the agency's concerns were addressed through additional documentation rather than new trial data. Under FDA review timelines, a Class 2 resubmission typically carries a six-month review clock, which would place a potential action date in April 2027. The agency has not publicly confirmed the classification.
Market context
The first-line systemic HCC space has grown considerably more competitive since atezolizumab plus bevacizumab received FDA approval in 2020, establishing an IO-VEGF combination standard. Tremelimumab plus durvalumab subsequently gained approval in 2022 on overall survival data in a broader patient population. Rivoceranib plus camrelizumab would enter a market that already has two approved combination regimens, meaning commercial differentiation will depend heavily on the final label, pricing strategy and any subgroup advantages Elevar can demonstrate.
Hepatocellular carcinoma is the most common form of liver cancer and accounts for more than 700,000 deaths annually worldwide, according to the American Cancer Society. The majority of cases arise in the context of chronic liver disease, and most patients present at an advanced or unresectable stage, making effective first-line options a persistent clinical priority. Rivoceranib is already approved in China under the name apatinib in gastric cancer, and the combination with camrelizumab received Chinese approval for HCC in January 2023, giving Elevar a body of post-marketing safety data that may support its regulatory submission in the US.