Elevar Therapeutics receives FDA CRL for rivoceranib-camrelizumab in HCC
Elevar Therapeutics has received a complete response letter (CRL) from the US Food and Drug Administration for its new drug application covering the combination of rivoceranib and camrelizumab as a first-line treatment for unresectable or metastatic hepatocellular carcinoma (HCC). The agency identified deficiencies arising from a current good manufacturing practice (cGMP) inspection of a manufacturing site listed on the rivoceranib application, rather than any concern with the underlying clinical evidence.
The distinction matters commercially. The FDA has previously acknowledged the strength of the clinical package, and the company says it continues to believe in that data. The CRL therefore represents a regulatory manufacturing hurdle rather than a scientific rejection, a categorically different setback from a refusal-to-file or a clinical deficiency letter.
The clinical case
The NDA was anchored to the global Phase 3 CARES-310 study, in which patients with unresectable or metastatic HCC receiving the combination achieved a median overall survival of 23.8 months. Elevar has described this as the longest overall survival reported to date among first-line systemic treatments in the indication. The final analysis was published in The Lancet Oncology in December 2025, and the regimen was incorporated into both the 2025 Barcelona Clinic Liver Cancer treatment strategy and European Society for Medical Oncology guidelines ahead of any US approval.
Dong-Gun Kim, chief executive of Elevar Therapeutics, said the company would engage with the FDA promptly to understand the agency's feedback and determine the most effective path forward, adding that it remains committed to patients with HCC. The company has not disclosed the specific nature of the manufacturing deficiencies or indicated how long remediation might take.
Regulatory and competitive context
Manufacturing-related CRLs are resolvable but can take time. Depending on whether the FDA requires a re-inspection of the flagged site, a response could take anywhere from several months to over a year. Investors will watch closely for any indication that Elevar can submit a complete response quickly.
The first-line HCC space is crowded. Atezolizumab plus bevacizumab received FDA approval in 2020 and remains a standard of care, while the combination of tremelimumab and durvalumab gained approval in 2022. Lenvatinib and sorafenib retain a role for patients ineligible for immunotherapy-based regimens. A median overall survival approaching 24 months, if confirmed in the US label, would position rivoceranib plus camrelizumab competitively, but delayed approval extends the window for entrenched regimens to consolidate market share.
Rivoceranib, a VEGFR-targeting small-molecule TKI, and camrelizumab, an anti-PD-1 monoclonal antibody developed by Hengrui Pharma, are already approved in China as a first-line HCC combination. Elevar holds global rights to rivoceranib outside China and licensed camrelizumab for commercialisation outside Greater China and Korea in October 2023. Both agents carry orphan drug designations in HCC in the US and EU, which may provide some commercial protection once approval is secured.
HCC remains a high-burden indication. The American Cancer Society estimates more than 800,000 new liver cancer diagnoses globally each year, with the disease accounting for over 700,000 deaths annually. First-line systemic therapy options, while expanding, remain limited for the substantial proportion of patients who present with advanced or unresectable disease.