FORT LEE, N.J., July 10, 2026
Elevar Therapeutics announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the company’s New Drug Application (NDA) seeking approval of the combination of rivoceranib and camrelizumab as a first-line treatment for patients with unresectable or metastatic hepatocellular carcinoma (HCC). According to the company, the FDA’s decision was not based on the clinical efficacy or safety data, but rather on deficiencies identified during a current Good Manufacturing Practice (cGMP) inspection at a manufacturing facility associated with the rivoceranib NDA. Elevar stated that it is reviewing the agency’s comments and plans to work closely with the FDA to determine the most appropriate regulatory pathway toward potential approval while reaffirming its commitment to delivering new treatment options for patients with advanced liver cancer.
Phase 3 CARES-310 Trial Demonstrated Record Overall Survival
Elevar Therapeutics emphasized that the FDA has previously acknowledged the strength of the clinical evidence supporting the application. The NDA was primarily supported by results from the global Phase 3 CARES-310 clinical trial, in which the combination of rivoceranib, an oral vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor, and camrelizumab, an anti-PD-1 monoclonal antibody, achieved a median overall survival of 23.8 months in patients with unresectable or metastatic HCC. The company noted that this represents the longest overall survival reported among first-line therapies for advanced hepatocellular carcinoma to date. The study also demonstrated consistent efficacy across multiple patient subgroups with a manageable safety profile, and its final analysis was published in The Lancet Oncology in December 2025. Before the FDA review concluded, the treatment combination had already been incorporated into the 2025 Barcelona Clinic Liver Cancer (BCLC) treatment strategy and the European Society for Medical Oncology (ESMO) guidelines, reflecting broad clinical recognition of its therapeutic value.
Company Plans Regulatory Discussions Following FDA Feedback
Following receipt of the Complete Response Letter, Elevar Therapeutics stated that it will engage with the FDA to fully understand the manufacturing observations and define the corrective actions required to support a future resubmission. Chief Executive Officer Dong-Gun Kim said the company remains confident in the clinical evidence supporting the rivoceranib and camrelizumab combination despite the regulatory setback. The company stressed that it remains committed to patients with hepatocellular carcinoma and intends to pursue every opportunity to bring the therapy to market. The regulatory delay centers on manufacturing compliance rather than the treatment’s demonstrated clinical performance, preserving confidence in the underlying efficacy data generated by the Phase 3 program.
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Rivoceranib and Camrelizumab Continue Global Development in Oncology
Rivoceranib has been evaluated in more than 6,000 patients worldwide and continues to be investigated both as a monotherapy and in combination with chemotherapy and immunotherapy across multiple solid tumors. The therapy has received Orphan Drug Designation in several oncology indications, including hepatocellular carcinoma, while camrelizumab has been studied in more than 5,000 patients and is currently approved for multiple cancer indications in China. The combination is already approved in China as a first-line treatment for unresectable hepatocellular carcinoma, providing real-world clinical experience outside the United States. By addressing the manufacturing issues identified by the FDA while leveraging the strong clinical evidence from the CARES-310 study, Elevar Therapeutics aims to advance the regulatory review process and continue developing a treatment that has the potential to improve outcomes for patients facing one of the world’s deadliest forms of liver cancer.
Source: Elevar Therapeutics press release
