Elevar Resubmits NDA for Camrelizumab and Rivoceranib Combination Therapy

FORT LEE, N.J., Oct. 14, 2026 /CourierPR/ -- Elevar Therapeutics, a biopharmaceutical company based in Fort Lee, New Jersey, has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for a combination therapy involving camrelizumab and rivoceranib. This therapy is intended as a first-line treatment option for unresectable or metastatic hepatocellular carcinoma (uHCC).

The resubmission follows a Complete Response Letter (CRL) issued by the FDA in July 2026, which Elevar addressed by working closely with the agency and its partner, Hengrui Pharma. The NDA was resubmitted on October 9, 2026, and is based on the global Phase 3 CARES-310 study. This study demonstrated a median overall survival (mOS) of 23.8 months for patients receiving the camrelizumab and rivoceranib combination, compared to 15.2 months for those treated with sorafenib, a standard therapy for uHCC. The hazard ratio (HR) for the combination therapy was 0.64, with a 95% confidence interval of 0.52 to 0.79, and a p-value less than 0.0001. These results indicate a significant improvement in overall survival and progression-free survival, with the safety profile of the combination regimen being manageable.

The CARES-310 study's positive outcomes were published in The Lancet Oncology in December 2025, highlighting the clinical relevance of the treatment. Prior to regulatory approval, the combination regimen was included as a first-line treatment option for advanced HCC in the 2025 Barcelona Clinic Liver Cancer treatment strategy and European Society for Medical Oncology guidelines. This recognition underscores the importance of the therapy in addressing the unmet medical need for uHCC.

Hepatocellular carcinoma, the most common type of liver cancer, typically develops in people with chronic liver inflammation, often due to viral or non-viral causes. With a poor prognosis and limited treatment options, HCC remains a significant health challenge. More than 800,000 people are diagnosed with liver cancer worldwide each year, and it is a leading cause of cancer deaths, accounting for over 700,000 annually, according to the American Cancer Society.

Rivoceranib, an oral small-molecule tyrosine kinase inhibitor (TKI), is a highly selective inhibitor of vascular endothelial growth factor receptors (VEGFRs). This inhibition is a clinically validated target for limiting tumor growth and disease progression. Rivoceranib has been studied in various solid tumor indications, including uHCC, gastric cancer, adenoid cystic carcinoma, and colorectal cancer. The drug has been well tolerated in clinical trials, with a safety profile comparable to other TKIs and VEGF inhibitors. Orphan drug designations have been granted for gastric cancer (U.S., EU, and South Korea), adenoid cystic carcinoma (U.S.), and uHCC (U.S. and EU).

Camrelizumab, a humanized monoclonal antibody that binds to the programmed death-1 (PD-1) receptor, is currently approved for 10 indications in China, including lung cancer, liver cancer, esophageal cancer, nasopharyngeal cancer, and cervical cancer. The U.S. Food and Drug Administration granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021, and the European Medicines Agency (EMA) did so in August 2024. In October 2023, Elevar licensed camrelizumab in combination with rivoceranib for HCC for commercialization worldwide, excluding Greater China and South Korea.