As reported by The Manila Times, the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Elevar Therapeutics regarding its new drug application for the combination of rivoceranib and camrelizumab as an initial systemic treatment for patients with unresectable or metastatic hepatocellular carcinoma (HCC).
According to the company, the FDA’s decision was not based on concerns about the therapy’s clinical efficacy or safety data. Instead, the agency cited deficiencies identified during a current Good Manufacturing Practice (cGMP) inspection at a manufacturing facility included in the rivoceranib application.
Elevar stated that it is reviewing the FDA’s feedback and plans to work closely with the agency to address the issues and determine the next regulatory steps. Company leadership emphasized its continued commitment to developing the rivoceranib-camrelizumab regimen for patients with advanced liver cancer.
The application was supported by results from the global Phase 3 CARES-310 trial, which evaluated the combination in patients with advanced HCC who had not previously received systemic treatment. Trial data demonstrated a median overall survival of 23.8 months, a figure that Elevar described as the longest overall survival reported in a Phase 3 study of a first-line treatment for advanced HCC. The treatment also showed consistent benefits across multiple patient populations while maintaining a manageable safety profile.
Final results from CARES-310 were published in The Lancet Oncology in December 2025, further strengthening the evidence base for the regimen. The company noted that the FDA had previously recognized the substantial clinical data supporting the application.
Beyond the regulatory review process, the rivoceranib-camrelizumab combination has already gained recognition within the oncology community. Before receiving FDA approval, the regimen was incorporated into the 2025 Barcelona Clinic Liver Cancer (BCLC) treatment strategy and the European Society for Medical Oncology (ESMO) clinical practice guidelines as a first-line treatment option for advanced HCC.
Hepatocellular carcinoma is the most common form of primary liver cancer and remains a major cause of cancer-related mortality worldwide. The FDA’s CRL represents a regulatory setback for the combination therapy in the United States, although Elevar maintains that the underlying clinical evidence remains strong and intends to pursue a path forward with the agency.
If the manufacturing-related concerns can be satisfactorily resolved, the company may be able to resubmit the application and continue seeking approval for a treatment that has shown promising survival outcomes in patients with advanced liver cancer.
