The Food and Drug Administration has again rejected the approval request for Hengrui Pharma and Elevar Therapeutics’ oncology drug combination due to manufacturing issues, according to a July 15 statement. This marks the third rejection for the companies' combination of rivoceranib, an oral tyrosine kinase inhibitor, and camrelizumab, an anti-PD-1 antibody.
Hengrui and Elevar are developing this combination as a treatment for unresectable or metastatic hepatocellular carcinoma. A Phase 3 trial previously linked first-line use of the drugs to longer overall survival compared to sorafenib. However, repeated manufacturing deficiencies have delayed market entry.
In 2024, the FDA rejected camrelizumab after identifying deficiencies during a preapproval inspection at one of its production plants. The agency was also unable to complete clinical inspections that year due to travel restrictions, which contributed to issuing a complete response letter for rivoceranib. In 2025, another rejection followed after similar findings during a reinspection of the camrelizumab plant.
The most recent setback involved reversed roles: deficiencies were found at a rivoceranib production facility during an FDA inspection. The agency issued a Form 483 outlining these problems and requested satisfactory responses from the facility team before resubmission can occur. Approval will require confirmation that current good manufacturing practices are met; this may involve further inspections before any future clearance is granted.
Elevar CEO Dong-Gun Kim said in a statement that Elevar is reviewing the FDA’s latest complete response letter and plans "to work closely with the agency to find the right path forward." Kim added that Elevar remains committed to advancing both rivoceranib and camrelizumab, and "will engage with the FDA promptly."
