for unresectable hepatocellular carcinoma
FDA issued a second-cycle Complete Response Letter for the rivoceranib + camrelizumab combination in unresectable/metastatic hepatocellular carcinoma on July 10, 2026 — 13 days ahead of the July 23 PDUFA target. CRL cited deficiencies identified during a cGMP inspection of a manufacturing site listed on the Rivoceranib NDA (same class of findings as the 2024 first-cycle CRL).
Hepatocellular carcinoma is the most common form of primary liver cancer in adults and a leading cause of death in people with cirrhosis. Rivoceranib blocks proteins that help liver tumors grow new blood vessels, while camrelizumab is an antibody that helps the immune system recognize and attack cancer cells. Together they may slow tumor growth in liver cancer that cannot be surgically removed, though the combination's benefit is still being reviewed.
A study to evaluate efficacy and safety of transarterial chemoembolization (TACE) in combination with Camrelizumab and Rivoceranib (Apatinib) therapy in patients with incurable hepatocellular carcinoma.
Source: ClinicalTrials.gov