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 a common and often fatal liver cancer, especially for people with cirrhosis. Rivoceranib and camrelizumab are a two-drug combination that blocks the tumor's blood supply and removes a biological brake on the immune system. This dual attack may help the body fight the cancer more effectively.
A Trial to Evaluate the Efficacy and Safety of Camrelizumab Plus Rivoceranib (Apatinib) Versus Active Surveillance as Adjuvant Therapy in Patients with Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation.
Source: ClinicalTrials.gov