FDA Accepts NDA Resubmission for Rivoceranib/Camrelizumab Combo in Unresectable HCC

Key Insights

• The FDA has accepted the resubmission of the NDA for rivoceranib plus camrelizumab as a first-line treatment for unresectable or metastatic hepatocellular carcinoma.
• The application is based on data from the phase 3 CARES-310 trial, with a target action date set for March 20, 2025, under the Prescription Drug User Fee Act.
• The initial NDA received a complete response letter in May 2024 due to manufacturing deficiencies and incomplete bioresearch monitoring clinical inspections.

The FDA has accepted the resubmission of a new drug application (NDA) for the combination of rivoceranib and camrelizumab as a first-line treatment for patients with unresectable or metastatic hepatocellular carcinoma (HCC). This decision follows a previous complete response letter issued in May 2024, which cited manufacturing deficiencies and incomplete bioresearch monitoring clinical inspections.

The NDA is based on data from the phase 3 CARES-310 trial, which evaluated the efficacy and safety of rivoceranib in combination with camrelizumab in patients with unresectable HCC. The Prescription Drug User Fee Act (PDUFA) has assigned a target action date of March 20, 2025, for the current application.

Hepatocellular carcinoma is a significant global health burden, with limited treatment options for patients with advanced disease. The combination of rivoceranib and camrelizumab represents a potential new therapeutic approach, offering hope for improved outcomes in this patient population. Rivoceranib is an anti-angiogenic tyrosine kinase inhibitor, while camrelizumab is a PD-1 inhibitor that enhances the immune response against cancer cells. The combination of these two agents may provide synergistic effects, leading to better tumor control and survival benefits.

The CARES-310 trial is a randomized, open-label, multi-center phase 3 study that enrolled patients with unresectable HCC who had not received prior systemic therapy. Patients were randomized to receive either rivoceranib plus camrelizumab or sorafenib. The primary endpoint of the study was overall survival (OS), and secondary endpoints included progression-free survival (PFS), objective response rate (ORR), and safety. Detailed results from the CARES-310 trial are expected to be presented at an upcoming medical conference.

The FDA's acceptance of the NDA resubmission marks an important step forward in the development of this combination therapy for HCC. If approved, rivoceranib plus camrelizumab could provide a valuable new treatment option for patients with this challenging disease.