Elevar Therapeutics announced its plans to resubmit its application to the FDA for rivoceranib in combination with camrelizumab as a first-line treatment for unresectable hepatocellular carcinoma (uHCC).
The follows a Type A meeting with the FDA on July 2, 2024, where the agency confirmed that the resubmission can proceed without delay and that additional GMP and Bioresearch Monitoring (BIMO) inspections may occur post-resubmission.
The original NDA, submitted in May 2023, was met with a complete response letter citing GMP deficiencies at China-based partner Jiangsu Hengrui Pharma's facility and incomplete BIMO clinical inspections due to FDA travel restrictions. There were no issues related to clinical data or the rivoceranib manufacturing site.
Elevar intends to resubmit the NDA promptly, including data from the CARES-310 study, which showed a median overall survival of 23.8 months for patients with uHCC.
