Elevar Therapeutics Gears Up For FDA Nod In Liver Cancer Treatment

Elevar Therapeutics, Inc. (Elevar), a subsidiary of HLB Co., Ltd., announced today its intention to resubmit the NDA for rivoceranib combined with camrelizumab as a primary treatment for Unresectable Hepatocellular Carcinoma (uHCC). This follows a successful Type A meeting with the FDA on July 2, initiated by Jiangsu Hengrui Pharmaceuticals (Hengrui Pharma) to address concerns raised in the FDA's May 16 Complete Response Letters (CRLs) to both Hengrui Pharma and Elevar. Elevar originally submitted the NDA in May 2023.

The CRLs cited GMP deficiencies at Hengrui Pharma's camrelizumab manufacturing facility and incomplete Bioresearch Monitoring (BIMO) clinical inspections due to FDA travel restrictions. Importantly, the FDA raised no issues regarding rivoceranib's clinical data or its manufacturing site. Ahead of the Type A meeting, the FDA accepted Hengrui Pharma's corrective actions for GMP deficiencies. During the meeting, the FDA confirmed that resubmission could proceed promptly. Additionally, the FDA acknowledged that BIMO inspections, delayed by travel restrictions, could take place after the resubmission.

Saeho Chong, Elevar Chief Executive Officer, “The most critical outcome from our discussion with the FDA is that resubmission of Elevar’s NDA can occur without further remediation at the Hengrui manufacturing site. Elevar left the meeting very motivated and with a clear path forward for resubmission, so patients and providers can soon have access to this novel combination therapy for uHCC where there continues to be a high unmet need. The resubmission will include the CARES-310 landmark analysis recently presented at ASCO, demonstrating the longest median overall survival (mOS) of 23.8 months for any treatment in a global Phase 3 trial for patients with uHCC.”