Elevar Therapeutics reports plans for near-term resubmission of NDA for first-line treatment option for unresectable hepatocellular carcinoma following Type A FDA meeting

The meeting was requested by Jiangsu Hengrui Pharmaceuticals (Hengrui Pharma) to address items cited in the May 16 FDA Complete Response Letters (CRLs) sent to Hengrui Pharma and Elevar. The original NDA was submitted by Elevar in May 2023.

The CRL cited GMP deficiencies at the Hengrui Pharma facility where camrelizumab is manufactured and incomplete Bioresearch Monitoring (BIMO) clinical inspections due to FDA travel restrictions. The FDA did not indicate any issues related to clinical data or with the manufacturing site for rivoceranib. Prior to the Type A meeting, the FDA had accepted Hengrui Pharma’s written responses to GMP deficiencies. During the meeting, the FDA confirmed resubmission can occur without delay. The FDA also confirmed BIMO inspections due to FDA travel restrictions may occur after resubmission.