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# Elevar Resubmitting Cancer Drug NDA
- URL: https://www.fdaweb.com/elevar-resubmitting-cancer-drug-nda/
- Published: 2024-07-09T12:00:00.000Z
- Updated: 2026-09-14T14:34:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157311

Elevar Therapeutics says it will soon resubmit its NDA for rivoceranib in combination with camrelizumab as a first-line treatment option for unresectable hepatocellular carcinoma. A company [statement](https://elevartherapeutics.com/2024/07/09/elevar-therapeutics-first-line-treatment-option/?ref=fdaweb.com) says the resubmission follows a 7/2 Type A meeting with FDA that addressed items in the agency’s 5/16 complete response letter.

The letter cited good manufacturing practice deficiencies at the Hengrui Pharma facility where camrelizumab is manufactured and incomplete bioresearch monitoring inspections due to FDA travel restrictions. FDA did not reference any issues related to clinical data or with the rivoceranib manufacturing site, the statement says.

Camrelizumab is a humanized monoclonal antibody that binds to the programmed death-1 receptor. FDA granted it orphan drug designation for hepatocellular carcinoma in 4/2021\. Rivoceranib, a small-molecule tyrosine kinase inhibitor is said to be a highly potent inhibitor of vascular endothelial growth factor receptor 2, a primary pathway for tumor angiogenesis. FDA has given it an orphan drug designation for gastric cancer, adenoid cystic carcinoma, and unresectable hepatocellular carcinoma.