Camrelizumab FDA Approval Status

FDA Approved: No
Generic name: camrelizumab
Company: Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Treatment for: Hepatocellular Carcinoma

Camrelizumab is a humanized monoclonal antibody targeting the programmed death-1 (PD-1) receptor in development for the treatment of hepatocellular carcinoma.

Camrelizumab is a PD-1 inhibitor that works by blocking the interaction between PD-1 and PD-L1 to activate the immune system to kill cancer cells.
Camrelizumab is currently approved in China under the brand name AiRuiKa^®for the treatment of hepatocellular carcinoma, Hodgkin’s lymphoma, esophageal squamous cell carcinoma, nasopharyngeal carcinoma, and non-small cell lung cancer.
The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to camrelizumab for advanced hepatocellular carcinoma in April 2021.
A New Drug Application (NDA) was submitted to the FDA for camrelizumab in combination with rivoceranib for the first-line treatment of unresectable hepatocellular carcinoma (uHCC) in May 2023.

Development timeline for camrelizumab

Date	Article
Oct 21, 2024	Elevar Therapeutics Announces FDA Acceptance of New Drug Application Resubmission for Rivoceranib in Combination with Camrelizumab as a First-line Systemic Treatment for Unresectable Hepatocellular Carcinoma
Sep 23, 2024	Elevar Therapeutics Resubmits New Drug Application to FDA for Combination of Camrelizumab plus Rivoceranib as First-Line Treatment Option for Unresectable Hepatocellular Carcinoma Boosted by CARES-310 Leading Overall Survival Analysis
May 17, 2023	Elevar Therapeutics Submits New Drug Application to FDA for Combination of Rivoceranib and Camrelizumab as First-Line Treatment Option for Unresectable Hepatocellular Carcinoma

Further information

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