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 |
|---|---|
| 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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