CRL issued for Rivoceranib-Camrelizumab HCC combo
- Sponsor
- Elevar Therapeutics
- Drug
- rivoceranib/camrelizumab
- Indication
- unresectable or metastatic hepatocellular carcinoma
FDA issued a Complete Response Letter for rivoceranib plus camrelizumab as first-line treatment for unresectable or metastatic hepatocellular carcinoma.
What this means
Rivoceranib and camrelizumab are two drugs that work together to fight liver cancer by blocking tumor blood vessels and helping the immune system attack cancer cells. FDA declined to approve the combination as first-line treatment for advanced liver cancer, citing deficiencies from a cGMP inspection of a manufacturing site listed on the Rivoceranib NDA — the same class of finding that drove the 2024 first-cycle CRL. Elevar (majority-owned by Korea's HLB Co., Ltd.) said the FDA has previously acknowledged the strength of the clinical data supporting the application, and the company plans to address the manufacturing concerns and resubmit.