Posted by Michael Wonder on 11 Jul 2026
Elevar Therapeutics receives FDA complete response letter for combination of rivoceranib and camrelizumab as a first-line treatment for unresectable or metastatic hepatocellular carcinoma
10 July 2026 - Elevar Therapeutics today announced that the US FDA issued a complete response lette regarding its new drug application for the combination of rivoceranib, an oral TKI, and camrelizumab, an anti-PD-1 antibody, as a first-line systemic treatment option for unresectable or metastatic hepatocellular carcinoma.
The FDA's decision was related to deficiencies identified during a cGMP inspection of a manufacturing site listed on the rivoceranib new drug application.
