Posted by Michael Wonder on 18 May 2023
Elevar Therapeutics submits new drug application to FDA for combination of rivoceranib and camrelizumab as first-line treatment option for unresectable hepatocellular carcinoma
17 May 2023 - Elevar Therapeutics today announced it submitted a new drug application to the US FDA for its investigational drug rivoceranib, an oral tyrosine kinase inhibitor, in combination with camrelizumab, a PD-1 inhibitor, as a first-line treatment option for unresectable hepatocellular carcinoma.
The new drug application is supported by positive clinical data from the Phase 3 CARES 310 study, in which rivoceranib plus camrelizumab demonstrated statistically significant and clinically meaningful prolonged overall survival and progression-free survival, and improved overall response rate versus sorafenib, a standard first-line treatment for unresectable hepatocellular carcinoma.
