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# Elevar Therapeutics NDA for Liver Cancer
- URL: https://www.fdaweb.com/elevar-therapeutics-nda-for-liver-cancer/
- Published: 2023-07-18T12:00:00.000Z
- Updated: 2026-09-14T18:44:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154902

FDA has accepted for review an Elevar Therapeutics NDA for rivoceranib, an oral tyrosine kinase inhibitor in combination with camrelizumab, a PD-1 inhibitor, as a first-line treatment for unresectable hepatocellular carcinoma (uHCC). The agency has set a user fee review action target date of 5/16/2024.

The NDA is based on data from the [Phase 3 CARES 310 study ](https://elevartherapeutics.com/2022/09/07/elevar-therapeutics-announces-camrelizumab-plus-rivoceranib-significantly-prolonged-overall-survival-and-progression-free-survival-versus-sorafenib-in-patients-with-unresectable-hepatocellular-carcino/?ref=fdaweb.com)(NCT03764293) that showed “rivoceranib plus camrelizumab demonstrated statistically significant and clinically meaningful prolonged overall survival (OS) and progression-free survival (PFS), and improved overall response rate versus sorafenib, a standard first-line treatment for uHCC,” according to the company. The data showed that median OS for camrelizumab plus rivoceranib was 22.1 months vs. 15.2 months for those on sorafenib. And median PFS for the combination was 5.6 months ss. 3.7 months for sorafenib, it says.