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# NDA for Liver Cancer Combo Therapy Resubmitted
- URL: https://www.fdaweb.com/nda-for-liver-cancer-combo-therapy-resubmitted/
- Published: 2024-10-21T12:00:00.000Z
- Updated: 2026-09-14T14:44:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158020

FDA has accepted an Elevar Therapeutics NDA resubmission for its investigational drug rivoceranib, an oral VEGF-TKI, in combination with camrelizumab, a PD-1 inhibitor, as a first-line systemic treatment for unresectable or metastatic liver cancer. The agency has set a user fee review action target date of 3/20/2025.

In May, FDA issued Elevar and its Chinese partner, Jiangsu Hengrui Pharmaceuticals, a complete response letter that cited chemistry, manufacturing, and controls deficiencies found during a recent inspection, according to the companies. It also indicated that due to travel restrictions, inspections at key clinical trial sites in Russia and Ukraine had not been completed.

The resubmission includes the final analysis of the Phase 3 [CARES-310 study](https://ascopubs.org/doi/10.1200/JCO.2024.42.16%5Fsuppl.4110?ref=fdaweb.com) that showed median overall survival of 23.8 months, the longest for any treatment in a global Phase 3 trial for patients with unresectable or metastatic liver cancer, according to the companies. “The data also demonstrated consistent efficacy across patients with both viral and non-viral etiologies,” they say.