Shots:
- The US FDA has received the resubmitted NDA for rivoceranib + camrelizumab for the 1L systemic treatment option for unresectable or metastatic hepatocellular carcinoma (uHCC)
- Following an FDA Complete Response Letter in Jul 2026 for its Jan NDA submission, Elevar Therapeutics resubmitted the NDA on October 9, 2026, after working with the FDA and partner Hengrui Pharma to address the CRL
- NDA was based on the global P-III (CARES-310) trial assessing camrelizumab + rivoceranib vs sorafenib in 1L uHCC, which showed an mOS of 23.8 vs 15.2mos.; results were generally consistent across various subgroups. Final analysis was published in The Lancet Oncology
Ref: Globenewswire | Image: Elevar Therapeutics | Press Release
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com
