NDA resubmitted to FDA for rivoceranib + camrelizumab as first-line systemic treatment for unresectable or metastatic hepatocellular carcinoma
Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd., announced the FDA accepted the resubmission of a new drug application (NDA) 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 hepatocellular carcinoma (uHCC)
The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 20, 2025.
The resubmission included the final analysis of the Phase III CARES-310 study presented during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting on June 1, which reported median overall survival (mOS) of 23.8 months, the longest mOS for any treatment in a global Phase III trial for patients with uHCC, confirming the combination of camrelizumab and rivoceranib continued to show sustained long-term survival as a first-line treatment for patients with uHCC.
With the efficacy results generally consistent across all subgroups, the data suggest the combination has the potential to benefit a global uHCC population. The data also demonstrated consistent efficacy across patients with both viral and non-viral etiologies
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