FDA Issues Response for Camrelizumab
The FDA has issued a second complete response letter (CRL) for camrelizumab plus rivoceranib as a frontline treatment for patients with unresectable or metastatic hepatocellular carcinoma (HCC), according to a news release
According to Korean news sources, the FDA decision was issued March 20, and the CRL did not specify what deficiencies regulators found, according to HLB Group chairman, Jin Yang-gon. Additionally, Antengene Corporation, who developed camrelizumab, will contact the FDA to address concerns raised in the CRL.
Data in this indication came from a presentation of the final analysis of the phase III CARES-310 study (NCT03764293), presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, evaluating treatment with camrelizumab/rivoceranib vs sorafenib (Nexavar) in patients with unresectable or metastatic HCC (uHCC). Findings from the study reveal a median overall survival (OS) benefit with camrelizumab/rivoceranib vs the standard of care (SOC) tyrosine kinase inhibitor (TKI) inhibitor, sorafenib (Nexavar) at 23.8 months (95% CI, 20.6-27.2) vs 15.2 months (95% CI, 13.2-18.5), respectively (HR, 0.64; 95% CI, 0.52-0.79; P < .0001). Additionally, the median progression-free survival (PFS) was 5.6 months (95% CI, 5.5-7.4) with the combination therapy vs 3.7 months (95% CI, 3.1-3.7) with SOC (HR, 0.54; 95% CI, 0.44-0.67; P < .0001).
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