Complete Response Letter for camrelizumab + rivoceranib in unresectable liver cancer
The FDA has issued a complete response letter for frontline camrelizumab plus rivoceranib as a treatment for those with unresectable or metastatic hepatocellular carcinoma (HCC), according to a news release from the developers, Jiangsu Hengrui Pharmaceuticals Co., Ltd.
The regulatory agency’s complete response letter highlighted deficiencies related to its inspection of the developer’s manufacturing site. The agency will assess how developers respond to these manufacturing issues. Additionally, the FDA was not able to fully evaluate the camrelizumab combination within the review period due to travel restrictions in some countries.
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