“Regulatory flexibility” to rely on Chinese study data for Innovent Biologics, Inc./Eli Lilly and Company's sintilimab is not warranted because the PD-1 inhibitor does not fulfill an unmet need in the US for non-small cell lung cancer and there is no evidence it provides a safety or efficacy advantage over available therapy, the US Food and Drug Administration said.
‘Regulatory Flexibility’ For Innovent/Lilly’s Sintilimab Not Warranted, US FDA Says
Advisory committee will vote on whether an additional trial demonstrating applicability of results from the Phase III study in China is needed prior to approval; agency says PD-1 inhibitor does not fulfill an unmet need in the US for non-small cell lung cancer.
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