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‘Regulatory Flexibility’ For Innovent/Lilly’s Sintilimab Not Warranted, US FDA Says

 
• By Sue Sutter

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.

Bending over backwards
FDA is not exactly bending over backwards to approve sintilimab. • Source: Alamy

“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.

In a briefing

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