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China-Only Studies Are ‘Problematic,’ US FDA’s Pazdur Says Ahead Of Lilly/Innovent PD-1 Inhibitor Review

Executive Summary

February advisory committee for sintilimab expected to address three main questions about applications relying on single-country data.

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Lilly/Innovent Experience Show Hurdles Remaining For Chinese PD-1 Inhibitors

China has fielded several homegrown checkpoint inhibitors, using lower cost as an argument for the US market, but sintilimab – a key test case – has underscored FDA skepticism.

‘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.

Innovent/Lilly’s Sintilimab, Developed In China, May Be Headed For Troubled US Waters

Ahead of advisory committee, FDA officials raise concerns about the PD-1 inhibitor, which was submitted on the basis of a Phase III trial conducted solely in China. OCE’s Pazdur and Singh make the case for a global, harmonized approach to cancer drug development using multiregional trials.

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