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

Executive Summary

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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