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.

Bridge over water
Multiregional trials will be the true 'bridge' for global drug development and regulatory harmonization, FDA oncology leaders say. • Source: Alamy

The US Food and Drug Administration is signaling concerns about relying on Phase III data generated in a single country ahead of a 10 February advisory committee review of Innovent Biologics, Inc./Eli Lilly and Company’s PD-1 inhibitor sintilimab in non-small cell lung cancer.

In a comment published in Lancet Oncology on 4 February, Oncology Center of Excellence leaders Harpreet Singh and Richard Pazdur say the sintilimab application raises questions regarding use of data from a single country – in this

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