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

 
• By Sue Sutter

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

More from US FDA Performance Tracker

More from Regulatory Trackers