Casualty Of Change? Innovent/Lilly’s Chinese PD-1 Inhibitor Sintilimab Falls Hard At US FDA Panel

 
• By Sue Sutter

Advisory committee says additional trials needed to demonstrate applicability of ORIENT-11 results to US population; in opting to seek approval only with Chinese data, Innovent said it relied on 2019 comments by FDA’s Richard Pazdur, but the oncology center head said therapeutic and societal changes have caused an evolution in the agency’s thinking.

Step backwards
Single-country submissions are 'a step backward' in efforts to promote clinical trial diversity and multi-regional trials, FDA's top oncology official says. • Source: Alamy

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