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Innovent/Lilly Face US FDA Setback Due to China-Only PD-1 Trials

publication date: Feb 9, 2022

The US FDA warned Innovent and Eli Lilly that their partnered PD-1 product, Tyvyt, will not be approved because the NDA is based only on China clinical trial data. Although the trial design is similar to previous trials, the participants were all China citizens -- no other ethnic groups were included. The FDA said it could not be sure Tyvyt would be as effective in US citizens or that it was more effective than therapies available in the US. The FDA's Oncology Committee will discuss the Tyvyt application for use with non-small cell lung cancer later this week. More details....

Stock Symbol: (HK: 01801) (NYSE: LLY)

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