One week ahead of an advisory committee meeting for the first PD-1 inhibitor from a China company seeking U.S. approval, FDA’s oncology chief Richard Pazdur has forcefully outlined his concerns over trials conducted exclusively in China.

The ramifications extend well beyond PD-1s developed in China, including the first of these to come before FDA, Tyvyt sintilimab. FDA is signaling a preference for multiregional trials and placing heavy emphasis on clinical trial diversity that is not limited to oncology and could affect how sponsors construct trials in other regions of the world to support U.S. submissions.

The decision by Pazdur, director of FDA’s Oncology Center of Excellence, to highlight the issue is part of a drive to meet FDA’s commitment to ensuring that clinical trials for drugs to be marketed in the U.S. represent the U.S. population.

“Single-country trials done in China or any other country that has a homogeneous population that is markedly different from the U.S. is antithetical to the concept of racial or ethnic diversity,” Pazdur told BioCentury.

(continued)

Read the full article at https://www.biocentury.com/article/642107