China-Only Studies Are ‘Problematic,’ US FDA’s Pazdur Says Ahead Of Lilly/Innovent PD-1 Inhibitor Review

New drug applications that rely on patient data from a single country – such as China – are “problematic” and run counter to efforts in the U.S. to increase the diversity of patients enrolled in clinical trials, FDA Oncology Center for Excellence Director Rick Pazdur said during a 14 December session at the “virtual” Biopharma Congress.

Pazdur was asked to discuss the issue in light of an upcoming advisory committee review for Eli Lilly and Company/Innovent Biologics, Inc.’s PD-1 inhibitor sintilimab in non-squamous non-small cell lung cancer