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FDA’s Pazdur Blames Trial Design Errors For Some PD-1/L1 Failures, Foreshadows Potential Agency Leniency

Executive Summary

US FDA Oncology Center of Excellence Director Rick Pazdur says PD-1/L1 drugs are very similar and hypothesizes that when competitors show differing results in the same indication it's more about trial design than the drug. FDA oncology experts also weighed in on regulatory clearance of Chinese-developed checkpoint inhibitors and trial endpoints that have come under outside scrutiny.

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