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

US Food and Drug Administration Oncology Center of Excellence Director Rick Pazdur believes poor trial design choices are likely responsible for many situations where one PD-1/L-1 inhibitor has succeeded in an indication and another one failed, leaving open the possibility that FDA might take a lenient approach toward an accelerated approval application for such a cancer immunotherapy despite a failed trial.

FDA wanted to be transparent about the various trial successes and failures for checkpoint inhibitors post-accelerated approval and that is one of the reasons the agency brought some that have failed to confirm clinical benefit to the three-day April Oncologic Drugs Advisory Committee