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

 
• By Sarah Karlin-Smith

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.

Richard Pazdur
Rick Pazdur And Other Oncology Center of Excellence Leaders Weighed In On Checkpoint Inhibitors

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...

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US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
• By Sarah Karlin-Smith

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