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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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MHRA Backs Bacteriophage Innovation To Fight Antimicrobial Resistance

 
• By Eliza Slawther

The UK regulator wants to help companies to develop bacteriophages for the treatment of infections. Its first guidance on this topic offers advice to researchers and sets out the regulatory requirements they will need to meet.

Clinical Trials Nonprofit Fights for Access Despite DEI Crack-Down

 
• By Sue Sutter

The Clinical Trials Access Collaborative (CTAC) will build on a pilot program's work to bolster community-based clinical research infrastructure so "anyone who wants to participate in clinical trials can and do it closer to home,” CEO Tesheia Harris said in an interview.

US FDA Cell-Gene Therapy Head Says Agency Has Revived Stalled Programs

 
• By Sarah Karlin-Smith

CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.

Canada Cuts Red Tape With Single Ethics Review For Trials

 
• By Neena Brizmohun

A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.

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Australia Looks To Modernize Human Tissue Laws, Improving Access For Researchers

 
• By Eliza Slawther

Australia is reviewing its human tissue laws for the first time in almost 50 years, and is hoping to reduce barriers to access for scientific researchers, for instance by addressing issues with access to cell lines for developing drugs.

US FDA Cell-Gene Therapy Head Says Agency Has Revived Stalled Programs

 
• By Sarah Karlin-Smith

CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.

Canada Cuts Red Tape With Single Ethics Review For Trials

 
• By Neena Brizmohun

A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.