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Bladder Cancer: More Questions Than Answers With pCR Endpoint

 
• By Derrick Gingery

Pathologic complete response eventually may be a surrogate endpoint for survival, but researchers and the US FDA outlined several problems that must be resolved first.

Bladder-cancer-cells
Validating pCR as a surrogate endpoint could help advance drug development in muscle-invasive bladder cancer. • Source: Shutterstock

Physicians and researchers laid out so many problems with using pathologic complete response in muscle-invasive bladder cancer that some attendees at a recent workshop co-sponsored by the US Food and Drug Administration may have thought it was not worth exploring as a potential surrogate endpoint.

But Evan Yu, medical director for clinical research support at the Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium,...

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More from Clinical Trials

Cancer Drug Trials Must Be Ready To Pivot As Standards Of Care Shift

 
• By Sue Sutter

Upfront planning is critical to navigating a change in the standard of care while a randomized registrational trial is underway. Sponsors must also be mindful to what patients and clinicians will consider an acceptable comparator arm, a new white paper states.

Biohaven’s Troriluzole And The Era Of Real-Time Complete Response Letters

 
• By Michael McCaughan

US FDA’s rejection of Biohaven’s troriluzole is a huge disappointment for patients with SCA and the company. But it is also a notable example of how communication strategies are changing now that FDA is making its ‘complete response’ letters public.

Brazil To Fix Regulatory Reliance Shortfalls & Speed Up Approvals

 
• By Francesca Bruce

Regulatory reliance processes for drug registration and clinical trial application approvals in Brazil have not met their “full potential,” says Brazil’s medicines regulator.

UK Targets Contamination Tests & Pharmacokinetic Studies In Animal Testing Phase Out

 
• By Eliza Slawther

Pharmaceutical companies will be expected to phase out certain animal tests in the drug development process under a UK roadmap aimed at pivoting towards using alternative models, such as organ-on-a-chip systems and artificial intelligence.

More from R&D

Novel Oncology Endpoints Take Time, Require Broad Outreach, US FDA Says

 
• By cole werble

The US FDA’s oncology team is emphasizing a methodical approach to developing novel endpoints like MRD or ctDNA and that community buy-in is important, not just regulatory standards.

Where RWE Studies Stand In India And Bharat Serums’ Plans For The World’s Largest One

 
• By Vibha Ravi

Real-world evidence (RWE) studies in India face challenges like lack of data reliability and uniformity and absence of clear guidelines but firms like Bharat Serums have scored a regulatory win. Pink Sheet examines the RWE landscape and the BSV case study for lessons in beating the odds

UniQure Is Latest Gene Therapy Sponsor Surprised By US FDA Reversal

 
• By Bridget Silverman

UniQure’s Huntington's disease filing plans are in disarray after the FDA reversed course on the company's regulatory strategy employing real-world evidence and accelerated approval.