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Plea To FDA: Set Realistic Bar For New Breast Cancer Trial Endpoint

 
• By Emily Hayes

Commenting on FDA’s draft guidance for accelerated approval using a relatively new surrogate marker of pathologic complete response, Roche/Genentech is wary that FDA may expect too high a bar for results. BIO asks FDA to consider safety when evaluating “magnitude of benefit.”

Stakeholders are concerned that FDA’s vague requirement for a “large difference” in treatment effect in its draft guidance on using pathologic complete response to support accelerated approval in neoadjuvant breast cancer could cause confusion, dissuade development and set up a de facto comparative efficacy requirement.

FDA has not yet approved any drugs for neoadjuvant (pre-operative) breast cancer, but chemotherapy regimens are increasingly being used earlier...

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More from Clinical Trials

CAR-T Therapy Trials Involving Chinese Labs Will Face Heightened US FDA Scrutiny

 
• By Michael McCaughan

The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.

EU Sees Unified Pathway For Drug/IVD Studies As Key To Future Research Investment

 
• By Vibha Sharma

As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 
• By Sarah Karlin-Smith

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By Sue Sutter

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.

More from R&D

BIO Notebook: Policy Uncertainty Constraining Dealmaking

 
• By Mandy Jackson and Joseph Haas

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 
• By Sarah Karlin-Smith

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By Sue Sutter

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.