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When Oncology NDAs Fail, Clinical Benefit Is Often In Question

 
• By Bridget Silverman

Pre-submission meetings can address questions of clinically meaningful endpoints and appropriate subgroups, avoiding negative regulatory outcomes, FDA analysis suggests.

Common flaws in oncology NDAs that fail to receive approval could have been addressed by the pre-submission meetings encouraged under FDA’s program to increase review efficiency, an agency analysis of failed new molecular entity oncology NMEs concluded.

Many of the failed applications tried to assert a drug benefit without well-controlled trials showing a statistically significant effect on...

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More from Clinical Trials

Australia Targets Clinical Trial Reform, AI Use And Drug Shortages In 12-Month Plan

 
• By Eliza Slawther

Reforming clinical trial regulations, addressing the use of artificial intelligence, mitigating medicines shortages and strengthening ties with other drug regulators are key priorities for Australia’s Therapeutic Goods Administration over the next year.

EU’s Life Sciences Strategy Faces Race Against Time, Says Clinical Trials Community

 
• By Vibha Sharma

The report gave examples of missed opportunities for innovation and patient access, as well as regulatory and operational problems that undermine the conduct of timely clinical trials in Europe.

Sponsors Asked, EMA Delivered: One Handbook To Navigate CTIS

 
• By Vibha Sharma

The European Medicines Agency has revised the sponsor handbook for the Clinical Trials Information System, bringing together guidance that was previously scattered across multiple platforms and documents to help sponsors navigate the trial process more efficiently.

Sarepta Refuses To Stop Elevidys Shipments After Third Death Linked To Gene Therapy Vector

 
• By Mandy Jackson

Sarepta knew about the death in a Phase I trial of SRP-9004 for LGMD when it recently revealed a restructuring plan, but did not disclose the event. The now-discontinued gene therapy candidate uses the same AAV vector as Elevidys, which has been linked to two DMD patient deaths.

More from R&D

UK HRA Sets Targets For Digital Overhaul, Trial Transparency And Trust

 
• By Vibha Sharma

The UK Health Research Authority’s latest three-year strategy sets ambitious targets to make research more transparent. One World Health Organization official believes the authority can go further by setting equally high standards for the timely reporting of clinical trial results.

Otsuka/Lundbeck’s Rexulti PTSD Claim Will Test US FDA AdComm’s Supportive Evidence Flexibility

 
• By Bridget Silverman

Rexulti’s post-traumatic stress disorder sNDA tries to make up for a failed Phase III study by placing a Phase II study into a key evidentiary role, raising questions for the July 18 advisory committee meeting about assessing discordant results and post-hoc analyses.

Organ-On-A-Chip: Upcoming US FDA Guidance Could Help Flesh Out ‘Roadmap’

 
• By Michael McCaughan

The FDA is pushing the use of novel alternatives to animal models, but the Government Accountability Office said sponsors need more clarity and hopes an upcoming guidance will help.