Accelerated Approvals Convert Much Faster If Confirmatory Trial Already Underway, FDA Cancer Data Shows

Oncology Center of Excellence’s ‘Project Confirm’ finds that if a confirmatory trial is ongoing at the time of accelerated approval, conversion to regular approval takes an average of three years versus 4.9 years if the trial starts after AA.

Clinical trial
Confirmatory trial status at approval is one of the most important factors in converting an accelerated approval to a full approval, FDA said. • Source: Shutterstock

Data out of the Oncology Center of Excellence’s “Project Confirm” underscore the benefit of drug sponsors starting confirmatory trials before accelerated approval is granted, with an application’s conversation to full approval occurring nearly two years earlier than if the confirmatory studies are not underway at the time of AA.

If a confirmatory trial is ongoing at the time of accelerated approval, conversion to regular approval takes an average of...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Review Pathways

Elevidys Helps Sarepta To First US FDA Platform Technology Designation

 

Sarepta's rAAVrh74 vector, used in the marketed Duchenne muscular dystrophy gene therapy Elevidys and across the company's limb girdle muscular dystrophy pipeline, earned a platform designation as the lead LGMD candidate prepares for BLA filing.

US FDA’s Rising First-Cycle Complete Response Rate Draws Congress’ Attention

 
• By 

The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.

What UK’s Clinical Trials Overhaul Means For Orphan Drug Developers

 

The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.

Nipah Vaccine With ‘Pandemic Potential’ Wins EMA PRIME Designation

 

The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.

More from Pathways & Standards

Generic Drug Office’s Policy Staff Returning To US FDA

 

The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.

Nipah Vaccine With ‘Pandemic Potential’ Wins EMA PRIME Designation

 

The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.

Elegy For SACHRP: US HHS Research Protection Panel Tackled Tough Pediatric Trial Questions

 

The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.