US FDA Releases Draft Guidance on Oncology Clinical Trials Seeking Accelerated Approval
March 27, 2023
In a new draft guidance, the US FDA proposes two strategies to make clinical trials for cancer drugs better support accelerated approval applications for cancer drugs. Such applications are expected to be followed by confirmatory studies that often don’t materialize or yield negative results. The first suggestion is to move to a single trial for accelerated approval that also confirms potential health benefits.
According to Emily Kimber, “The FDA adds that the ‘one-trial’ approach has the advantage of providing quicker verification of the benefits, stating: ‘The one-trial approach maintains efficiency in drug development by providing early access to an investigational drug using the accelerated approval pathway, while ensuring that a post marketing trial is fully accrued and well underway to verify longer term benefit in a timely fashion.’”
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(Source: PM Live, March 27th, 2023)
