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.
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Accelerated Approval: US FDA Should Explain Why An Ongoing Trial Is Not Required
Having a confirmatory trial underway at the time of approval should be the ‘default expectation’ and the agency should publicly explain when and why it grants exceptions to this rule, experts said at a National Academies meeting on accelerated approval.
US FDA Says Confirmatory Trials Should Start Before Accelerated Approval But Is Not ‘Dogmatic’
Beginning confirmatory trials before the accelerated approval is granted shortens the time between clearance and the confirmation of benefit, when patients are at risk, said Oncology Center of Excellence Director Richard Pazdur.
‘On-And Off-Ramps’ For Cancer Accelerated Approvals: FDA Suggests Earlier Randomized Trials
Leaders of FDA’s oncology center say sponsors could initiate a single randomized trial prior to receiving accelerated approval or conduct a single-group AA study concurrently with a randomized trial. FDA and sponsor could agree in advance on criteria for approval and withdrawal.