'Well underway': FDA calls for faster confirmatory trials for accelerated approvals
The FDA’s Oncology Center of Excellence on Thursday outlined what more the agency can do to speed up confirmatory trials to ensure drugs approved under the accelerated pathway are clinically beneficial.
Before reviewing two Acrotech Biopharma therapies, FDA officials took questions from an advisory committee of cancer experts on the agency’s wider plans for reforming the accelerated approval process. Acrotech markets two drugs: Folotyn (pralatrexate) and Beleodaq (belinostat), both of which received accelerated approval, are indicated for relapsed or refractory peripheral T cell lymphoma (PTCL) and have lingered for years without completing confirmatory trials.
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