FDA deems Ebvallo single-arm trial sufficient for review
Updated
Updated · STAT · May 7
FDA deems Ebvallo single-arm trial sufficient for review
13 articles · Updated · STAT · May 7
Pierre Fabre Pharmaceuticals and Atara Biotherapeutics said a late-April meeting ended with the agency reversing January's view that the completed study was insufficient.
The shift reopens a path to potential approval for Ebvallo, a therapy for a rare blood cancer, after the FDA had previously cited flaws in the same trial.
The review was handled by the FDA's Center for Biologics Evaluation and Research, whose then-leader Vinay Prasad left the agency at the end of April.
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