Atara Biotherapeutics Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application $(BLA.SI)$ for their innovative therapy, tabelecleucel (tab-cel®), with a Priority Review status. This application pertains to the use of tab-cel as a monotherapy for treating Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) in both adult and pediatric patients who have undergone at least one prior therapy. Notably, there are currently no FDA-approved therapies available for this condition. The Priority Review includes a Class 2 Resubmission Prescription Drug User Fee Act (PDUFA) target action date set for January 10, 2026. This development marks a significant step towards introducing this first-of-its-kind treatment to patients in the U.S.
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