Atara Biotherapeutics announces FDA acceptance of tabelecleucel BLA

Atara Biotherapeutics (ATRA) and Pierre Fabre Pharmaceuticals, or PFP, announced the acceptance by FDA of the Biologics License Application (BLA) and Priority Review of tabelecleucel, indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease who have received at least one prior therapy. Atara resubmitted the tabelecleucel BLA on July 11, having in collaboration with PFP, swiftly addressed the third-party manufacturing facility observations outlined in the January 2025 Complete Response Letter. Tabelecleucel is an allogeneic, off the shelf, EBV-specific T-cell immunotherapy which targets and eliminates EBV-infected cells. Since March 31, 2025, PFP has assumed global responsibility for tabelecleucel manufacturing of commercial product for European markets and for global clinical trial supply. On July 15, 2025, Atara Biotherapeutics transferred the tabelecleucel Investigational New Drug Application to Pierre Fabre Medicament, a subsidiary of Pierre Fabre Laboratories. As per the terms of the restated exclusive worldwide licensing agreement between Atara and Pierre Fabre Laboratories, Atara is responsible for regulatory procedures up until BLA transfer to Pierre Fabre Pharmaceuticals.