Atara Biotherapeutics announces FDA acceptance of BLA for tabelecleucel

Atara Biotherapeutics (ATRA) announced that the FDA has accepted the filing of its biologics license application for 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. There are no FDA approved therapies in this treatment setting. The BLA has been granted priority review with a Class 2 Resubmission Prescription Drug User Fee Act target action date of January 10, 2026.