Atara Biotherapeutics submits BLA to FDA for tabelecleucel

Atara Biotherapeutics announced that Atara has submitted a biologics license application, or BLA, to the FDA 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. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate. There are no FDA approved therapies in this treatment setting.