An off-the-shelf T-cell therapy for people with rituximab-refractory Epstein-Barr virus (EBV) flagged by the FDA for both orphan and breakthrough status is headed into dual phase III trials after the agency green-lighted its developer, Atara Biotherapeutics Inc., to make the move. Earlier data on the candidate, tabelecleucel, formerly known as ATA-129, suggests it might significantly improve the odds of survival for people who develop lymphomas and other lymphoproliferative disorders caused by EBV after solid organ or blood cell transplants.