Pierre Fabre and Atara Biotherapeutics won a significant pivot from the U.S. FDA on Ebvallo (tabelecleucel) after the agency’s earlier surprise rejection. The FDA agreed to reconsider approval support using a single-arm study paired with an appropriate historical control framework, according to company statements. The therapy is aimed at patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disease (EBV+PTLD) after failure of an anti-CD20 regimen. The earlier FDA decision in January cited the same single-arm trial as not adequate and well-controlled due to multiple deficiencies, but the latest discussion establishes a resubmission pathway without initiating a new separate trial. Pierre Fabre’s CEO for its U.S. subsidiary said the companies will finalize a resubmission plan with additional patients and longer follow-up under the agreed framework, following earlier progress in Europe where the immunotherapy received approval in 2022.