The FDA has agreed to reconsider its January decision to reject Ebvallo (tabelecleucel/tab-cel) for relapsed or refractory EBV-positive post-transplant lymphoproliferative disease (EBV+ PTLD), according to Pierre Fabre Pharmaceuticals and Atara Biotherapeutics. The agencies’ position now allows the companies to use their completed single-arm trial as the basis for a potential approval, provided the study is framed with an appropriate historical control. The companies say they plan to resubmit without launching a new separate trial. They will add more patients and extend follow-up for the single-arm study, known as Allele. This update matters because the FDA previously found the trial “not adequate and well-controlled,” effectively blocking progress for the cell therapy. A European regulator approved Ebvallo for the indication in 2022, setting the stage for a potential catch-up in the U.S. market. Ebvallo is an off-the-shelf immunotherapy made from EBV-specific cytotoxic T cells derived from healthy EBV-seropositive donors.