Pierre Fabre Pharmaceuticals and Atara Biotherapeutics said the FDA agreed to reconsider Ebvallo (tabelecleucel/tab-cel) after the agency previously rejected the therapy for relapsed or refractory EBV+ post-transplant lymphoproliferative disease (EBV+PTLD). The companies said a late-April meeting ended with FDA aligning that a single-arm study, supported by an appropriate historical control, could be considered adequate for review. The shift comes after the FDA’s January complete rejection, when the agency said the same single-arm trial was “not an adequate and well-controlled study.” Instead of launching a new trial, Pierre Fabre and Atara plan to resubmit by adding patients and extending follow-up of the Allele study. European regulators previously approved Ebvallo in 2022 for the same indication, leaving the resubmission path as the near-term catalyst to watch for U.S. patients who currently lack an FDA-approved option.