The US FDA agreed to reconsider approval of Atara Biotherapeutics and Pierre Fabre Pharmaceuticals’ off-the-shelf T-cell therapy Ebvallo (tabelecleucel/tab-cel) after a second meeting that walked back the agency’s earlier objections. The companies said the agency is open to using the already completed single-arm trial as a basis for review if supported with an appropriate historical control approach. The reconsideration centers on Ebvallo’s indication for relapsed or refractory Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+PTLD) after failure of an anti-CD20 regimen. European regulators already approved the therapy in 2022, but the FDA issued a complete response letter earlier this year on the grounds that the trial was not “adequate and well-controlled.” Atara and Pierre Fabre plan to resubmit the BLA without launching a new standalone trial, adding more patients and extending follow-up data from the Allele study. The companies framed the FDA’s discussion as productive and said they expect to finalize a resubmission plan with the agency in the coming weeks.