The FDA has agreed to reconsider approval for Atara Biotherapeutics and Pierre Fabre Pharmaceuticals’ allogeneic T-cell therapy Ebvallo (tabelecleucel) after a surprise January rejection. The companies said a late-April meeting led to a potential path where a single-arm study with an appropriate historical control could be “adequate and well controlled” for a BLA review. Ebvallo targets EBV+ post-transplant lymphoproliferative disease (EBV+ PTLD) in patients who have failed an anti-CD20 regimen. European regulators approved the therapy for the indication in 2022, but the U.S. review questioned whether the Allele single-arm trial could support regulatory standards. Atara and Pierre Fabre plan to resubmit without launching a new trial, instead adding patients and longer follow-up to the existing dataset. The approach, if accepted, could compress timelines for an ultra-rare, aggressive indication that currently has no FDA-approved options.