The FDA agreed to reconsider approval of Pierre Fabre and Atara Biotherapeutics’ twice-rejected Ebvallo (tabelecleucel) after a new meeting with regulators. The companies said the agency accepted that a single-arm approach—using an appropriate historical control—could support a resubmission for relapsed or refractory EBV+ post-transplant lymphoproliferative disease after failure of anti-CD20 therapy. Atara and Pierre Fabre said the resubmission would rely on the already completed single-arm Allele study, rather than launching a separate new trial. The FDA previously rejected the BLA in January, citing deficiencies it said made the trial results “insufficient” and “not adequate and well controlled.” The path forward could give patients an off-the-shelf option for an ultra-rare, aggressive malignancy with limited treatment alternatives, while also signaling that the FDA’s bar for single-arm evidence may be more flexible in tightly defined contexts.