The U.S. FDA agreed to reconsider its earlier shock rejection of Pierre Fabre Pharmaceuticals and Atara Biotherapeutics’ off-the-shelf T-cell therapy Ebvallo (tabelecleucel) after the companies reached an updated understanding of what kind of evidence could support approval. The agency told the firms that a single-arm study with an appropriate historical control could be “adequate and well controlled” for the resubmission. The therapy is targeted to patients with relapsed or refractory Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) who failed anti-CD20 therapy. After a January complete response letter, the companies said they will resubmit the biologics license application with additional patients and longer follow-up from the Allele study rather than starting a new trial. The U.S. decision comes after European regulators already approved Ebvallo for the same indication in 2022, underscoring the evidence gap the FDA previously flagged around interpretability of the U.S. dataset. A new FDA review plan effectively reopens a path for a therapy in an ultra-rare setting where few alternatives exist.