Pierre Fabre and Atara Biotherapeutics said the FDA will reconsider Ebvallo (tabelecleucel/tab-cel) after the agency previously rejected the therapy using the same underlying single-arm evidence package. The companies said regulators agreed that an approach using a single-arm study with an appropriate historical control could support a future application review. The update follows a January complete response letter in which the FDA said the Allele trial data were “insufficient” and not adequately controlled. Atara and Pierre Fabre now plan to resubmit with additional patients and longer follow-up rather than restart a new trial, aiming to address the FDA’s earlier concerns. Because Ebvallo is intended for patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disease after anti-CD20 therapy failure, the resubmission path keeps an off-the-shelf option in scope for an ultra-rare indication with high unmet need. The change also signals potential flexibility in how the FDA evaluates control strategy for rare diseases. For the cell-therapy sector, the decision matters beyond Ebvallo: it highlights how documentation quality, endpoint interpretability, and historical-control framing can determine whether previously rejected single-arm programs can be turned into approvable dossiers.