The FDA agreed to reconsider its shock rejection of Pierre Fabre and Atara Biotherapeutics’ EBV-specific T-cell therapy Ebvallo (tabelecleucel/tab-cel), opening a potential route to approval using a single-arm study design. The companies said the agency indicated that an appropriate historical control could make the resubmission “adequate and well controlled” for patients with relapsed or refractory EBV+ post-transplant lymphoproliferative disease who failed an anti-CD20 regimen. Ebvallo previously failed an FDA decision in January on the basis that the underlying single-arm trial evidence was not adequate and well controlled. The resubmission plan will include additional patients and longer follow-up of the Allele study rather than launching a new trial. The European regulators had already approved the therapy in 2022, making a U.S. pathway shift notable for a population where median survival after standard treatment failure is measured in weeks to months.