The FDA agreed to reconsider an approval path for Atara Biotherapeutics and Pierre Fabre Pharmaceuticals’ EBV-specific T-cell therapy Ebvallo (tabelecleucel), following the agency’s earlier shock rejection. The companies said a late-April meeting with FDA officials accepted that a single-arm study with an appropriate historical control could be “adequate and well controlled” to support a resubmission. The decision reopens a high-stakes approval track for a therapy previously authorized in Europe but blocked in the US. Ebvallo is intended for patients with relapsed or refractory EBV+ post-transplant lymphoproliferative disease after anti-CD20 failure, a setting described as ultra-rare and rapidly progressive. The companies plan to resubmit without launching a new trial, instead adding patients and extending follow-up from the already-completed single-arm Allele study.