FDA Reconsiders Rejection of Ebvallo Cell Therapy for Rare Disease Treatment
The FDA has decided to reconsider its previous rejection of the T-cell therapy Ebvallo, developed by Pierre Fabre Pharmaceuticals and Atara Biotherapeutics. Initially rejected in January 2026 due to concerns over the adequacy of a single-arm trial, the FDA has now agreed that such a study, with an appropriate historical control, could be sufficient for approval. Ebvallo, also known as tabelecleucel or tab-cel, is intended for patients with relapsed or refractory Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+PTLD) who have not responded to anti-CD20 treatment. The therapy has already been approved in Europe since 2022. The companies plan to resubmit their application with additional patient data and extended follow-up from the original study. 
