FDA again rebuffs Atara’s cell therapy... company calls agency reversal a 'complete reversal'

The FDA issued another rejection for Atara Biotherapeutics’ allogeneic T‑cell therapy tabelecleucel (Ebvallo) for EBV‑positive post‑transplant lymphoproliferative disease, reversing prior agency signals that the single‑arm Allele trial could support approval under accelerated pathways. Atara and partner Pierre Fabre said the second complete response letter represented a reversal in regulatory position, and Atara criticized the shift. The companies are evaluating next steps as the agency cited unresolved concerns in its correspondence.