The FDA agreed to reconsider Ebvallo (tabelecleucel) after a surprise rejection earlier in 2026, giving Pierre Fabre Pharmaceuticals and Atara Biotherapeutics a new potential path toward review. The companies said a late-April meeting with FDA officials resulted in the agency accepting that their completed single-arm study could support resubmission, provided appropriate controls and framing are used. Ebvallo is designed for patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have failed anti-CD20 therapy. Previously, the FDA found the single-arm evidence “not adequate and well-controlled,” citing interpretability issues with the Allele study and demanding additional substantiation. Under the new plan, Pierre Fabre and Atara intend to resubmit using the existing single-arm dataset expanded with more patients and longer follow-up. European regulators previously approved the therapy for the indication in 2022, setting a different regulatory trajectory from the U.S. course to date.