Pierre Fabre Pharmaceuticals, with support from Thousand Oaks, California-based Atara Biotherapeutics (Nasdaq: ATRA), resubmitted a Biologics License Application (BLA) to the US FDA on September 30, 2026 for tabelecleucel (Ebvallo), an allogeneic EBV-specific T-cell immunotherapy. The targeted indication is to treat adults and children aged two years and older with relapsed/refractory EBV-positive post-transplant lymphoproliferative disease (EBV+ PTLD) following solid organ transplant or hematopoietic cell transplant.
The filing follows two Complete Response Letters (CRLs). The first, issued in January 2025, cited Good Manufacturing Practice deficiencies at a third-party manufacturing facility and did not raise concerns over efficacy, safety, or trial design. After those manufacturing issues were resolved, the US FDA issued a second CRL in January 2026, saying the single-arm ALLELE study was not adequate to provide substantial evidence of effectiveness for accelerated approval and raising concerns over the interpretability of the trial.
The latest resubmission follows feedback from an April 2026 Type A meeting and includes an updated data package from the pivotal Phase III single-arm ALLELE study, with additional patients and longer follow-up, alongside supplemental data from expanded access programs, a separate clinical study, and commercial experience in Europe. A revised anticipated PDUFA date will be provided as it becomes available, the company said.
Tabelecleucel consists of donor-derived, EBV-specific cytotoxic T lymphocytes that recognize and eliminate EBV-infected cells driving lymphoproliferative disease; the therapy does not require T-cell receptor or HLA gene editing and can be delivered from pre-manufactured inventory.