French pharmaceutical company Pierre Fabre Pharmaceuticals Inc (PFP) announced on Thursday the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and granted Priority Review for tabelecleucel, indicated as monotherapy for treatment of adult and paediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy.

Atara Biotherapeutics Inc (Nasdaq:ATRA) resubmitted the tabelecleucel BLA on 11 July, having worked with PFP to swiftly address the third-party manufacturing facility observations outlined in the January 2025 Complete Response Letter.

PFP says that tabelecleucel is an allogeneic, off the shelf, EBV-specific T-cell immunotherapy which targets and eliminates EBV-infected cells. The BLA includes data covering more than 430 patients treated with tabelecleucel including the ongoing pivotal ALLELE study investigating the therapy in adults and children two years of age and older with relapsed or refractory EBV+ PTLD following solid organ transplant (SOT) or haematopoietic cell transplant (HCT).

Tabelecleucel was granted marketing authorisation under the brand name EBVALLO in December 2022 by the European Commission. Marketing authorisation was also granted by the Medicines and Healthcare Products Regulatory Agency in the United Kingdom in May 2023, and by Swissmedic in Switzerland in May 2024.