Pierre Fabre Pharmaceuticals Announces Transfer from Atara Biotherapeutics of the Biologics License Application (BLA) for Tabelecleucel as Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD)

Core Insights - The article discusses the Biologics License Application (BLA) for tabelecleucel, which is currently under FDA Priority Review, potentially becoming the first approved therapy in the U.S. for EBV+ PTLD with a target action date of January 10, 2026 [1][2] - Tabelecleucel is an allogeneic T-cell therapy aimed at treating patients with EBV+ PTLD, a rare and severe blood malignancy with limited treatment options and poor prognosis [1][4] Company Developments - Pierre Fabre Pharmaceuticals has taken over the BLA for tabelecleucel from Atara Biotherapeutics, assuming full responsibility for clinical development, regulatory, commercial, and manufacturing activities worldwide [1][2] - Atara Biotherapeutics will continue to support Pierre Fabre during the regulatory process [1][2] Product Information - Tabelecleucel is designed as an off-the-shelf, EBV-specific T-cell immunotherapy that targets and eliminates EBV-infected cells, with data from over 430 patients included in the BLA [3][5] - The therapy is indicated for adult and pediatric patients aged two years and older with EBV+ PTLD who have received at least one prior therapy [1][3] Market Need - EBV+ PTLD is characterized by a median survival of only 3 weeks for HCT patients and 4.1 months for SOT patients after standard care fails, highlighting the urgent need for new therapeutic options [4]