Core Perspective - The acceptance of the Biologics License Application (BLA) for tabelecleucel by the FDA represents a significant advancement for patients with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), who currently have limited treatment options and a very short lifespan following initial treatment failure [1][3] Group 1: Company Developments - Pierre Fabre Pharmaceuticals (PFP) has announced the acceptance of the BLA for tabelecleucel, which is targeted for FDA action by January 10, 2026, marking it as the first approved therapy in the U.S. for EBV+ PTLD [1] - Atara Biotherapeutics resubmitted the tabelecleucel BLA on July 11, 2025, after addressing manufacturing facility observations from a previous Complete Response Letter [2] - PFP has taken over global responsibility for tabelecleucel manufacturing for European markets and clinical trial supply since March 31, 2025, following a transfer of the Investigational New Drug Application from Atara Biotherapeutics [5] Group 2: Product Information - Tabelecleucel is an allogeneic, off-the-shelf, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells, with data from over 430 patients included in the BLA [3] - The therapy has already received marketing authorization in Europe under the brand name EBVALLO™ in December 2022, and in the UK and Switzerland in May 2023 and May 2024, respectively [4] Group 3: Industry Context - The mission of PFP is to provide breakthrough therapies in oncology and rare diseases, focusing on patient populations with high unmet needs [6] - Pierre Fabre Laboratories, the parent company of PFP, operates in 43 countries with over 10,000 employees and aims to create long-term value for patients through innovative partnerships and acquisitions [7]