Pierre Fabre Pharmaceuticals announced the strategic transfer of the Biologics License Application (BLA) for tabelecleucel, an investigational allogeneic EBV-specific T-cell therapy, from Atara Biotherapeutics. The FDA is currently reviewing the BLA under Priority Review, with a Prescription Drug User Fee Act (PDUFA) target action date set for January 10, 2026. If approved, tabelecleucel would become the first such therapy available in the U.S. for adult and pediatric patients aged two years and older with Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy.
This transfer marks a significant milestone for Pierre Fabre, which now assumes worldwide responsibility over all clinical development, regulatory, commercial, and manufacturing aspects of tabelecleucel. EBV+ PTLD is described as an ultra-rare and aggressive blood malignancy arising after hematopoietic cell or solid organ transplantation, with patients facing extremely limited treatment options and a prognosis sometimes measured only in weeks to months following failure of initial therapies.
The BLA submission includes data covering more than 430 patients across pivotal studies, including the ongoing ALLELE trial. Pierre Fabre’s leadership in advancing tabelecleucel underscores an urgent commitment to address critical unmet medical needs for the transplant population facing EBV+ PTLD.
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