First allogeneic T-Cell therapy BLA offers hope to EBV+ PTLD patients who have limited treatment options and lifespan measured in only a few weeks to months following failure of initial treatmentEBV+ PTLD is an ultra-rare, acute, and potentially deadly blood malignancy that occurs after hematopoietic cell transplant (HCT) or solid organ transplant (SOT) when T-cell activity is impaired by immunosuppressionTabelecleucel has a Prescription Drug User Fee Act (PDUFA) target action date of January 10, 2026 and w ...

Atara Biotherapeutics resubmitted the tabelecleucel Biologics License Application (BLA) to the U.S. Food and Drug Administration on July 11 Pierre Fabre Laboratories is now responsible for all global clinical trial activities for the tabelecleucel clinical program Enrollment is ongoing for pivotal, Phase 3 ALLELE Study (NCT03394365) investigating tabelecleucel in patients with EBV+PTLD in Solid Organ Transplant and Allogeneic Hematopoietic Cell Transplant after failure of standard therapy NCT04554914 also o ...