FDA Accepts Resubmitted Application for EBV-Positive PTLD Treatment

The U.S. Food and Drug Administration has accepted the resubmitted Biologics License Application for tabelecleucel (Ebvallo; tab-cel), an allogeneic T-cell immunotherapy. This treatment is being evaluated for adults and children aged two and older with Epstein-Barr virus–positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received prior therapy. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of March 31, 2027, for a decision on this potential first-ever authorized treatment for this patient population.