Pierre Fabre Resubmits FDA BLA for Tabelecleucel in Rare Post-Transplant Cancer
Secaucus, N.J. – September 30, 2026 -- Pierre Fabre Pharmaceuticals Inc. (PFP) has resubmitted a Biologics License Application to the U.S. Food and Drug Administration for tabelecleucel, seeking approval as a monotherapy for adult and pediatric patients aged 2 and older with relapsed or refractory Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have failed at least one prior therapy.
Resubmission follows April 2026 FDA alignment meeting
PFP filed the updated application after reaching agreement with the FDA during an April 2026 Type A meeting. The package includes an expanded dataset with additional patients and longer follow-up from the pivotal Phase 3 ALLELE study, which evaluates tabelecleucel in patients with EBV+ PTLD following hematopoietic cell transplant (HCT) or solid organ transplant (SOT).