Pierre Fabre Pharmaceuticals has resubmitted a biologics license application to the FDA for tabelecleucel, an investigational cell therapy for a rare cancer that can develop after transplantation.
The company is seeking approval to treat adults and children aged 2 and older with Epstein-Barr virus-positive post-transplant lymphoproliferative disease, or EBV-positive PTLD, who have received at least one prior therapy.
The resubmission follows an April 2026 meeting with the FDA. It includes updated results from ALLELE, an ongoing, single-arm Phase 3 study in patients whose disease returned or did not respond to treatment after a hematopoietic cell or solid organ transplant. The update adds patients and longer follow-up. Pierre Fabre also included data from expanded-access programs, a separate clinical study and European commercial use.
Tabelecleucel is an off-the-shelf T-cell therapy made from donor cells and designed to target cells infected with Epstein-Barr virus. It is sold as Ebvallo in the European Union, where it received authorization in December 2022. Regulators in the United Kingdom and Switzerland authorized it in May 2023 and May 2024, respectively. The therapy remains investigational in the United States.
EBV-positive PTLD is a rare blood cancer associated with weakened immune responses after transplantation. Pierre Fabre cited reported median survival after initial treatment failure of three weeks for patients who received a hematopoietic cell transplant and 4.1 months for those who received a solid organ transplant.
Pierre Fabre Pharmaceuticals is the U.S. subsidiary of Laboratoires Pierre Fabre Pharmaceutical. Its application asks the FDA to authorize tabelecleucel as a single-agent treatment for the specified patient group.
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