Pierre Fabre refiles tabelecleucel after agreeing on an FDA path forward

Pierre Fabre Pharmaceuticals has resubmitted its U.S. application for tabelecleucel, also known as Ebvallo, an investigational T-cell therapy for Epstein–Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD). The proposed use is for adults and children aged 2 and older whose disease has persisted or returned after at least one prior treatment.

The filing follows discussions with the FDA in April 2026. The agency agreed that the Phase 3 ALLELE single-arm study, assessed with an appropriate historical control specified in advance, could support the application—offering a path forward without starting a new trial.

The resubmission includes additional patients and longer follow-up from ALLELE, plus supporting evidence from expanded-access programs, another clinical study, and European commercial use.

The FDA had issued a complete response letter in January 2026. Although it acknowledged the earlier manufacturing deficiency was resolved, it said the existing clinical evidence was insufficient and requested a new study. The companies and FDA later aligned on a different evidentiary approach.

The application is not yet approved in the U.S. The FDA must first accept and review the resubmission; a decision date was not reported in the available coverage.