Pierre Fabre Resubmits Drug Application to FDA

Pierre Fabre Pharmaceuticals Inc. (PFP) has announced that the U.S. Food and Drug Administration (FDA) has accepted its resubmitted Biologics License Application (BLA) for tabelecleucel. The drug is being developed for the treatment of adult and pediatric patients aged two and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy.

The BLA resubmission follows a Type A meeting with the FDA in April 2026. It includes an updated dataset with additional patients and longer follow-up from the ongoing Phase 3 ALLELE study. The submission also incorporates supplemental data from expanded access programs and European commercial experience.

EBV+ PTLD is a rare and potentially fatal blood cancer that can occur after transplantation when a patient's T-cell immune response is impaired. If approved, tabelecleucel would be the first FDA-authorized treatment for EBV+ PTLD patients who have limited survival prospects, often measured in weeks to months after initial therapy failure.

Tabelecleucel, marketed as EBVALLO™ in Europe, the UK, and Switzerland, is still investigational in the U.S. Pierre Fabre Pharmaceuticals focuses on developing therapies for oncology and rare diseases.