Pierre Fabre Pharmaceuticals has announced the resubmission of the tabelecleucel Biologics License Application (BLA) to the US Food and Drug Administration (FDA) with a proposed indication as monotherapy for the treatment of adult and pediatric patients 2 years of age and older with Epstein-Barr Virus-positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) who have received at least 1 prior therapy.

Adriana Herrera, Chief Executive Officer, PFP, the Laboratoires Pierre Fabre Pharmaceutical subsidiary in the US, said, "PFP remains committed to working with the FDA to advance treatment options for people living with EBV+ PTLD who after undergoing a potentially life-saving solid organ or Hematopoietic Cell Transplant suddenly face yet another life-threatening illness, cancer. These patients are waiting for an FDA-approved treatment as their survival after failure of initial therapy is measured in only weeks to a few months."

PFP resubmitted the BLA based on April 2026 Type A meeting alignment with the FDA. The submission includes an updated dataset with additional patients and longer follow up from the ongoing pivotal phase 3 single arm ALLELE study of tabelecleucel in adults and children 2 years of age and older with relapsed/refractory EBV+ PTLD following HCT or Solid Organ Transplant (SOT). The resubmission also includes additional supplemental data from expanded access programs, a separate clinical study, and commercial experience in Europe.

Tabelecleucel is an allogeneic, off the shelf, EBV-specific T-cell immunotherapy which is designed to target and attack EBV-infected cells. It was granted Marketing Authorisation (MA) under the brand name EBVALLO in December 2022 by the European Commission (EC). MA was also granted by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK in May 2023 and by Swissmedic in Switzerland in May 2024.

In the US, tabelecleucel is investigational and has not yet been approved by the FDA. It may be available to eligible patients through clinical trials and expanded access programs.