Pierre Fabre Pharmaceuticals (PFP) has announced the acceptance by US Food and Drug Administration (FDA) of the Biologics License Application (BLA) resubmission for tabelecleucel, with a proposed indication as monotherapy for 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 one prior therapy.

Adriana Herrera, Chief Executive Officer, PFP, the Laboratoires Pierre Fabre Pharmaceutical subsidiary in the US, said, "People diagnosed with relapsed or refractory EBV+ PTLD urgently need new treatment options as they have no approved FDA therapies, and after failure of initial treatment their survival is limited, measured in only weeks to months. We look forward to a collaborative review process focused on the growing body of evidence supporting tabelecleucel approval including more patients and increased follow-up within our pivotal study and extensive supplemental data primarily from our ongoing early access programs and commercial experience in Europe."

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 SOT or HCT. The resubmission also includes additional supplemental data from expanded access programs, a separate clinical study, and commercial experience in Europe.

Melissa McQueen, President, Transplant Families, said, "When your child receives a transplant, you celebrate. You breathe again. You start to imagine a future, but then sometimes, the phone rings with news that no parent should ever have to hear: your child has cancer. We are hopeful that following the extensive dialogue with FDA, this resubmission will result in a path to patient access for US families."

Tabrecta 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. For eligible patients, it is available through clinical trials and expanded access programs.