On October 14, 2026 Pierre Fabre Pharmaceuticals Inc. (PFP) reported the acceptance by U.S. 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 two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy.
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"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," said Adriana Herrera, Chief Executive Officer of PFP, the Laboratoires Pierre Fabre Pharmaceutical subsidiary in the U.S. "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 two 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.
"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," said Melissa McQueen, President of Transplant Families, a pediatric non-profit connecting heart, liver, kidney, and bone marrow transplant patients and families. "We are hopeful that following the extensive dialogue with FDA, this resubmission will result in a path to patient access for U.S. families."
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 authorization under the brand name EBVALLO in December 2022 by the European Commission. Marketing authorization was also granted by the Medicines and Healthcare Products Regulatory Agency in the United Kingdom in May 2023 and by Swissmedic in Switzerland in May 2024. In the U.S., 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.
About EBV+PTLD
EBV+ PTLD is an ultra-rare, acute, and potentially deadly hematologic malignancy that occurs after transplantation when patient T-cell immune responses are compromised by immunosuppression. It can impact patients who have undergone SOT or allogeneic HCT. SOT patients have a life-long risk of contracting the disease. Poor median survival of 3 weeks and 4.1 months for HCT and SOT, respectively, is reported in EBV+ PTLD patients for whom initial treatment failed, underscoring the significant need for new therapeutic options.
(Press release, Pierre Fabre, OCT 14, 2026, View Source [SID1234673461])