Pierre Fabre Pharmaceuticals Resubmits Tabelecleucel Biologics License Application for Treatment of Epstein-Barr Virus Positive-Post-Transplant Lymphoproliferative Disease to the FDA

If approved, tabelecleucel will be the first FDA-authorized treatment for relapsed/refractory EBV+ PTLD patients whose survival is measured in only a few weeks to months following failure of initial therapy

SECAUCUS, N.J., Sept. 30, 2026 /PRNewswire/ -- Pierre Fabre Pharmaceuticals Inc. (PFP) announces the resubmission of the tabelecleucel Biologics License Application (BLA) to the U.S. 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 one prior therapy.

"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," said Adriana Herrera, Chief Executive Officer of PFP, the Laboratoires Pierre Fabre Pharmaceutical subsidiary in the U.S. "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 two years of age and older with relapsed/refractory EBV+ PTLD following hematopoietic cell transplant (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 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. It may be available to eligible patients 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.

About Pierre Fabre Pharmaceuticals and Laboratoires Pierre Fabre
The mission of PFP is to deliver breakthrough therapies in oncology and rare diseases to patient populations with high unmet needs and limited treatment options. Our belief is that every time we care for a single person, we make the whole world better.

PFP is the US pharmaceutical subsidiary of Laboratoires Pierre Fabre , a foundation-owned company with seven decades of impact. Laboratoires Pierre Fabre is a global healthcare company, established in 43 countries, with over 10,000 employees, and with products distributed in 120 territories across the globe.

The Laboratoires Pierre Fabre foundation ownership enhances the ability of the company to create long-term value for patients. Partnerships and acquisitions drive its innovative precision treatment pipeline and are enabled by the unique corporate structure.

Building on the legacy of Laboratoires Pierre Fabre , innovation is the life blood of PFP, and patient experience drives everything the company does. PFP aspires to design and develop therapeutic solutions inspired by patients and healthcare professionals; draw on science and nature as perpetual sources of inspiration; develop long-term partnerships with researchers and innovators worldwide; and place pharmaceutical ethics and climate transition at the heart of our action.

Pierre Fabre Pharmaceuticals has therapies in development for Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), NRAS-mutant melanoma, non-small cell lung cancer with mutation or amplification of MET, and X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED). Pierre Fabre Pharmaceuticals is headquartered in Secaucus, NJ.

For more information, visit www.pierrefabrepharmaceuticals.com, www.pierre-fabre.com, @Pierre Fabre Oncology. 

SOURCE Pierre Fabre Pharmaceuticals