Pierre Fabre Pharmaceuticals Takes Charge of Tabelecleucel for an EBV+ PTLD Treatment

Pierre Fabre Pharmaceuticals Takes Charge of Tabelecleucel for EBV+ PTLD Treatment

Pierre Fabre Pharmaceuticals Inc. (PFP) recently announced a significant advancement in the treatment landscape for patients suffering from Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD). The company has officially taken on the Biologics License Application (BLA) for Tabelecleucel, previously overseen by Atara Biotherapeutics. This transfer marks a crucial step in the journey to potentially offer the first FDA-approved treatment for this serious condition in the United States.

Initially, Tabelecleucel had its BLA submitted to the U.S. Food and Drug Administration (FDA) with a target action date set for January 10, 2026, following the acceptance of the application under priority review on July 23, 2025. For patients with limited treatment options and extremely short life expectancies, the approval of this therapy represents a beacon of hope. EBV+ PTLD is a rare, acute hematological malignancy that can arise after hematopoietic cell transplants (HCT) or solid organ transplants (SOT), particularly when T-cell functionality is compromised due to immunosuppressive treatments.

Adriana Herrera, CEO of PFP, emphasized the importance of this milestone. She noted, “The transfer of the BLA represents another critical milestone in our efforts to bring this innovative cell therapy to EBV+ PTLD patients in the U.S.” The urgency of this situation cannot be overstated, as poor median survival rates are reported for patients facing this dire diagnosis. For those who do not respond to initial treatments, the median survival is shockingly low, at just three to four months.

Tabelecleucel is classified as an allogeneic, off-the-shelf T-cell immunotherapy specifically designed to target and eradicate EBV-infected cells. During the BLA submission, data concerning over 430 patients treated with Tabelecleucel were included, showcasing its potential effectiveness. The ongoing pivotal ALLELE study further investigates the therapy's efficacy in both adults and pediatric patients who have experienced relapsed or refractory cases of EBV+ PTLD.

PFP has now become solely responsible for Tabelecleucel's clinical development, regulatory affairs, manufacturing processes, and commercial activities worldwide. The therapy is manufactured in the U.S. for both clinical development and commercial access, an important note considering the global reach of Pierre Fabre's operations. This company is regarded for its long-standing commitment to offering breakthrough therapies, particularly in oncology and rare diseases, where treatment options remain limited.

The support from Atara Biotherapeutics will continue as the company stays engaged in the regulatory process. This collaborative effort strengthens the commitment to advancing this therapy, underscoring the pivotal role that partnerships play within the pharmaceutical sector.

As PFP forges ahead, the company aims to engage thoroughly with the FDA to facilitate the review of Tabelecleucel BLA. The hope is to reshape survival outcomes for those diagnosed with EBV+ PTLD, a condition that severely impairs the immune system post-transplantation. The therapeutic regimen will be available for adult and pediatric patients aged two years and older who have undergone at least one prior treatment for this condition.

In summary, Pierre Fabre Pharmaceuticals is poised to make significant strides in treating EBV+ PTLD. With the transfer of the BLA, patients are one step closer to accessing a potentially life-saving treatment that leverages innovative immunotherapy technology. As the pharmaceutical company pushes forward with clinical trials and regulatory discussions, the landscape of treatment for EBV+ PTLD appears more promising than ever before.