Pierre Fabre Pharmaceuticals Inc. Announces FDA Acceptance and Priority Review of the Biologics License Application (BLA) for Tabelecleucel for the Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD)

On July 24, 2025 Pierre Fabre Pharmaceuticals Inc. (PFP) reported the acceptance by U.S. Food and Drug Administration (FDA) of the Biologics License Application (BLA) and Priority Review of tabelecleucel, indicated 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 (Press release, Pierre Fabre, JUL 24, 2025, View Source [SID1234654509]).

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Atara Biotherapeutics Inc. (Nasdaq: ATRA) resubmitted the tabelecleucel BLA on July 11, having in collaboration with PFP, swiftly addressed the third-party manufacturing facility observations outlined in the January 2025 Complete Response Letter.

"Patients diagnosed with relapsed or refractory EBV+ PTLD have no approved FDA treatment options, and following failure of initial therapy their survival is unfortunately measured in only weeks to months. Today’s BLA acceptance gives hope to these patients and is a significant step towards making this innovative cell therapy available in the United States," said Adriana Herrera, Chief Executive Officer of PFP, the Pierre Fabre Laboratories Pharmaceutical subsidiary in the U.S. "We are now completely focused on preparing for potential FDA approval of this innovative new treatment option."

Tabelecleucel is an allogeneic, off the shelf, EBV-specific T-cell immunotherapy which targets and eliminates EBV-infected cells. The BLA includes data covering more than 430 patients treated with tabelecleucel including the ongoing pivotal ALLELE study investigating the therapy in adults and children two years of age and older with relapsed or refractory EBV+ PTLD following SOT or HCT.

Tabelecleucel was granted marketing authorization under the brand name EBVALLO in December 2022 by the European Commission (EC). 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.

Since March 31, 2025, PFP has assumed global responsibility for tabelecleucel manufacturing of commercial product for European markets and for global clinical trial supply. On July 15, 2025, Atara Biotherapeutics transferred the tabelecleucel Investigational New Drug Application to Pierre Fabre Medicament, a subsidiary of Pierre Fabre Laboratories. As per the terms of the restated exclusive worldwide licensing agreement between Atara and Pierre Fabre Laboratories announced in November 2023, Atara is responsible for regulatory procedures up until BLA transfer to Pierre Fabre Pharmaceuticals.