Pierre Fabre Pharmaceuticals Announces Transfer from Atara Biotherapeutics of the Biologics License Application (BLA) for Tabelecleucel as Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD)
Pierre Fabre Pharmaceuticals (ATRA) announced it has taken over the U.S. Biologics License Application (BLA) for tabelecleucel from Atara Biotherapeutics, making Pierre Fabre responsible for global clinical development, regulatory, commercial, and manufacturing activities for the therapy.
The BLA is under FDA Priority Review with a PDUFA target action date of January 10, 2026. The submission covers more than 430 patients, and if approved tabelecleucel would be indicated as monotherapy for patients aged two years and older with EBV+ PTLD after at least one prior therapy. Manufacturing for global development and commercial access is being performed by Pierre Fabre in the U.S.
Pierre Fabre Pharmaceuticals (ATRA) ha annunciato di aver acquisito la domanda di licenza biologica statunitense (BLA) per tabelecleucel da Atara Biotherapeutics, rendendo Pierre Fabre responsabile dello sviluppo clinico globale, regolatorio, commerciale e delle attività di produzione per la terapia.
La BLA è in Priority Review FDA con una scadenza PDUFA prevista per il 10 gennaio 2026. La presentazione riguarda oltre 430 pazienti, e se approvata tabelecleucel sarebbe indicata come monoterapia per pazienti di età pari o superiore a due anni con EBV+ PTLD dopo almeno una terapia precedente. La produzione per lo sviluppo globale e l'accesso commerciale è gestita da Pierre Fabre negli Stati Uniti.
Pierre Fabre Pharmaceuticals (ATRA) anunció que ha adquirido la Solicitud de Licencia Biológica (BLA) de EE.UU. para tabelecleucel de Atara Biotherapeutics, haciendo que Pierre Fabre sea responsable del desarrollo clínico global, cumplimiento regulatorio, comercialización y actividades de fabricación para la terapia.
La BLA está bajo revisión prioritaria de la FDA Priority Review con una fecha objetivo de acción PDUFA del 10 de enero de 2026. La presentación cubre a más de 430 pacientes, y si se aprueba, tabelecleucel se indicaría como monoterapia para pacientes de dos años o más con EBV+ PTLD después de al menos una terapéutica previa. La fabricación para el desarrollo global y el acceso comercial está siendo realizada por Pierre Fabre en EE. UU.
피에르 파브르 제약(ATRA)은 Atara Biotherapeutics로부터 미국 생물학적 제형 허가 신청(BLA)을 인수했다고 발표했으며, 이로써 피에르 파브르는 이 치료제의 글로벌 임상 개발, 규제, 상업화 및 제조 활동을 책임지게 됩니다.
BLA는 FDA 우선 심사로 진행 중이며 PDUFA 목표 조치일 2026년 1월 10일입니다. 제출은 430명 이상의 환자를 포함하며, 승인되면 tabelecleucel은 최소 두 살 이상 EBV+ PTLD 환자에 대해 단일 요법으로 표시될 예정입니다. 글로벌 개발 및 상업적 접근을 위한 제조는 미국에서 피에르 파브르가 수행하고 있습니다.
Pierre Fabre Pharmaceuticals (ATRA) a annoncé avoir repris la demande de licence biologique (BLA) américaine pour tabelecleucel d'Atara Biotherapeutics, faisant de Pierre Fabre le responsable du développement clinique mondial, de la réglementation, des activités commerciales et de la fabrication pour cette thérapie.
La BLA est en révision prioritaire par la FDA avec une date cible d’action PDUFA du 10 janvier 2026. La soumission couvre plus de 430 patients, et si elle est approuvée, le tabelecleucel serait indiqué en monothérapie pour les patients âgés de deux ans et plus atteints de EBV+ PTLD après au moins une thérapie antérieure. La fabrication pour le développement global et l’accès commercial est assurée par Pierre Fabre aux États-Unis.
Pierre Fabre Pharmaceuticals (ATRA) hat die US-amerikanische Biologics License Application (BLA) für tabelecleucel von Atara Biotherapeutics übernommen und macht Pierre Fabre für die globale klinische Entwicklung, Regulierung, kommerzielle Tätigkeiten und Herstellung der Therapie verantwortlich.
Die BLA steht im FDA Priority Review mit einem PDUFA-Zieltermin am 10. Januar 2026. Die Einreichung umfasst mehr als 430 Patienten, und bei Genehmigung würde tabelecleucel als Monotherapie für Patienten ab zwei Jahren mit EBV+ PTLD indiziert sein, nach mindestens einer vorherigen Therapie. Die Herstellung für globale Entwicklung und kommerziellen Zugang erfolgt von Pierre Fabre in den USA.
Pierre Fabre Pharmaceuticals (ATRA) أعلنت أنها تولت ملف طلب ترخيص المستحضرات البيولوجية الأمريكية (BLA) لـ tabelecleucel من Atara Biotherapeutics، مما يجعل Pierre Fabre مسؤولة عن التطوير السريري العالمي والتنظيمي والتجاري وأنشطة التصنيع لهذه العلاج.
الـ BLA قيد مراجعة الأولوية من FDA مع تاريخ هدف إجراء-PDUFA في 10 يناير 2026. تغطي الطلبية أكثر من 430 مريضاً، وإذا تمت الموافقة فسيُشار إلى tabelecleucel كعلاج أحادي للمرضى الذين تبلغ أعمارهم سنتين فأكثر والذين يعانون من EBV+ PTLD بعد علاج واحد على الأقل. التصنيع من أجل التطوير العالمي والوصول التجاري يتم بواسطة Pierre Fabre في الولايات المتحدة.
- BLA transfer centralizes regulatory and commercial accountability under Pierre Fabre
- FDA Priority Review with a PDUFA date of Jan 10, 2026
- Clinical package includes data from more than 430 patients
- Regulatory approval is not yet granted; outcome pending the Jan 10, 2026 PDUFA decision
- Tabelecleucel remains investigational until FDA approval is issued
Insights
Transfer of the tabelecleucel BLA to Pierre Fabre and an FDA PDUFA date of
Pierre Fabre Pharmaceuticals now holds responsibility for the Biologics License Application and for global clinical, regulatory, commercial, and manufacturing activities for tabelecleucel, while Atara Biotherapeutics remains available as a support party. The BLA sits in Priority Review with a PDUFA target action date of
The business mechanism is straightforward: regulatory control and commercial readiness shifted to Pierre Fabre, which also manufactures the product in the U.S.; this concentrates execution risk and regulatory interactions with a single sponsor. Key dependencies include the FDA determination by the PDUFA date and the completeness and interpretability of the clinical dataset already filed. Material risks stem from regulatory questions, remaining data gaps, or labeling limitations that could affect the intended indication and patient access.
Watch the FDA decision on
Tabelecleucel BLA currently under
First allogeneic T-Cell therapy BLA offers hope to EBV+ PTLD patients who have limited treatment options and lifespan measured in only a few weeks to months following failure of initial treatment
EBV+ PTLD is an ultra-rare, acute, and potentially deadly blood malignancy that occurs after hematopoietic cell transplant (HCT) or solid organ transplant (SOT) when T-cell activity is impaired by immunosuppression
Pierre Fabre Laboratories and its subsidiaries are now responsible for all clinical development, regulatory, commercial, and manufacturing activities for tabelecleucel worldwide
Atara resubmitted the tabelecleucel BLA on July 11, 2025 of this year, in collaboration with PFP, and the FDA accepted the tabelecleucel BLA with Priority Review on July 23. With completion of the transfer of the BLA, Pierre Fabre Laboratories and its subsidiaries are now responsible for all clinical development regulatory, commercial and manufacturing activities for tabelecleucel worldwide. The innovative cell therapy is manufactured by PFP in the US for global clinical development and commercial access.
"Transfer of the BLA represents another critical milestone in our efforts to bring this innovative cell therapy to EBV+ PTLD patients in the US who have limited treatment options
and lifespan measured in only a few weeks to months following failure of initial treatment," said Adriana Herrera, chief executive officer of PFP, the Pierre Fabre Laboratories Pharmaceutical subsidiary in the
Tabelecleucel is an investigational, 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.
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 solid organ transplant (SOT) or allogeneic HCT. Poor median survival of 3 weeks and 4.1 months for HCT and SOT, respectively, is reported in EBV+ PTLD patients for whom standard of care failed, underscoring the significant need for new therapeutic options.
About Tabelecleucel
Tabelecleucel is an allogeneic, off-the-shelf, EBV-specific T-cell immunotherapy designed to selectively target and eliminate EBV-infected cells. Unlike autologous CAR-T therapies, allogeneic T-cells are derived from third-party donors and are not genetically modified. Immune cells are collected from the blood of healthy donors and exposed to Epstein-Barr virus antigens to enrich for T cells that recognize EBV. These EBV T cells are expanded, characterized, kept alive, and stored for future use in treating patients.
About Pierre Fabre Pharmaceuticals and Pierre Fabre Laboratories
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
The Pierre Fabre Laboratories 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 Pierre Fabre Laboratories, innovation is the lifeblood 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
For more information, visit www.pierrefabrepharmaceuticals.com, www.pierre-fabre.com, @Pierre Fabre Oncology.
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FAQ
What did Pierre Fabre announce about the tabelecleucel BLA for EBV+ PTLD (ATRA) on November 3, 2025?
When is the FDA PDUFA target action date for the tabelecleucel BLA (ATRA)?
What patient population would tabelecleucel treat if approved (ATRA)?
How much clinical data does the tabelecleucel BLA include (ATRA)?
Who will manufacture tabelecleucel for global clinical development and commercial access (ATRA)?
