Tab-cel (tabelecleucel) / Atara, Pierre Fabre - LARVOL DELTA

Real-world experience with Tabelecleucel within and beyond the approval label. (PubMed, Blood Adv) - "Tabelecleucel (tab-cel) is an allogeneic Epstein-Barr-virus (EBV)-specific T-cell therapy approved in the European Union for relapsed or refractory (R/R) EBV-associated post-transplant lymphoproliferative disorder (PTLD) after rituximab or immunochemotherapy failure. Tab-cel shows efficacy and low toxicity in R/R PTLD/LPD in the vulnerable cohort of immunodeficient/transplanted patients. This real-world data helps elucidating optimal integration of tab-cel in the management of R/R PTLD."

Journal • Real-world evidence • Epstein-Barr Virus Infections • Solid Organ Transplantation • Transplantation

RELAPSED OR REFRACTORY POST-TRANSPLANT LYMPHOPROLIFERATIVE DISORDERS: REAL-LIFE MULTICENTER ITALIAN EXPERIENCE WITH TABELECLEUCEL (EBMT 2026) - "Sixteen patients (84.2%) received rituximab monotherapy as first line treatment. The preliminary Italian experience supports the efficacy and safety of tabelecleucel, consistent with the results of the ALLELE trial in SOT. In our cohort no response to tabelecleucel was observed in PTLD after HSCT, remarkably 3 of these patients did not meet ALLELE inclusion criteria. It is essential to identify early potential candidates for this promising new therapy, which is now readily accessible in our country."

Clinical • IO biomarker • Post-transplantation • Bone Marrow Transplantation • Diffuse Large B Cell Lymphoma • Epstein-Barr Virus Infections • Solid Organ Transplantation • Transplantation

REAL-WORLD EXPERIENCE WITH TABELECLEUCEL (EBMT 2026) - "Background: Tabelecleucel (Tab-cel) is an allogeneic Epstein–Barr virus (EBV)-specific T-cell therapy approved in the European Union for relapsed or refractory (R/R) EBV-associated post-transplant lymphoproliferative disorder (PTLD) after failure of rituximab or immunochemotherapy. Tab-cel demonstrates meaningful efficacy with a favorable safety profile in R/R PTLD/LPD within this highly vulnerable population of immunodeficient or transplanted patients. However, the durability of response depends on re-establishing effective immunosurveillance, and Tab-cel alone was not consistently sufficient to maintain long-term disease control. Future approaches should clarify how best to integrate Tab-cel into the therapeutic pathway for R/R LPD, potentially including optimized HLA matching to enhance antiviral activity and consideration of consolidation strategies following Tab-cel therapy."

Clinical • Real-world • Real-world evidence • Epstein-Barr Virus Infections • Solid Organ Transplantation

REAL-WORLD EXPERIENCE WITH TABELECLEUCEL (EBMT 2026) - "Background: Tabelecleucel (Tab-cel) is an allogeneic Epstein–Barr virus (EBV)-specific T-cell therapy approved in the European Union for relapsed or refractory (R/R) EBV-associated post-transplant lymphoproliferative disorder (PTLD) after failure of rituximab or immunochemotherapy. Tab-cel demonstrates meaningful efficacy with a favorable safety profile in R/R PTLD/LPD within this highly vulnerable population of immunodeficient or transplanted patients. However, the durability of response depends on re-establishing effective immunosurveillance, and Tab-cel alone was not consistently sufficient to maintain long-term disease control. Future approaches should clarify how best to integrate Tab-cel into the therapeutic pathway for R/R LPD, potentially including optimized HLA matching to enhance antiviral activity and consideration of consolidation strategies following Tab-cel therapy."

Clinical • Real-world • Real-world evidence • Epstein-Barr Virus Infections • Solid Organ Transplantation

RELAPSED OR REFRACTORY POST-TRANSPLANT LYMPHOPROLIFERATIVE DISORDERS: REAL-LIFE MULTICENTER ITALIAN EXPERIENCE WITH TABELECLEUCEL (EBMT 2026) - "Sixteen patients (84.2%) received rituximab monotherapy as first line treatment. The preliminary Italian experience supports the efficacy and safety of tabelecleucel, consistent with the results of the ALLELE trial in SOT. In our cohort no response to tabelecleucel was observed in PTLD after HSCT, remarkably 3 of these patients did not meet ALLELE inclusion criteria. It is essential to identify early potential candidates for this promising new therapy, which is now readily accessible in our country."

Clinical • IO biomarker • Post-transplantation • Bone Marrow Transplantation • Diffuse Large B Cell Lymphoma • Epstein-Barr Virus Infections • Solid Organ Transplantation • Transplantation

Pierre Fabre Pharmaceuticals Announces Type A Meeting Agreed with U.S. Food and Drug Administration (FDA) for Tabelecleucel Biologic License Application (BLA) (PRNewswire) - "The meeting will address the Complete Response Letter received by PFP from the agency on January 9, 2026. The company anticipates providing a regulatory update on the outcome of the meeting in the second quarter."

FDA event • Epstein-Barr Virus Infections • Post-Transplant Lymphoproliferative Disorders

ALLELE: A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy (clinicaltrials.gov) - P3 | N=66 | Recruiting | Sponsor: Pierre Fabre Medicament | Trial primary completion date: Aug 2025 ➔ May 2030

Trial primary completion date • Acute Lymphocytic Leukemia • Epstein-Barr Virus Infections • Solid Organ Transplantation • Transplantation

ALLELE: A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy (clinicaltrials.gov) - P3 | N=66 | Recruiting | Sponsor: Atara Biotherapeutics

New P3 trial • Acute Lymphocytic Leukemia • Epstein-Barr Virus Infections • Oncology • Solid Organ Transplantation • Transplantation

ALLELE: A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy (clinicaltrials.gov) - P3 | N=66 | Recruiting | Sponsor: Pierre Fabre Medicament | Trial completion date: Jun 2027 ➔ Aug 2030

Trial completion date • Acute Lymphocytic Leukemia • Epstein-Barr Virus Infections • Solid Organ Transplantation • Transplantation

ALLELE: A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy (clinicaltrials.gov) - P3 | N=115 | Recruiting | Sponsor: Pierre Fabre Medicament | N=66 ➔ 115

Enrollment change • Acute Lymphocytic Leukemia • Epstein-Barr Virus Infections • Solid Organ Transplantation • Transplantation

ALLELE: A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy (clinicaltrials.gov) - P3 | N=66 | Recruiting | Sponsor: Atara Biotherapeutics | Trial completion date: Nov 2020 ➔ Jun 2027 | Trial primary completion date: Nov 2020 ➔ Jun 2022

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Epstein-Barr Virus Infections • Solid Organ Transplantation • Transplantation

ALLELE: A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy (clinicaltrials.gov) - P3 | N=66 | Recruiting | Sponsor: Atara Biotherapeutics | Trial primary completion date: Jun 2022 ➔ Aug 2025

Trial primary completion date • Acute Lymphocytic Leukemia • Epstein-Barr Virus Infections • Solid Organ Transplantation • Transplantation

Pierre Fabre Pharmaceuticals Submits Type A Meeting Request to U.S. Food and Drug Administration (FDA) for Tabelecleucel Biologic License Application (BLA) (PRNewswire)

FDA event • Epstein-Barr Virus Infections • Post-Transplant Lymphoproliferative Disorders

Impact of Prior Treatment on the Efficacy of Tabelecleucel for Epstein–Barr Virus-Driven Posttransplant Lymphoproliferative Disease: Subgroup Analysis from the phase 3 Allele Study (TCT-ASTCT-CIBMTR 2026) - P3 | "Updated results confirm the clinical benefit of tabelecleucel with an ORR of 48.3% and 47.4%, in HCT and SOT recipients with R/R EBV+ PTLD, and a favorable ORR for SOT-R compared with SOT-RC. The safety profile was favorable with no new safety concerns. Explore a novel treatment for relapsed/refractory (R/R) Epstein–Barr virus-associated (EBV+) posttransplant lymphoproliferative disease (PTLD) To understand the longer-term clinical benefit of tabelecleucel as treatment for R/R EBV+ PTLD after standard-of-care therapy Evaluate treatment responses of HCT recipients who failed prior treatment with rituximab and SOT recipients who failed prior treatment with rituximab (SOT-R) or rituximab and chemotherapy (SOT- RC)"

Clinical • P3 data • Post-transplantation • Epstein-Barr Virus Infections • Graft versus Host Disease • Immunology • Solid Organ Transplantation • Transplant Rejection • Transplantation

Updated Clinical Results: A Multicenter, Open-Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Recipients with Epstein–Barr Virus-Driven Post Transplant Lymphoproliferative Disease after Failure of Rituximab or Rituximab Plus Chemotherapy (ASH 2024) - P3 | "The safety profile remains consistent with previous findings. These results represent a potential new treatment paradigm for pts with R/R EBV+ PTLD."

Clinical • P3 data • Post-transplantation • Bone Marrow Transplantation • Epstein-Barr Virus Infections • Graft versus Host Disease • Immunology • Infectious Disease • Solid Organ Transplantation • Transplantation

Tabelecleucel for allogeneic haematopoietic stem-cell or solid organ transplant recipients with Epstein-Barr virus-positive post-transplant lymphoproliferative disease after failure of rituximab or rituximab and chemotherapy (ALLELE): a phase 3, multicentre, open-label trial. (PubMed, Lancet Oncol) - P3 | "Tabelecleucel provides clinical benefit in patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disease, for whom there are no other approved therapies, without evidence of safety concerns seen with other adoptive T-cell therapies. These data represent a potentially transformative and accessible treatment advance for patients with relapsed or refractory disease with few treatment options."

IO biomarker • Journal • P3 data • Post-transplantation • Bone Marrow Transplantation • Epstein-Barr Virus Infections • Graft versus Host Disease • Immunology • Infectious Disease • Oncology • Rare Diseases • Solid Organ Transplantation • Transplantation

Multicenter, Open-Label, Phase 3 (P3) Study of Tabelecleucel (Tab-cel) for Solid Organ (SOT) or Allogeneic Hematopoietic Cell Transplant (HCT) Recipients with Epstein–Barr Virus-Driven Post Transplant Lymphoproliferative Disease (EBV+ PTLD) after Failure of Rituximab (R) or Rituximab and Chemotherapy (R + C) (ALLELE) (TCT-ASTCT-CIBMTR 2022) - P3 | "Conclusions : Tab-cel P3 interim data show clinically meaningful outcomes and promising ORR and OS in a pt population with poor survival and no approved therapies. Tab-cel was well tolerated without evidence of safety concerns typically observed with autologous chimeric antigen receptor cell therapies."

Clinical • IO biomarker • P3 data • Bone Marrow Transplantation • Epstein-Barr Virus Infections • Graft versus Host Disease • Immunology • Inflammation • Oncology • Rare Diseases • Transplantation

New and Updated Results from a Multicenter, Open-Label, Global Phase 3 (P3) Study of Tabelecleucel (Tab-cel) for Epstein–Barr Virus-Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) Following Allogeneic Hematopoietic Cell (HCT) or Solid Organ Transplant (SOT) after Failure of Rituximab (R) or Rituximab and Chemotherapy (R+CT) (ALLELE) (TCT-ASTCT-CIBMTR 2023) - P3 | "No fatal TEAEs, GvHD or organ rejection were reported as tab-cel related. Conclusions : Updated ALLELE P3 data, which included additional pts and longer follow-up, confirm that tab-cel provides consistent clinically meaningful outcomes, including improved overall ORR, prolonged DOR and OS, and no safety concerns seen with other adoptive T-cell therapies, making it a potentially transformative treatment advance for r/r EBV + PTLD."

Clinical • IO biomarker • P3 data • Post-transplantation • Diffuse Large B Cell Lymphoma • Epstein-Barr Virus Infections • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Rare Diseases • Solid Organ Transplantation • Transplantation

On January 9, 2026, Pierre Fabre Pharmaceuticals, Inc. received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) stating that the Agency is unable to approve the tabelecleucel Biologics License Application (BLA) in its present form (PRNewswire) - "The BLA was resubmitted following clear alignment with the FDA on the acceptability of the resubmission criteria and fulfillment of the conditions outlined in the January 15, 2025, CRL, which identified a single GMP-related deficiency and raised no concerns regarding safety, efficacy, or trial design....In the new CRL, despite acknowledging that the GMP issue had been resolved and raising no safety concerns, the FDA stated that it no longer considers the previously accepted single-arm ALLELE study to be adequate to support accelerated approval and requested a new study."

CRL • Epstein-Barr Virus Infections • Post-Transplant Lymphoproliferative Disorders

Subgroup analysis in pediatric patients from the Phase 3 study of tabelecleucel for allogeneic or solid organ transplant recipients with Epstein–Barr virus-driven post-transplant lymphoproliferative disease after failure of rituximab or rituximab and chemotherapy (ALLELE) (ASH 2025) - "This analysis of 12 pediatric patients from the ALLELE trial suggests that the risk/benefitprofile in the pediatric subgroup is consistent with that reported in the overall population, with an ORR of50% (6/12 patients) and 5/6 treatment responders still alive at data cutoff. These findings support the useof tabelecleucel in pediatric patients with R/R EBV+ PTLD who have historically poor survival and verylimited treatment options. The safety profile of tabelecleucel was favorable and no new concerns wereidentified for the pediatric population."

Clinical • P3 data • Post-transplantation • Epstein-Barr Virus Infections • Graft versus Host Disease • Immunology • Infectious Disease • Pediatrics • Solid Organ Transplantation • Transplant Rejection • Transplantation

Subgroup analysis based on prior treatment from the Phase 3 allele study of tabelecleucel for epstein-barr virus-driven post-transplant lymphoproliferative disease (ASH 2025) - P3 | "Here we present updated results from alarger number of patients (29 HCT, 57 SOT) focusing on a subgroup analysis based on prior treatment. Eligibility criteria required HCT patients to have failed prior treatment with rituximab, and SOTpatients to have failed prior treatment with rituximab (SOT-R) or rituximab and chemotherapy (SOT-RC).Patients received intravenous tabelecleucel at 2 x 106 cells/kg on days 1, 8, and 15 in 35-day cycles.Clinical and radiographic assessments were conducted toward the end of each cycle and treatmentresponse evaluated by independent oncologic response adjudication (IORA). Results from the ALLELE trial continue to demonstrate the efficacy of tabelecleucel with anORR of 48.3% in the HCT cohort and 47.4% in the SOT cohort. A favorable, but not a statistically significantORR for SOT-R compared with SOT-RC was observed. Overall, these findings represent a novel treatmentoption for patients with R/R EBV+ PTLD who have poor survival and no..."

P3 data • Post-transplantation • Epstein-Barr Virus Infections • Graft versus Host Disease • Immunology • Solid Organ Transplantation • Transplant Rejection • Transplantation

Pierre Fabre Pharmaceuticals Announces Updated Phase 3 Tabelecleucel Data at American Society of Hematology Meeting in Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) (PRNewswire) - "The updated findings showed patients receiving tabelecleucel had an objective response rate (ORR) of 47.7% with the HCT cohort achieving an 48.3% ORR and SOT cohort achieving a 47.4% ORR. The median (95% CI) overall survival (OS) from Kaplan-Meier survival estimates for the HCT cohort was 18.6 months. For the SOT cohort, median OS was not estimable as more than half of the patients remained in follow-up. In a sub-analysis of treatment response by prior therapy in SOT patients, ORR was 52.4% for those receiving rituximab and 44.4% for those receiving rituximab and chemotherapy."

P3 data • Epstein-Barr Virus Infections • Post-Transplant Lymphoproliferative Disorders

Tabelecleucel (tab-cel or Ebvallo) for Post-Transplant Lymphoproliferative Disease (PTLD) (Businesswire) - "Atara expects to receive an additional $40 million milestone payment from Pierre Fabre Laboratories contingent upon FDA approval of the tab-cel BLA."

Commercial • Epstein-Barr Virus Infections • Post-Transplant Lymphoproliferative Disorders

Successful treatment of EBV-positive lymphomatoid granulomatosis with tabelecleucel (DGHO 2025) - P2 | "Detailed data were obtained from electronic chart review, complemented by a mini-review of the literature.Results/Case description: Initial diagnosis was obtained by lung biopsy in 2017 and treated with rituximab (R) + CHOP chemoimmunotherapy, resulting in a metabolic complete remission. Tab-cel is currently being evaluated for other EBV-related diseases in a phase II basket trial (NCT04554914). Our report underscores the potential use of tab-cel for the treatment of LYG, contributing to the yet scarce experience on the use of immunotherapy in LYG."

Epstein-Barr Virus Infections • Hematological Malignancies • Lymphoma • T Cell Non-Hodgkin Lymphoma

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) (PRNewswire) - "The tabelecleucel BLA has an FDA PDUFA target action date of January 10, 2026....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."

FDA filing • PDUFA • Epstein-Barr Virus Infections • Post-Transplant Lymphoproliferative Disorders