Drugs / tabelecleucel

Regulatory milestones approvals, filings & regulatory actions · 9 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed post-transplant lymphoproliferative disease 2 milestones
Filed US (FDA) — post-transplant lymphoproliferative disease 2026-09-30

“its partner, Pierre Fabre Pharmaceuticals, Inc. (PFP), has resubmitted the tabelecleucel Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA).” atarabio.com ↗

Rejected (CRL) US (FDA) Ebvallo post-transplant lymphoproliferative disease 2026-01-09

“the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the EBVALLO™ (tabelecleucel) Biologics License Application (BLA)” atarabio.com ↗

“submitted a briefing book to the FDA addressing the points from the Complete Response Letter dated January 9, 2026” atarabio.com ↗

“the Complete Response Letter (CRL) to the Biologics License Application (BLA) for tabelecleucel (tab-cel)” atarabio.com ↗

Approved Indication not stated 7 milestones
Filed US (FDA) EBVALLO Epstein-Barr virus positive post-transplant lymphoproliferative disease 2025-07-14

“the U.S. Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for tabelecleucel (tab-cel ® )” atarabio.com ↗

“resubmitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tabelecleucel (EBVALLO™ or tab-cel ® )” atarabio.com ↗

Clinical hold US (FDA) EBVALLO Epstein-Barr virus positive post-transplant lymphoproliferative disease 2025-01-21

“U.S. FDA issues clinical hold on EBVALLO ™ (tabelecleucel) and ATA3219 studies linked to EBVALLO Complete Response Letter (CRL)” atarabio.com ↗

Rejected (CRL) US (FDA) EBVALLO Epstein-Barr virus positive post-transplant lymphoproliferative disease 2025-01-16

“today announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the EBVALLO TM (tabelecleucel) Biologics License Application (BLA)” atarabio.com ↗

Filed US (FDA) — Epstein-Barr virus positive post-transplant lymphoproliferative disease 2024-07-17

“the U.S. Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for tabelecleucel (tab-cel ® )” atarabio.com ↗

Filed US (FDA) — Epstein-Barr virus positive post-transplant lymphoproliferative disease 2024-05-20

“Atara has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tabelecleucel (tab-cel ® )” atarabio.com ↗

Approved EU (EMA) Ebvallo — 2022-12-16 europa.eu ↗
Filed EU (EMA) — Epstein-Barr virus-positive post-transplant lymphoproliferative disease 2021-11-30

“the Marketing Authorization Application (MAA) for tabelecleucel (tab-cel ® ) has been fully validated by the European Medicines Agency (EMA).” atarabio.com ↗

Trials 8

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT03131934 May 2019 → Jun 2020 post-transplant lymphoproliferative disease University College, London Unknown No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT03769467 Feb 2019 → Aug 2021 Epstein-Barr virus infection, nasopharyngeal carcinoma Atara Biotherapeutics Terminated No outcome recorded
Phase 1/2 NCT00002663 Mar 1995 → Jul 2019 Epstein-Barr virus-related tumor, lymphoma, post-transplant lymphoproliferative disease Atara Biotherapeutics Completed No outcome recorded
Phase 22 trials
Phase 2 NCT04554914 Jul 2021 → Jun 2027 expected disease related to hematopoietic stem cell transplant, disease related to solid organ transplantation, immunodeficiency-associated lymphoproliferative disease, leiomyosarcoma +2 Pierre Fabre Laboratories Active not recruiting No outcome recorded
Phase 2 NCT01498484 Dec 2011 → Jul 2019 Epstein-Barr virus-associated lymphoproliferative disorder, post-transplant lymphoproliferative disease Atara Biotherapeutics Completed No outcome recorded
Phase 32 trials · 1 missed
Phase 3 NCT03394365 Dec 2017 → May 2030 expected disease related to hematopoietic stem cell transplant, disease related to solid organ transplantation, lymphoproliferative syndrome, post-transplant lymphoproliferative disease Pierre Fabre Laboratories Recruiting No outcome recorded
Phase 3 NCT02578641 Jul 2014 → Feb 2022 nasopharyngeal carcinoma Tessa Therapeutics Completed Missed primary
Phase not stated1 trial
— NCT02822495 — Epstein-Barr virus infection, Epstein-Barr virus-associated lymphoproliferative disorder, disease related to hematopoietic stem cell transplant, disease related to solid organ transplantation +6 Atara Biotherapeutics No longer available No outcome recorded

News releases announcing trial results or a regulatory action · 45

DateIssuerRelease
2026-05-07 Atara Biotherapeutics Regulatory Atara Biotherapeutics Provides Regulatory Update on Tabelecleucel atarabio.com ↗
The FDA agreed that a single arm study using an appropriate historical control applicable to the trial population, conducted in a pre-specified manner, could serve as an adequate and well controlled study and provide safety and efficacy data in support of a future marketing application of tab-cel for the proposed indication.
2026-03-12 Atara Biotherapeutics Regulatory Atara Biotherapeutics Provides Regulatory Update on Tabelecleucel atarabio.com ↗
2026-03-03 Atara Biotherapeutics Regulatory Atara Biotherapeutics Provides Regulatory Update on Tabelecleucel atarabio.com ↗
today announced that its partner Pierre Fabre Pharmaceuticals (PFP) has submitted a request to the FDA for a Type A meeting.
2026-01-12 Atara Biotherapeutics Regulatory Atara Biotherapeutics Provides Regulatory and Business Update on EBVALLO™ (tabelecleucel) atarabio.com ↗
The CRL indicates that the FDA is unable to approve the EBVALLO™ BLA in its present form.
2025-07-24 Atara Biotherapeutics Regulatory Atara Biotherapeutics Announces U.S. FDA Acceptance and Priority Review of the Biologics License Application for Tabelecleucel (Tab-cel®) for the Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease atarabio.com ↗
The BLA has been granted Priority Review with a Class 2 Resubmission Prescription Drug User Fee Act (PDUFA) target action date of January 10, 2026.
2025-07-14 Atara Biotherapeutics Regulatory Atara Biotherapeutics Provides Regulatory and Business Updates on Tabelecleucel (Tab-cel®) atarabio.com ↗
2025-05-05 Atara Biotherapeutics Regulatory Atara Biotherapeutics Provides Regulatory Updates on EBVALLO™ (tabelecleucel) atarabio.com ↗
2025-01-21 Atara Biotherapeutics Regulatory Atara Biotherapeutics Provides Update on Clinical Programs Related to EBVALLO™ (tabelecleucel) and ATA3219 atarabio.com ↗
U.S. FDA issues clinical hold on EBVALLO ™ (tabelecleucel) and ATA3219 studies linked to EBVALLO Complete Response Letter (CRL)
2025-01-16 Atara Biotherapeutics Regulatory Atara Biotherapeutics Provides Regulatory and Business Update on EBVALLO™ (tabelecleucel) atarabio.com ↗
The CRL was solely related to observations as part of a standard pre-license inspection of a third-party manufacturing facility for EBVALLO.
2024-07-17 Atara Biotherapeutics Regulatory Atara Biotherapeutics Announces U.S. FDA Acceptance and Priority Review of the Biologics License Application for Tabelecleucel (Tab-cel®) for the Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease atarabio.com ↗
2024-05-20 Atara Biotherapeutics Regulatory Atara Biotherapeutics Submits Tabelecleucel (Tab-cel®) Biologics License Application for Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease with U.S. FDA atarabio.com ↗
2024-01-31 Atara Biotherapeutics Results Atara Biotherapeutics and Pierre Fabre Laboratories Announce Publication of Phase 3 ALLELE Tab-cel® Data in The Lancet Oncology atarabio.com ↗
First Phase 3 Results Published for an Allogeneic T-Cell Therapy

All press releases naming this drug 55 releases

DateIssuerRelease

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 9 sources stand behind the page.

FieldValueCited text
Known as Tabelecleucel “receive IV infusion of tabelecleucel 2 × 10\^6 T-cells/kg” NCT01498484 ↗
5

“tabelecleucel (tab-cel®, ATA129), allogeneic EBV-CTLs” NCT00002663 ↗

NCT03769467 ↗

NCT02822495 ↗

NCT04554914 ↗

NCT03394365 ↗

Known as CNA12+ EBV CTL “An equal dose (10x7/m2) of CNA12+ EBV CTL and CNA8+ EBV CTL will be administered intravenously on day 0.” NCT03131934 ↗
Known as CNA8+ EBV CTL “An equal dose (10x7/m2) of CNA12+ EBV CTL and CNA8+ EBV CTL will be administered intravenously on day 0.” NCT03131934 ↗
Known as EBV-CTL “Epstein-Barr virus-specific cytotoxic T lymphocyte (EBV-CTL) is an autologous adoptive T-cell immunotherapy generated from the blood of individuals and manufactured without...” PMID 39241963 ↗ Sep 2024
Known as Epstein-Barr virus-specific cytotoxic T lymphocyte “Epstein-Barr virus-specific cytotoxic T lymphocyte (EBV-CTL) is an autologous adoptive T-cell immunotherapy generated from the blood of individuals and manufactured without...” PMID 39241963 ↗ Sep 2024
Known as tabelecleucel (tab-cel, ATA129), allogeneic EBV-CTLs “tabelecleucel (tab-cel®, ATA129), allogeneic EBV-CTLs” NCT00002663 ↗
Action Deplete “EBV-CTLs are cytotoxic T lymphocytes that specifically kill cells presenting EBV protein antigens including EBV-transformed B lymphocytes responsible for EBV-associated...” NCT00002663 ↗
Modality Cell therapy “Adoptive transfer of donor-derived EBV-specific cytotoxic T-lymphocytes (EBV-CTLs)” PMID 31689242 ↗ Feb 2020
Route Intravenous “will receive IV infusion of tabelecleucel (tab-cel)” NCT00002663 ↗