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Tabelecleucel - Atara Biotherapeutics

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Drug Profile

Tabelecleucel - Atara Biotherapeutics

Alternative Names: Allogeneic Epstein Barrr virus specific cytotoxic T-lymphocytes - Atara/MSKCC; ATA-129; EBV targeted T-cell therapy - Atara/MSKCC; EBV-CTL - Atara/MSKCC; EBV-specific T-cells - Atara/MSKCC; Ebvallo; EbvalloTM; Epstein-Barr virus specific cytotoxic T-lymphocytes - Atara/MSKCC; Epstein-Barr virus-specific T-cell therapy - Atara Biotherapeutics/Memorial Sloan-Kettering Cancer Center; tab-cel

Latest Information Update: 22 Aug 2025

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At a glance

  • Originator Memorial Sloan-Kettering Cancer Center
  • Developer Atara Biotherapeutics
  • Class Antineoplastics; Gene therapies; Immunotherapies; T lymphocyte cell therapies
  • Mechanism of Action Immunologic cytotoxicity; T lymphocyte replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Lymphoproliferative disorders
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Lymphoproliferative disorders
  • Phase I/II Nasopharyngeal cancer

Most Recent Events

  • 11 Aug 2025 US FDA assigns Class 2 Resubmission PDUFA action date of 10/01/2026 for Tabelecleucel for Lymphoproliferative disorders (Monotherapy, In children, In adolescents, In adults, Second-line therapy or greater)
  • 24 Jul 2025 US FDA accepts BLA for Tabelecleucel for Lymphoproliferative disorders for review
  • 14 Jul 2025 Atara Biotherapeutics resubmits a Biologics License Application to the US FDA for tabelecleucel in Lymphoproliferative disorders

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