Brexucabtagene autoleucel

This medicine is authorised for use in the European Union.


Tecartus is a cancer medicine used to treat:

  • adults with mantle cell lymphoma (a cancer of B cells, a type of white blood cell) when the cancer has come back after two or more previous treatments, including a type of cancer medicine called a Bruton’s tyrosine kinase (BTK) inhibitor;
  • adults 26 years of age and older with acute lymphoblastic leukaemia (another cancer of B cells) when the cancer has come back or did not respond to previous treatments.

These type of B-cell cancers are rare, and Tecartus was designated an ‘orphan medicine’ (a medicine used in rare diseases) for mantle cell lymphoma on 13 November 2019 and for acute lymphoblastic leukaemia on 19 October 2020.

Tecartus contains the active substance brexucabtagene autoleucel, which consists of genetically modified white blood cells.

This EPAR was last updated on 28/11/2023

Authorisation details

Product details
Agency product number
Active substance
Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel)
International non-proprietary name (INN) or common name
Brexucabtagene autoleucel
Therapeutic area (MeSH)
Lymphoma, Mantle-Cell
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Conditional approvalConditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.


This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Kite Pharma EU B.V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Science Park 408
1098 XH Amsterdam

Product information

15/11/2023 Tecartus - EMEA/H/C/005102 - PSUSA/00010903/202301

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Mantle cell lymphoma
Tecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.

Acute lymphoblastic leukaemia
Tecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).

Assessment history

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