Human medicines European public assessment report (EPAR): Tecartus, brexucabtagene autoleucel, Date of authorisation: 14/12/2020, Revision: 18, Status: Authorised

• Application under evaluation
• CHMP opinion
• European Commission decision

Overview

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.

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How is Tecartus used?

Tecartus can only be obtained with a prescription. It must be given to patients by trained doctors in specialist hospitals.

Tecartus is prepared using the patient’s own white blood cells which are extracted from the blood, genetically modified in the laboratory and then given back to the patient as a single infusion (drip) into a vein. Tecartus must only be given to the patient whose cells were used to make it.

Before receiving Tecartus, the patient should have a short course of chemotherapy to clear away their white blood cells, and just before the infusion the patient is given paracetamol and an antihistamine medicine to reduce the risk of reactions to the infusion.

A medicine called tocilizumab (or a suitable alternative if tocilizumab is unavailable due to a shortage), and emergency equipment must be available in case the patient has a potentially serious side effect called cytokine release syndrome (see risks section below).

Patients should be closely monitored for side effects for 10 days after treatment and are advised to stay close to a specialist hospital for at least 4 weeks after treatment.

For more information about using Tecartus, see the package leaflet or contact your doctor or pharmacist.

How does Tecartus work?

Tecartus contains brexucabtagene autoleucel, which consist of the patient’s own T cells (a type of white blood cell). These have been modified genetically in the laboratory, so that they make a protein called chimeric antigen receptor (CAR), which helps the T cells attach to a protein on the cancer cells called CD19.

When Tecartus is infused to the patient, the modified T cells can then attach to and kill the cancer cells, thereby helping to clear the cancer from the body.

What benefits of Tecartus have been shown in studies?

Mantle cell lymphoma (MCL)

A main study, which is currently ongoing, involved 74 adults with MCL whose cancer had come back after at least two previous treatments including a BTK inhibitor. Around 59% of patients (44 out of 74) treated with Tecartus had a complete response (which means they had no signs of the cancer left). This was better than results previously seen in similar patients given other treatments.

Acute lymphoblastic leukaemia (ALL)

In a main study involving 55 patients, Tecartus was shown to be effective in treating ALL that came back after or did not respond to previous treatments. After about 17 months of treatment, around 71% (39 out of 55) of patients had a complete response (no signs of cancer left) and 56% of all the patients (31 out of 55) had a complete response with their blood counts returning to normal.

What are the risks associated with Tecartus?

In the clinical study, serious side effects occurred in more than half of all patients. The most common serious side effects (which may affect more than 1 in 10 people) are cytokine release syndrome (a potentially life-threatening condition that can cause fever, vomiting, shortness of breath, pain and low blood pressure), encephalopathy (a brain disorder with headache, sleepiness and mental confusion) and infections.

Why is Tecartus authorised in the EU?

Patients with MCL and ALL have poor outcomes, particularly if the cancers come back or did not respond to previous treatments (such as a BTK inhibitor in patients with MCL). Tecartus provides a treatment option for these patients. Although serious side effects occur in most patients and can include cytokine release syndrome, these are manageable if the appropriate measures are in place (see below). The European Medicines Agency therefore decided that Tecartus’ benefits are greater than its risks and it can be authorised for use in the EU.

Tecartus has been given ‘conditional authorisation’. This means that there is more evidence to come about the medicine, which the company is required to provide. Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.

What information is still awaited for Tecartus?

Since Tecartus has been given a conditional authorisation, the company that markets the medicine will provide to the Agency the final reports of the currently ongoing study on MCL by 2025. The company should also carry out a study on the long-term effects and safety in women, the elderly and patients who are very ill with MCL.

To obtain more information on the long-term efficacy and safety of Tecartus in patients with ALL, the company will provide follow-up data from the ongoing study and will conduct an additional study involving patients with ALL.

What measures are being taken to ensure the safe and effective use of Tecartus?

The company that markets Tecartus must ensure that hospitals where Tecartus is given have appropriate expertise, facilities and training. Tocilizumab or a suitable alternative in case tocilizumab is unavailable due to a shortage must be available in case of cytokine release syndrome. The company must provide educational materials for healthcare professionals and patients about possible side effects of Tecartus, especially cytokine release syndrome.

The company must carry out several studies to obtain more information on Tecartus including its safety and effectiveness in the long term.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tecartus have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Tecartus are continuously monitored. Side effects reported with Tecartus are carefully evaluated and any necessary action taken to protect patients.

Other information about Tecartus

Tecartus received a conditional marketing authorisation valid throughout the EU on 14 December 2020.

Tecartus : EPAR - Medicine overview

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EMA/712397/2022

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Tecartus : EPAR - Risk management plan

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Product information

Tecartus : EPAR - Product information

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Latest procedure affecting product information:

VR/0000308229

23/04/2026

This medicine’s product information is available in all official EU languages. Select 'available languages' to access the language you need.

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Tecartus : EPAR - All authorised presentations

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Product details

Name of medicine

Tecartus

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

L01X

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).

Authorisation details

EMA product number

EMEA/H/C/005102

Additional 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.

Advanced therapy

This medicine is classified as an advanced therapy medicinal product (ATMP): a medicine for human use that is based on genes, tissues or cells. It offers groundbreaking new opportunities for the treatment of disease and injury. For more information, see Advanced therapy medicinal products: Overview.

Conditional 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.

Orphan

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.

PRIME: priority medicine

This medicine was granted entry to the EMA Priority Medicines (PRIME) scheme during its development. PRIME is a scheme launched by EMA to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier. For more information, see PRIME: priority medicines.

Marketing authorisation holder

Kite Pharma EU B.V.

Science Park 408 1098 XH Amsterdam Netherlands

Opinion adopted

15/10/2020

Marketing authorisation issued

14/12/2020

Revision

18

Assessment history

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Changes since initial authorisation of medicine

Tecartus : EPAR - Procedural steps taken and scientific information after authorisation

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02/06/2025

Last updated:

19/05/2026

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Tecartus : EPAR - Procedural steps taken and scientific information after authorisation (archive)

English (EN) (203.67 KB - PDF)

First published:

15/10/2021

Last updated:

20/11/2025

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Tecartus-PSUSA-00010903-202507 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number:

EMADOC-1700519818-3026217

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First published:

19/05/2026

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Tecartus-PSUSA-00010903-202501 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number:

EMADOC-1700519818-2426618

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First published:

20/11/2025

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Tecartus-H-C-PSUSA-00010903-202307 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number:

EMA/121570/2024

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First published:

24/04/2024

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Tecartus-H-C-PSUSA-00010903-202301 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number:

EMA/536113/2023

English (EN) (129.85 KB - PDF)

First published:

28/11/2023

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Tecartus : Orphan maintenance assessment report (post authorisation)

Adopted

Reference Number:

EMA/OD/0000063560

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First published:

02/12/2022

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Tecartus-H-C-005102-II-0008-G : EPAR - Assessment report - Variation

Adopted

Reference Number:

EMA/683619/2022

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First published:

02/12/2022

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CHMP post-authorisation summary of positive opinion for Tecartus (II-08-G)

Adopted

Reference Number:

EMA/CHMP/653247/2022

English (EN) (129.06 KB - PDF)

First published:

22/07/2022

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Initial marketing authorisation documents

Tecartus : EPAR - Public assessment report

Adopted

Reference Number:

EMA/588798/2020

English (EN) (4.54 MB - PDF)

First published:

25/01/2021

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Tecartus : Orphan maintenance assessment report (initial authorisation)

Adopted

Reference Number:

EMADOC-1700519818-577467

English (EN) (287.22 KB - PDF)

First published:

25/01/2021

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CHMP summary of positive opinion for Tecartus

Adopted

Reference Number:

EMA/CHMP/538747/2020

English (EN) (105.56 KB - PDF)

First published:

16/10/2020

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News on Tecartus

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2024

14/06/2024

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 July 2022

22/07/2022

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2020

16/10/2020

First CAR-T cell medicine for mantle cell lymphoma

16/10/2020

More information on Tecartus

• EMEA-001862-PIP01-15-M04 - paediatric investigation plan
• EU/3/19/2220 - orphan designation for treatment of mantle cell lymphoma
• EU/3/20/2344 - orphan designation for treatment of acute lymphoblastic leukaemia
• EMEA-001862-PIP03-20-M02 - paediatric investigation plan
• Abecma / Breyanzi / Carvykti / Kymriah / Tecartus / Yescarta - direct healthcare professional communication (DHPC)
• Fitness-for-Use Assessment across Four Data Sources for Real-World Safety and Effectiveness Studies of CAR-T cell therapies - post-authorisation study
• Identification, Characterisation, and Data Quality Assessment of Data Sources for Real-World Safety and Effectiveness Studies of Chimeric antigen receptor T-cell (CAR-T cell) therapies - post-authorisation study
• Molecular profiling of tissue samples from patients who received a Kite-manufactured gene-modified cell therapy and have developed a secondary malignancy of T-cell origin - post-authorisation study
• Long-term, Non-interventional Study of Recipients of Tecartus for Treatment of Adult Patients With Relapsed or Refractory (R/R) Mantle Cell Lymphoma (MCL) or Adult Patients With R/R B-Cell Precursor Acute Lymphoblastic Leukemia (ALL) - post-authorisation study
• Tecartus Survey: Quantitative Testing of Health Care Professional Knowledge About Tecartus® Risk Minimisation Measures - post-authorisation study

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