Tecartus
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
Table of contents
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). It is used 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.
Mantle cell lymphoma is rare, and Tecartus was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 13 November 2019.
The active substance in Tecartus consists of genetically modified white blood cells (called autologous anti-CD19-transduced CD3+ cells).
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Tecartus : EPAR - Medicine overview (PDF/152.96 KB)
First published: 25/01/2021
EMA/559947/2020 -
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Tecartus : EPAR - Risk-management-plan summary (PDF/1.1 MB)
First published: 25/01/2021
Authorisation details
Product details | |
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Name |
Tecartus
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Agency product number |
EMEA/H/C/005102
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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
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International non-proprietary name (INN) or common name |
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
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Therapeutic area (MeSH) |
Lymphoma, Mantle-Cell
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Anatomical therapeutic chemical (ATC) code |
L01X
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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. |
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. |
Publication details | |
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Marketing-authorisation holder |
Kite Pharma EU B.V.
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Date of issue of marketing authorisation valid throughout the European Union |
14/12/2020
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Contact address |
Product information
14/12/2020 Tecartus - EMEA/H/C/005102 -
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
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.