Tecartus

RSS

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

Authorised
This medicine is authorised for use in the European Union.

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).

This EPAR was last updated on 25/01/2021

Authorisation details

Product details
Name
Tecartus
Agency product number
EMEA/H/C/005102
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
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
Therapeutic area (MeSH)
Lymphoma, Mantle-Cell
Anatomical therapeutic chemical (ATC) code
L01X
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.

OrphanOrphan

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
14/12/2020
Contact address

Science Park 408
1098 XH Amsterdam
Netherlands

Product information

14/12/2020 Tecartus - EMEA/H/C/005102 -

Contents

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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.

Assessment history

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