EU/3/20/2344: Orphan designation for the treatment of acute lymphoblastic leukaemia
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)
Table of contents
Overview
On 19 October 2020, orphan designation EU/3/20/2344 was granted by the European Commission to Kite Pharma EU B.V., Netherlands, for 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 (also known as KTE-X19) for the treatment of acute lymphoblastic leukaemia.
The medicinal product (for treatment of acute lymphoblastic leukaemia) has been authorised in the EU as Tecartus since 2 September 2022.
Key facts
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)
|
Intended use |
Treatment of acute lymphoblastic leukaemia
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/20/2344
|
Date of designation |
19/10/2020
|
Sponsor |
Kite Pharma EU B.V. |
Review of designation
The Committee for Orphan Medicinal Products reviewed the orphan designation of Tecartus at the time of marketing authorisation, and confirmed that the orphan designation should be maintained. More information is available in the
orphan medicine assessment report
Update history
Date | Update |
---|---|
September 2021 | The sponsor’s address was updated in September 2021 |
Patients' organisations
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.
EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: