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
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 sponsor’s address was updated in September 2021.
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
|
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 reviews the orphan designation of a product if it is approved for marketing authorisation.
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: