EU/3/20/2344
Table of contents
About
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.
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
|
Disease / condition |
Treatment of acute lymphoblastic leukaemia
|
Date of first decision |
19/10/2020
|
Outcome |
Positive
|
EU designation number |
EU/3/20/2344
|
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
Sponsor's contact details
Kite Pharma EU B.V.
Science Park 408
1098 XH Amsterdam
The Netherlands
Tel. +31 2023 52630
E-mail: regulatory@kitepharma.com
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.