EU/3/17/1890
Table of contents
About
On 17 July 2017, orphan designation (EU/3/17/1890) was granted by the European Commission to Celgene Europe Limited, United Kingdom, for autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor (also known as JCAR017) for the treatment of diffuse large B-cell lymphoma.
The sponsorship was transferred to Celgene Europe B.V., the Netherlands, in February 2019.
The sponsorship was transferred to Bristol-Myers Squibb Pharma EEIG, Ireland in January 2021.
This medicine is now known as lisocabtagene maraleucel.
Key facts
Active substance |
Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor (lisocabtagene maraleucel)
|
Disease / condition |
Treatment of diffuse large B-cell lymphoma
|
Date of first decision |
17/07/2017
|
Outcome |
Positive
|
EU designation number |
EU/3/17/1890
|
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
Bristol-Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15
D15 T867
Ireland
Tel. +44 (0) 208 831 8327
E-mail: medical.information@bms.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.