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.
This medicine is now known as lisocabtagene maraleucel.
Please note that this product (marketed as Breyanzi) was withdrawn from the Union Register of orphan medicinal products in February 2022 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.
Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor (lisocabtagene maraleucel)
Treatment of diffuse large B-cell lymphoma
|Orphan designation status||
|EU designation number||
|Date of designation||
Review of designation
The sponsor formally requested the withdrawal of the orphan designation prior to the Committee’s final opinion. More information is available in the withdrawal assessment report - orphan maintenance .
|February 2022||This product was withdrawn from the Union Register of orphan medicinal products on request of the Sponsor.|
|January 2021||The sponsorship was transferred to Bristol-Myers Squibb Pharma EEIG, Ireland|
|February 2019||The sponsorship was transferred to Celgene Europe B.V., the Netherlands|
Documents related to this orphan designation evaluation
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: