EU/3/17/1890

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.

Key facts

Active substance
Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor
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

Celgene Europe B.V.
Winthontlaan 6 N
3526 KV Utrecht
The Netherlands
Tel. +31 302844547
E-mail: medinfo.intl@celgene.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;

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