EU/3/18/2018:

Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor (lisocabtagene maraleucel)

Overview

On 25 May 2018, orphan designation (EU/3/18/2017) 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 follicular 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)
Intented use
Treatment of follicular lymphoma
Date of designation
25/05/2018
Orphan designation status
Positive
EU designation number
EU/3/18/2018

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. +353 1 483 3857
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.

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