EU/3/17/1890: Orphan designation for the treatment of diffuse large B-cell lymphoma

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

Overview

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Please note that this product (marketed as Breyanzi) was withdrawn from the Union Register of orphan medicinal products in February 2022 upon request of the marketing authorisation holder at the time of the granting of a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.

Key facts

Active substance
Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor (lisocabtagene maraleucel)
Intended use
Treatment of diffuse large B-cell lymphoma
Orphan designation status
Withdrawn
EU designation number
EU/3/17/1890
Date of designation
17/07/2017
Sponsor

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

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of product at the time of marketing authorisation.

The sponsor formally requested the withdrawal of the orphan designation prior to the Committee’s final opinion. More information is available in the PDF icon withdrawal assessment report - orphan maintenance .

Update history

DateUpdate
February 2022This product was withdrawn from the Union Register of orphan medicinal products on request of the Sponsor.
January 2021The sponsorship was transferred to Bristol-Myers Squibb Pharma EEIG, Ireland
February 2019The sponsorship was transferred to Celgene Europe B.V., the Netherlands

Documents related to this orphan designation evaluation

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.

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:

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