EU/3/18/2099: Orphan designation for the treatment of primary mediastinal large B-cell lymphoma

Lisocabtagene maraleucel


On 19 November 2018, orphan designation (EU/3/18/2099) was granted by the European Commission to Celgene Europe Limited, United Kingdom, for lisocabtagene maraleucel for the treatment of primary mediastinal large B-cell lymphoma.

Please note that this product (marketed as  Breyanzi) was withdrawn from the Union Register of orphan medicinal products in February 2022 upon request of the marketing authorisation holder at the time of the granting of a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
Lisocabtagene maraleucel
Intended use
Treatment of primary mediastinal large B-cell lymphoma
Orphan designation status
EU designation number
Date of designation

Bristol-Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15
D15 T867
Tel. +353 1 483 3857

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

February 2022This product was withdrawn from the Union Register of orphan medicinal products on request of the Sponsor.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

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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