EU/3/15/1553: Orphan designation for the treatment of primary mediastinal large B-cell lymphoma

Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor (axicabtagene ciloleucel)

Overview

On 9 October 2015, orphan designation (EU/3/15/1553) was granted by the European Commission to Kite Pharma UK, Ltd, United Kingdom, for autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor for the treatment of primary mediastinal large B-cell lymphoma.

The sponsorship was transferred to Kite Pharma EU B.V., Netherlands, in April 2017.

This medicine is now known as axicabtagene ciloleucel.

Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3 zeta chimeric antigen receptor for treatment of primary mediastinal large B-cell lymphoma has been authorised in the EU as Yescarta since 23 August 2018.

The sponsor’s address was updated in September 2021.

Key facts

Active substance
Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor (axicabtagene ciloleucel)
Medicine name
Yescarta
Intended use
Treatment of primary mediastinal large B-cell lymphoma
Orphan designation status
Positive
EU designation number
EU/3/15/1553
Date of designation
09/10/2015
Sponsor

Kite Pharma EU B.V.
Tufsteen 1
2132 NT Hoofddorp
Noord-Holland
The Netherlands
Tel. +31 2023 52630
E-mail: regulatory@kitepharma.com

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Yescarta at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.

More information is available in the PDF icon orphan medicine assessment report .

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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