EU/3/20/2344: Orphan designation for the treatment of acute lymphoblastic leukaemia

Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured

Overview

On 19 October 2020, orphan designation EU/3/20/2344 was granted by the European Commission to Kite Pharma EU B.V., Netherlands, for autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (also known as KTE-X19) for the treatment of acute lymphoblastic leukaemia.

The sponsor’s address was updated in September 2021.

Key facts

Active substance
Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured
Intended use
Treatment of acute lymphoblastic leukaemia
Orphan designation status
Positive
EU designation number
EU/3/20/2344
Date of designation
19/10/2020
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 reviews the orphan designation of a product if it is approved for marketing authorisation.

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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