EU/3/15/1579: Orphan designation for the treatment of follicular lymphoma

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

Overview

This medicine is now known as axicabtagene ciloleucel. 

On 11 November 2015, orphan designation (EU/3/15/1579) 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 follicular lymphoma.

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

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)
Intended use
Treatment of follicular lymphoma
Orphan designation status
Positive
EU designation number
EU/3/15/1579
Date of designation
11/11/2015
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 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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