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)
Table of contents
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 medicinal product has been authorised in the EU as Yescarta since 21 June 2022.
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. |
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
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
orphan medicine assessment report
.
Update history
Date | Update |
---|---|
September 2021 | The sponsor's address was updated in September 2021 |
April 2017 | The sponsorship was transferred to Kite Pharma EU B.V., Netherlands, in April 2017. |
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: