EU/3/14/1393: Orphan designation for the treatment of diffuse large B-cell lymphoma
Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3 zeta chimeric antigen receptor (axicabtagene ciloleucel)
Table of contents
Overview
On 16 December 2014, orphan designation (EU/3/14/1393) 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 diffuse large B‑cell lymphoma.
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 diffuse large B cell lymphoma has been authorised in the EU as Yescarta since 23 August 2018.
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 diffuse large B-cell lymphoma
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/14/1393
|
Date of designation |
16/12/2014
|
Sponsor |
Kite Pharma EU B.V. |
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
orphan medicine assessment report
.
Update history
Date | Update |
---|---|
September 2021 | The sponsor's address was updated. |
April 2017 | The sponsorship was transferred to Kite Pharma EU B.V., Netherlands. |
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: