Yescarta
axicabtagene ciloleucel
Table of contents
Overview
Yescarta is a medicine for treating two types of blood cancer:
- diffuse large B-cell lymphoma (DLBCL);
- primary mediastinal large B-cell lymphoma (PMBCL).
Yescarta is for adult patients whose blood cancer has returned or has stopped responding to previous treatment.
Yescarta is a type of advanced therapy medicine called a ‘gene therapy product’. This is a type of medicine that works by delivering genes into the body.
The blood cancers that Yescarta is used to treat are rare, and Yescarta was designated an ‘orphan medicine’ (a medicine used in rare diseases) for DLBCL on 16 December 2014 and for PMBCL on 9 October 2015.
Yescarta contains the active substance axicabtagene ciloleucel (consisting of genetically modified white blood cells).
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Yescarta : EPAR - Medicine overview (PDF/89.07 KB)
First published: 10/09/2018
Last updated: 10/09/2018 -
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Yescarta : EPAR - Risk-management-plan summary (PDF/276.27 KB)
First published: 10/09/2018
Last updated: 26/06/2020
Authorisation details
Product details | |
---|---|
Name |
Yescarta
|
Agency product number |
EMEA/H/C/004480
|
Active substance |
axicabtagene ciloleucel
|
International non-proprietary name (INN) or common name |
axicabtagene ciloleucel
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L01X
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Orphan |
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation. |
Publication details | |
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Marketing-authorisation holder |
Kite Pharma EU B.V.
|
Revision |
6
|
Date of issue of marketing authorisation valid throughout the European Union |
23/08/2018
|
Contact address |
Product information
22/06/2020 Yescarta - EMEA/H/C/004480 - IAIN/0023
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Yescarta is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.