axicabtagene ciloleucel

This medicine is authorised for use in the European Union.


Yescarta is a medicine for treating adults with certain types of blood cancer:

  • high-grade B-cell lymphoma (HGBL);
  • diffuse large B-cell lymphoma (DLBCL);
  • primary mediastinal large B-cell lymphoma (PMBCL);
  • follicular lymphoma (FL).

Yescarta is for use in patients whose blood cancer has returned (recurrent) or has stopped responding to previous treatment (refractory).

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, for PMBCL on 9 October 2015 and for FL on 11 November 2015.

Yescarta contains the active substance axicabtagene ciloleucel (consisting of genetically modified white blood cells).

This EPAR was last updated on 30/01/2023

Authorisation details

Product details
Agency product number
Active substance
Axicabtagene ciloleucel
International non-proprietary name (INN) or common name
axicabtagene ciloleucel
Therapeutic area (MeSH)
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional 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.


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
Marketing-authorisation holder
Kite Pharma EU B.V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Tufsteen 1
2132 NT Hoofddorp
The Netherlands

Product information

17/01/2023 Yescarta - EMEA/H/C/004480 - N/0058

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Yescarta is indicated for the treatment of adult patients with diffuse large B cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy.

Yescarta is indicated for the treatment of adult patients with relapsed or refractory (r/r) DLBCL and primary mediastinal large B cell lymphoma (PMBCL), after two or more lines of systemic therapy.

Yescarta is indicated for the treatment of adult patients with r/r follicular lymphoma (FL) after three or more lines of systemic therapy.

Assessment history

Changes since initial authorisation of medicine

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