Yescarta

RSS

axicabtagene ciloleucel

Authorised
This medicine is authorised for use in the European Union.

Overview

An overview of Yescarta and why it is authorised in the EU

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).

This EPAR was last updated on 10/09/2018

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)
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
Anatomical therapeutic chemical (ATC) code
L01X
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
Marketing-authorisation holder
Kite Pharma EU B.V.
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
22/08/2018
Contact address
Science Park 408
1098 XH Amsterdam
The Netherlands

Product information

23/08/2018 Yescarta - EMEA/H/C/004480 - -

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.

Assessment history

How useful was this page?

Add your rating
Average
1 rating