Yescarta

axicabtagene ciloleucel

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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).

How is Yescarta used?

Yescarta is prepared using the patient’s own white blood cells which are extracted from the blood and genetically modified in the laboratory.

It is given as a single infusion (drip) into a vein and must only be given to the patient whose cells were used to make it. Before having Yescarta, the patient should have a short course of chemotherapy to clear away their existing white blood cells, and just before the infusion they are given paracetamol and an antihistamine medicine to reduce the risk of reactions to the infusion.

A medicine called tocilizumab and emergency equipment must be available in case the patient has a potentially serious side effect called cytokine release syndrome (see risks section below).

Patients should be closely monitored for 10 days after treatment for side effects and are advised to stay close to a specialist hospital for at least 4 weeks after treatment.

For more information about using Yescarta, see the package leaflet or contact your doctor or pharmacist.

How does Yescarta work?

Yescarta contains the patient’s own T cells (a type of white blood cell) that have been modified genetically in the laboratory so that they make a protein called chimeric antigen receptor (CAR). CAR can attach to another protein on the surface of cancer cells called CD19.

When Yescarta is given to the patient, the modified T cells attach to and kill cancer cells, thereby helping to clear the cancer from the body.

What benefits of Yescarta have been shown in studies?

A main study of 111 patients with DLBCL and PMBCL that was not responding to previous treatment or had returned showed that Yescarta is effective at clearing the cancer in many patients. Of the patients who joined the study, 47% had a complete response (which means they had no signs of the cancer left) and 66% had at least a partial response after treatment with Yescarta.

These results were better than those from studies of patients receiving standard cancer treatments, where around 7% of patients had a complete response and around 26% had at least a partial response.

What are the risks associated with Yescarta?

Serious side effects occur in more than 1 in 2 patients. The most common serious side effects are cytokine release syndrome (a potentially life-threatening condition that can cause fever, vomiting, shortness of breath, pain and low blood pressure), encephalopathy (a brain disorder caused associated with headache, somnolence and mental confusion) and infections.

For the full list of side effects and restrictions with Yescarta, see the package leaflet.

Why is Yescarta authorised in the EU?

A main study showed that Yescarta is effective at clearing the cancer in many patients with DLBCL and PMBCL that was not responding to previous treatment or had returned. The number of patients who were cleared of the cancer or had at least a partial response was higher than in patients receiving standard care.

Serious side effects, particularly cytokine release syndrome, can occur; however these are manageable if appropriate measures are in place (see below). The European Medicines Agency therefore decided that Yescarta’s benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Yescarta?

The company that markets Yescarta must ensure that hospitals where Yescarta is given have appropriate expertise, facilities and training. Tocilizumab must be available in case of cytokine release syndrome. The company must provide educational materials for healthcare professionals and patients about possible side effects, especially cytokine release syndrome.

The company must also carry out a study to obtain more information on the long term safety of Yescarta.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Yescarta have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Yescarta are continuously monitored. Side effects reported with Yescarta are carefully evaluated and any necessary action taken to protect patients.

Other information about Yescarta

Yescarta received a marketing authorisation valid throughout the EU on 23 August 2018.

Name Language First published Last updated
Yescarta : EPAR - Medicine overview BG = bălgarski 2018-09-10  
Yescarta : EPAR - Medicine overview ES = español 2018-09-10  
Yescarta : EPAR - Medicine overview CS = čeština 2018-09-10  
Yescarta : EPAR - Medicine overview DA = dansk 2018-09-10  
Yescarta : EPAR - Medicine overview DE = Deutsch 2018-09-10  
Yescarta : EPAR - Medicine overview ET = eesti keel 2018-09-10  
Yescarta : EPAR - Medicine overview EL = elliniká 2018-09-10  
Yescarta : EPAR - Medicine overview EN = English 2018-09-10  
Yescarta : EPAR - Medicine overview FR = français 2018-09-10  
Yescarta : EPAR - Medicine overview IT = italiano 2018-09-10  
Yescarta : EPAR - Medicine overview LV = latviešu valoda 2018-09-10  
Yescarta : EPAR - Medicine overview LT = lietuvių kalba 2018-09-10  
Yescarta : EPAR - Medicine overview HU = magyar 2018-09-10  
Yescarta : EPAR - Medicine overview MT = Malti 2018-09-10  
Yescarta : EPAR - Medicine overview NL = Nederlands 2018-09-10  
Yescarta : EPAR - Medicine overview PL = polski 2018-09-10  
Yescarta : EPAR - Medicine overview PT = português 2018-09-10  
Yescarta : EPAR - Medicine overview RO = română 2018-09-10  
Yescarta : EPAR - Medicine overview SK = slovenčina 2018-09-10  
Yescarta : EPAR - Medicine overview SL = slovenščina 2018-09-10  
Yescarta : EPAR - Medicine overview FI = suomi 2018-09-10  
Yescarta : EPAR - Medicine overview SV = svenska 2018-09-10  
Yescarta : EPAR - Medicine overview HR = Hrvatski 2018-09-10  
Name Language First published Last updated
Yescarta : EPAR - Risk-management-plan summary (English only) 2018-09-10  

This EPAR was last updated on 10/09/2018 .

Authorisation details

Product details

Product details for Yescarta
NameYescarta
Agency product numberEMEA/H/C/004480
Active substance

axicabtagene ciloleucel

International non-proprietary name (INN) or common name

axicabtagene ciloleucel

Therapeutic area Lymphoma, Large B-Cell, DiffuseLymphoma, Follicular
Anatomical therapeutic chemical (ATC) code L01X
Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Yescarta
Marketing-authorisation holder

Kite Pharma EU B.V.

Revision0
Date of issue of marketing authorisation valid throughout the European Union23/08/2018

Contact address:

Kite Pharma EU B.V.
Science Park 408 
1098 XH Amsterdam 
The Netherlands

Product information

Product information

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

Name Language First published Last updated
Yescarta : EPAR - Product Information EN = English 2018-09-10  
Yescarta : EPAR - Product Information EN = English 2018-09-10  
Yescarta : EPAR - Product Information EN = English 2018-09-10  
Yescarta : EPAR - Product Information EN = English 2018-09-10  
Yescarta : EPAR - Product Information EN = English 2018-09-10  
Yescarta : EPAR - Product Information EN = English 2018-09-10  
Yescarta : EPAR - Product Information EN = English 2018-09-10  
Yescarta : EPAR - Product Information EN = English 2018-09-10  
Yescarta : EPAR - Product Information EN = English 2018-09-10  
Yescarta : EPAR - Product Information EN = English 2018-09-10  
Yescarta : EPAR - Product Information EN = English 2018-09-10  
Yescarta : EPAR - Product Information EN = English 2018-09-10  
Yescarta : EPAR - Product Information EN = English 2018-09-10  
Yescarta : EPAR - Product Information EN = English 2018-09-10  
Yescarta : EPAR - Product Information EN = English 2018-09-10  
Yescarta : EPAR - Product Information EN = English 2018-09-10  
Yescarta : EPAR - Product Information EN = English 2018-09-10  
Yescarta : EPAR - Product Information EN = English 2018-09-10  
Yescarta : EPAR - Product Information EN = English 2018-09-10  
Yescarta : EPAR - Product Information EN = English 2018-09-10  
Yescarta : EPAR - Product Information EN = English 2018-09-10  
Yescarta : EPAR - Product Information EN = English 2018-09-10  
Yescarta : EPAR - Product Information EN = English 2018-09-10  
Yescarta : EPAR - Product Information EN = English 2018-09-10  
Yescarta : EPAR - Product Information EN = English 2018-09-10  

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.


Name Language First published Last updated
Yescarta : EPAR - All Authorised presentations EN = English 2018-09-10  
Yescarta : EPAR - All Authorised presentations EN = English 2018-09-10  
Yescarta : EPAR - All Authorised presentations EN = English 2018-09-10  
Yescarta : EPAR - All Authorised presentations EN = English 2018-09-10  
Yescarta : EPAR - All Authorised presentations EN = English 2018-09-10  
Yescarta : EPAR - All Authorised presentations EN = English 2018-09-10  
Yescarta : EPAR - All Authorised presentations EN = English 2018-09-10  
Yescarta : EPAR - All Authorised presentations EN = English 2018-09-10  
Yescarta : EPAR - All Authorised presentations EN = English 2018-09-10  
Yescarta : EPAR - All Authorised presentations EN = English 2018-09-10  
Yescarta : EPAR - All Authorised presentations EN = English 2018-09-10  
Yescarta : EPAR - All Authorised presentations EN = English 2018-09-10  
Yescarta : EPAR - All Authorised presentations EN = English 2018-09-10  
Yescarta : EPAR - All Authorised presentations EN = English 2018-09-10  
Yescarta : EPAR - All Authorised presentations EN = English 2018-09-10  
Yescarta : EPAR - All Authorised presentations EN = English 2018-09-10  
Yescarta : EPAR - All Authorised presentations EN = English 2018-09-10  
Yescarta : EPAR - All Authorised presentations EN = English 2018-09-10  
Yescarta : EPAR - All Authorised presentations EN = English 2018-09-10  
Yescarta : EPAR - All Authorised presentations EN = English 2018-09-10  
Yescarta : EPAR - All Authorised presentations EN = English 2018-09-10  
Yescarta : EPAR - All Authorised presentations EN = English 2018-09-10  
Yescarta : EPAR - All Authorised presentations EN = English 2018-09-10  
Yescarta : EPAR - All Authorised presentations EN = English 2018-09-10  
Yescarta : EPAR - All Authorised presentations EN = English 2018-09-10  

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

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Yescarta : Orphan maintenance assessment report EN = English 2018-09-10  
Yescarta : EPAR - Public assessment report EN = English 2018-09-10  
CHMP summary of positive opinion for Yescarta EN = English 2018-06-29