Kymriah

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tisagenlecleucel

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

Overview

Kymriah is a medicine for treating two types of blood cancer:

  • B-cell acute lymphoblastic leukaemia (ALL), in children and young adults up to 25 years of age whose cancer did not respond to previous treatment, has come back two or more times, or has come back after a transplant of stem cells;
  • Diffuse large B-cell lymphoma (DLBCL) in adults whose cancer has come back or did not respond after two or more previous treatments.

Kymriah 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 Kymriah is used to treat are rare, and Kymriah was designated an ‘orphan medicine’ (a medicine used in rare diseases) for B-cell ALL on 29 April 2014 and DLBCL on 14 October 2016.

Kymriah contains the active substance tisagenlecleucel (consisting of genetically modified white blood cells).

This EPAR was last updated on 19/09/2018

Authorisation details

Product details
Name
Kymriah
Agency product number
EMEA/H/C/004090
Active substance
tisagenlecleucel
International non-proprietary name (INN) or common name
tisagenlecleucel
Therapeutic area (MeSH)
  • Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
Anatomical therapeutic chemical (ATC) code
L01
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.

OrphanOrphan

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
Novartis Europharm Limited
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
22/08/2018
Contact address

Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Product information

22/08/2018 Kymriah - EMEA/H/C/004090 - -

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Indicated for the treatment of:

  • Paediatric and young adult patients up to 25 years of age with B‑cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post‑transplant or in second or later relapse.
  • Adult patients with relapsed or refractory diffuse large B‑cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Assessment history

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