Kymriah

tisagenlecleucel · Novartis Europharm Limited
ORPHAN ADVANCED THERAPY PRIME AUTHORISED IN THE EU

What Kymriah is used for

Kymriah is indicated for the treatment of: • Paediatric and young adult patients up to and including 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. • Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

Approved use, as published by the European Medicines Agency.

What the labels mean

  • Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
  • Advanced therapy: a gene, cell or tissue-engineered medicine.
  • PRIME: a priority medicine that the EMA supported early because it may meet an unmet need.

Key facts

Brand
Kymriah
Active substance
tisagenlecleucel
Disease area
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Large B-Cell, Diffuse
Medicine group
Other antineoplastic agents
ATC code
L01XL04
Marketing authorisation holder
Novartis Europharm Limited
Authorised in the EU since
2018

Official information

Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.

Common questions

What is Kymriah used for?

Kymriah is indicated for the treatment of: • Paediatric and young adult patients up to and including 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. • Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

What is the active substance in Kymriah?

Kymriah contains tisagenlecleucel.

Who makes Kymriah?

The EU marketing authorisation holder is Novartis Europharm Limited.

Is Kymriah an orphan medicine?

Yes. Kymriah is designated an orphan medicine in the EU, for a rare disease (Precursor B-Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Large B-Cell, Diffuse).

Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.

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For information only, not medical advice. This page is a plain-language summary written from standard prescribing information and the public guides linked below. Brands sometimes change their formula, so always check the composition printed on the pack. Doses here are typical adult doses; yours may differ. Do not start, stop or change a medicine without your doctor or pharmacist, and keep all medicines away from children. In an emergency, call 112 (India) or your local emergency number.