Tecartus

brexucabtagene autoleucel · Kite Pharma EU B.V.
ORPHAN ADVANCED THERAPY PRIME CONDITIONAL APPROVAL AUTHORISED IN THE EU

What Tecartus is used for

Mantle cell lymphoma Tecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. Acute lymphoblastic leukaemia Tecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).

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.
  • Conditional approval: approved on less complete data because the need is high; more data must follow.

Key facts

Brand
Tecartus
Active substance
brexucabtagene autoleucel
Disease area
Lymphoma, Mantle-Cell
Medicine group
Antineoplastic agents
ATC code
L01X
Marketing authorisation holder
Kite Pharma EU B.V.
Authorised in the EU since
2020

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 Tecartus used for?

Mantle cell lymphoma Tecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. Acute lymphoblastic leukaemia Tecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).

What is the active substance in Tecartus?

Tecartus contains brexucabtagene autoleucel.

Who makes Tecartus?

The EU marketing authorisation holder is Kite Pharma EU B.V..

Is Tecartus an orphan medicine?

Yes. Tecartus is designated an orphan medicine in the EU, for a rare disease (Lymphoma, Mantle-Cell).

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.