Aucatzyl
obecabtagene autoleucel · Autolus GmbH
ADVANCED THERAPY PRIME CONDITIONAL APPROVAL AUTHORISED IN THE EUWhat Aucatzyl is used for
Aucatzyl is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B cell precursor acute lymphoblastic leukaemia (B ALL).
Approved use, as published by the European Medicines Agency.
What the labels mean
- 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
- Aucatzyl
- Active substance
- obecabtagene autoleucel
- Disease area
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
- Medicine group
- Antineoplastic agents
- ATC code
- L01XL
- Marketing authorisation holder
- Autolus GmbH
- Authorised in the EU since
- 2025
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 Aucatzyl used for?
Aucatzyl is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B cell precursor acute lymphoblastic leukaemia (B ALL).
What is the active substance in Aucatzyl?
Aucatzyl contains obecabtagene autoleucel.
Who makes Aucatzyl?
The EU marketing authorisation holder is Autolus GmbH.
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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