Aucatzyl

Opinion

EMA has issued an opinion on this medicine

obecabtagene autoleucel

Overview

On 22 May 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional¹ marketing authorisation for the medicinal product Aucatzyl², intended for the treatment of adults from 26 years of age with relapsed or refractory B cell precursor acute lymphoblastic leukaemia. 

As Aucatzyl is an advanced therapy medicinal product, the CHMP positive opinion is based on an assessment by the Committee for Advanced Therapies. The applicant for this medicinal product is Autolus GmbH.

Aucatzyl will be available as a 410 x 10⁶ cells dispersion for infusion. The active substance of Aucatzyl is obecabtagene autoleucel, an antineoplastic cell and gene therapy (ATC code: L01XL12). Aucatzyl is an autologous immunotherapy consisting of the patient’s own T cells engineered to express a chimeric antigen receptor that recognises and binds to CD19 on target cells. This results in activation of the immunological effect of the T-cell releasing inflammatory cytokines and chemokines, leading to killing of CD19-expressing cells.

The benefits of Aucatzyl are its ability to induce remission with a relevant duration in adults with relapsed or refractory acute lymphoblastic leukaemia, as seen in an open-label, multi-centre, single arm phase Ib/II study. The most common side effects with Aucatzyl include cytokine release syndrome, infections, musculoskeletal pain, pyrexia, pain, nausea, diarrhoea, headache, fatigue and haemorrhage.

The full indication is:

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).

Aucatzyl must be administered in a qualified treatment centre by a physician with experience in the treatment of haematological malignancies and trained for administration and management of patients treated with the medicinal product.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

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¹A conditional marketing authorisation is granted to a medicinal product that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. The marketing authorisation holder is expected to provide comprehensive clinical data at a later stage.

²This product was designated as an orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained

CHMP summary of positive opinion for Aucatzyl

AdoptedReference Number: EMA/CHMP/165911/2025

Product details

• Name of medicine:
  Aucatzyl
• Active substance:
  obecabtagene autoleucel
• International non-proprietary name (INN) or common name:
  obecabtagene autoleucel
• Therapeutic area (MeSH):
  Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
• Anatomical therapeutic chemical (ATC) code:
  L01XL
• EMA product number:
  EMEA/H/C/005907
• Conditional approval:

  This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

• Orphan:

  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.

• PRIME: priority medicine:

  This medicine was granted entry to the EMA Priority Medicines (PRIME) scheme during its development. PRIME is a scheme launched by EMA to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier. For more information, see PRIME: priority medicines.

• Marketing authorisation applicant:
  Autolus GmbH
• Opinion adopted:
  22/05/2025
• Opinion status:
  Positive