This brand name is authorized in United States. It is also authorized in Austria, Estonia, Lithuania.
The drug AUCATZYL contains one active pharmaceutical ingredient (API):
1
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UNII
760HJB0YRD - OBECABTAGENE AUTOLEUCEL
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Obecabtagene autoleucel is an autologous immunotherapy consisting of the patient's own T cells engineered to express a CAR that recognises CD19 on-target cells via the murine CAT13.1E10 hybridoma (CAT) binding domain. Engagement of anti-CD19 (CAT) CAR-positive T cells with CD19-expressed on-target cells, such as cancer cells and normal B cells, leads to activation of the anti-CD19 (CAT) CAR-positive T cells and downstream signalling through the CD3-zeta domain. Proliferation and persistence by the anti-CD19 (CAT) CAR-positive T cells following activation are enhanced by the presence of the 4-1BB co-stimulatory domain. This binding to CD19 results in anti-tumour activity and killing of CD19-expressing target cells. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| AUCATZYL Dispersion for infusion | MPI, EU: SmPC | European Medicines Agency (EU) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| L01XL12 | L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01X Other antineoplastic agents → L01XL Antineoplastic cell and gene therapy | |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| EE | Ravimiamet | 3126226 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1104261 |
| US | FDA, National Drug Code | 83047-410 |
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