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🏅 FDA Orphan Designation

Aucatzyl

obecabtagene autoleucel

Manufacturer: Autolus Incorporated, US subsidiary of Autolus Limited

Indicated for:
Acute lymphoblastic leukemiaOrphanPrecursor T-cell acute lymphoblastic leukemia
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Black Box Warning (Boxed Warning)

A Boxed Warning is the FDA's strongest safety warning — it indicates serious or life-threatening risks identified during clinical trials or post-market surveillance. It does not mean the medication is unsafe for all patients; your prescriber weighs these risks against the benefits for your specific situation. Source: FDA-approved prescribing information.

View full prescribing information on DailyMed (NLM) ↗

FDA-Approved Indications (2)

treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)

AUCATZYL is indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)

Population: adults

Indications & Usage

1 INDICATION AND USAGE AUCATZYL is indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). AUCATZYL is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) ( 1 ).

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Aucatzyl
Autolus Incorporated, US subsidiary of Autolus Limited
Aucatzyl
Autolus Incorporated, US subsidiary of Autolus Limited

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Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.