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Obecabtagene autoleucel

FDA Drug Profile — AUCATZYL

Drug Details

Generic Name
Obecabtagene autoleucel
Brand Names
AUCATZYL
Application Number
BLA125813
Sponsor
Autolus Inc.
NDC Codes
1
Dosage Forms
KIT
Routes
N/A
Active Ingredients
N/A

Indications and 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 ).