Obecabtagene autoleucel

FDA Drug Profile — AUCATZYL

Obecabtagene autoleucel is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand name including AUCATZYL. Available dosage form: kit.

Drug Details

Generic Name
Obecabtagene autoleucel
Brand Names
AUCATZYL
Application Number
BLA125813
Sponsor
Autolus Inc.
NDC Codes
2
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 ).