brexucabtagene autoleucel

FDA Drug Profile — TECARTUS

Drug Details

Generic Name
brexucabtagene autoleucel
Brand Names
TECARTUS
Application Number
BLA125703
Sponsor
Kite Pharma, Inc.
NDC Codes
2
Dosage Forms
SUSPENSION
Routes
INTRAVENOUS
Active Ingredients
BREXUCABTAGENE AUTOLEUCEL

Indications and Usage

1 INDICATIONS AND USAGE TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with relapsed or refractory mantle cell lymphoma (MCL). Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). 1.1 Mantle Cell Lymphoma TECARTUS is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). 1.2 Acute Lymphoblastic Leukemia TECARTUS is indicated for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).