brexucabtagene autoleucel
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: 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). This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). 1.1 Mantle Cell Lymphoma Adult patients with relapsed or refractory mantle cell lymphoma (MCL). This indication is approved under accelerated approval based on overall response rate and durability of response [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 1.2 Acute Lymphoblastic Leukemia Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).