lifileucel
lifileucel is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including AMTAGVI. Available dosage form: suspension.
Drug Details
- Generic Name
- lifileucel
- Brand Names
- AMTAGVI
- Application Number
- BLA125773
- Sponsor
- Iovance Biotherapeutics Inc.
- NDC Codes
- 1
- Dosage Forms
- SUSPENSION
- Routes
- INTRAVENOUS
- Active Ingredients
- LIFILEUCEL
Indications and Usage
1 INDICATIONS AND USAGE AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This indication is approved under accelerated approval based on objective response rate (ORR) [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This indication is approved under accelerated approval based on objective response rate (ORR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s) ( 1 )