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These highlights do not include all the information needed to use AMTAGVI safely and effectively. See full prescribing information for AMTAGVI. AMTAGVI (lifileucel) suspension for intravenous infusion Initial U.S. Approval: 2024
Medication labelWhy this: Advisory · dailymed-other
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).
- generic_name
- lifileucel
- product_names
- lifileucel
- ndc
- 73776-001, 73776-001-11, 73776-001-12
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en