AMTAGVI
STN: 125773
Proper Name: lifileucel
Trade Name: AMTAGVI
Manufacturer: Iovance Biotherapeutics, Inc.
Indication:
- 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.
Product Information
- Package Insert - AMTAGVI
- Demographic Subgroup Information – lifileucel
Refer to Section 8.1.2.5 and 8.1.2.6 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
Supporting Documents
- February 16, 2024 Approval Letter - AMTAGVI
- February 15, 2024 Summary Basis for Regulatory Action - AMTAGVI
- Approval History, Letters, Reviews, and Related Documents - AMTAGVI