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In this section: Approved Blood Products

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. 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).

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

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