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Amtagvi (lifileucel) – New orphan drug approval

February 16, 2024 - The FDA announced the approval of Iovance Biotherapeutics’ Amtagvi (lifileucel), 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.

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