Lifileucel, sold under the brand name Amtagvi, is an adoptive T cell therapy used to treat melanoma, and is a personalized cancer immunotherapy made from a patient's own tumor-infiltrating lymphocytes. Tumor tissue is surgically removed, the patient's T cells that had infiltrated the tumor are isolated and expanded in a laboratory, and the expanded cells are reinfused as a single dose meant to strengthen the immune system's fight against the cancer. It is indicated for adults with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and, if the patient carries a BRAF V600 mutation, prior treatment with a BRAF inhibitor with or without a MEK inhibitor. It received FDA approval in February 2024, becoming the first tumor-derived T cell immunotherapy approved by the FDA.
Facts
Classification
Approval Status ATC ClassSourced to the subject's own accountL: Antineoplastic and Immunomodulating Agents 2 Route of Administration First Approved / Isolated Year Sources
1. Lifileucel (Wikipedia)
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It was approved for medical use in the United States in February 2024.
View the Source 2. Anatomical Therapeutic Chemical Classification System (Wikipedia)
WikipediaFirst-level anatomical group codes, Code LQuote, First-level anatomical group codes, Code L
Antineoplastic and immunomodulating agents
View the Source 3. Lifileucel (Wikipedia)
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Intravenous
View the Source 4. Drugs.com: Amtagvi (lifileucel) FDA Approval History
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Amtagvi (lifileucel) received FDA approval on February 16, 2024
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