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Drugs and Medicinal Substances

Lifileucel

Antineoplastic and Immunomodulating Agents

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
Approved 1
ATC ClassSourced to the subject's own account
L: Antineoplastic and Immunomodulating Agents 2
Route of Administration
Intravenous 3
First Approved / Isolated Year
2024 4
Sources
1. Lifileucel (Wikipedia)
lead sentence 8
Quote, lead sentence 8
It was approved for medical use in the United States in February 2024.
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2. Anatomical Therapeutic Chemical Classification System (Wikipedia)
WikipediaFirst-level anatomical group codes, Code L
Quote, First-level anatomical group codes, Code L
Antineoplastic and immunomodulating agents
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3. Lifileucel (Wikipedia)
WikipediaInfobox drug, routes_of_administration
Quote, Infobox drug, routes_of_administration
Intravenous
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4. Drugs.com: Amtagvi (lifileucel) FDA Approval History
FDA Approval History
Quote, FDA Approval History
Amtagvi (lifileucel) received FDA approval on February 16, 2024
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