Lifileucel
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| Trade names | Amtagvi |
| Other names | LN-144 |
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| Routes of administration | Intravenous |
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Lifileucel, sold under the brand name Amtagvi, is a cellular therapy used for the treatment of melanoma.[1][2][3]
The most common adverse reactions include chills, fever, fatigue, tachycardia (abnormally fast heart rate), diarrhea, febrile neutropenia (fever associated with a low level of certain white blood cells), edema (swelling due to buildup of fluid in body tissues), rash, hypotension, hair loss, infection, hypoxia (abnormally low oxygen levels in the body) and feeling short of breath.[3]
Lifileucel is a tumor-derived autologous T cell immunotherapy composed of a recipient's own T cells, a type of cell that helps the immune system fight cancer.[3] A portion of the recipient's tumor tissue is removed during a surgical procedure prior to treatment.[3] The recipient's T cells are separated from the tumor tissue, further manufactured and then returned to the same recipient as a single dose for infusion.[3] It is the first tumor-derived T cell immunotherapy approved by the US Food and Drug Administration (FDA).[3] Lifileucel was approved for medical use in the United States in February 2024.[2][4][5]
Medical uses[edit]
Lifileucel is indicated for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (spread to other parts of the body) melanoma previously treated with other therapies (a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor).[3]
History[edit]
The safety and effectiveness of lifileucel was evaluated in a global, multicenter, multicohort clinical study including adult participants with unresectable or metastatic melanoma who had previously been treated with at least one systemic therapy, including a PD-1 blocking antibody, and if positive for the BRAF V600 mutation, a BRAF inhibitor or BRAF inhibitor with an MEK inhibitor.[3] Effectiveness was established based on objective response rate to treatment and duration of response (measured from the date of confirmed initial objective response to the date of progression, death from any cause, starting a new anti-cancer treatment or discontinuation from follow-up, whichever came first).[3]
The FDA approved lifileucel through the accelerated approval pathway and granted the application orphan drug, regenerative medicine advanced therapy, fast track, and priority review designations.[3] The FDA granted the approval of Amtagvi to Iovance Biotherapeutics.[3]
Society and culture[edit]
Names[edit]
Lifileucel is the international nonproprietary name.[6]
References[edit]
- ^ a b "Amtagvi- lifileucel suspension". DailyMed. 28 February 2024. Archived from the original on 11 March 2024. Retrieved 11 March 2024.
- ^ a b c "Amtagvi". U.S. Food and Drug Administration (FDA). 16 February 2024. Archived from the original on 18 February 2024. Retrieved 18 February 2024.
This article incorporates text from this source, which is in the public domain.
- ^ a b c d e f g h i j k "FDA Approves First Cellular Therapy to Treat Patients with Unresectable or Metastatic Melanoma". U.S. Food and Drug Administration (Press release). 16 February 2024. Archived from the original on 17 February 2024. Retrieved 18 February 2024. This article incorporates text from this source, which is in the public domain.
- ^ "FDA grants accelerated approval to lifileucel for unresectable or metastatic melanoma". U.S. Food and Drug Administration (FDA). 16 February 2024. Archived from the original on 27 February 2024. Retrieved 27 February 2024.
- ^ "Iovance's Amtagvi (lifileucel) Receives U.S. FDA Accelerated Approval for Advanced Melanoma" (Press release). Iovance Biotherapeutics Inc. 16 February 2024. Archived from the original on 18 February 2024. Retrieved 18 February 2024 – via GlobeNewswire.
- ^ World Health Organization (2018). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 80". WHO Drug Information. 32 (3). hdl:10665/330907.
This article incorporates public domain material from US Food and Drug Administration. United States Department of Health and Human Services.
External links[edit]
- "Lifileucel". NCI Thesaurus.
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