Lifileucel
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|---|---|
| Trade names | Amtagvi |
| Other names | LN-144 |
| AHFS/Drugs.com | Monograph |
| License data |
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| Routes of administration | Intravenous |
| Drug class | Antineoplastic |
| ATC code | |
| Legal status | |
| Legal status | |
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Lifileucel, sold under the brand name Amtagvi, is an adoptive T cell therapy used for the treatment of melanoma.[1][2][3]
Specifically, lifileucel is a tumor-derived T cell immunotherapy composed of a recipient's own T cells. A portion of the recipient's tumor tissue is removed during a surgical procedure prior to treatment.[3] The recipient's T cells (the tumor-infiltrating lymphocytes) are separated from the tumor tissue, multiplied and then infused into the patient in a single dose.[3] T cells are a type of cell that helps the immune system fight cancer and infections.[3]
Lifileucel is the first tumor-derived T cell immunotherapy approved by the US Food and Drug Administration (FDA).[3] It was approved for medical use in the United States in February 2024.[2][4]
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]
Side effects
[edit]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]
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 measured via the 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 US Food and Drug Administration (FDA) approved Lifileucel through the accelerated approval pathway and granted the application orphan drug, regenerative medicine advanced therapy, fast track, and priority review designations under the brand name Amtagvi to Iovance Biotherapeutics.[3]
Society and culture
[edit]Legal status
[edit]Lifileucel was approved for medical use in the United States in February 2024.[2][4][5][6]
Names
[edit]Lifileucel is the international nonproprietary name.[7]
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 d "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 "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.
- ^ a b "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.
- ^ "Cancer Accelerated Approvals". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 6 December 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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