Medicine:Lifileucel
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 (autologous). 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 recipient in a single dose.[3] T cells are a type of cell that helps the immune system fight cancer and infections.[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 the first tumor-derived T cell immunotherapy approved by the US Food and Drug Administration.[3] It was approved for medical use in the United States in February 2024.[2][4]
Medical uses
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 a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.[1][3]
Side effects
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]
People treated with lifileucel may exhibit prolonged severe low blood count, severe infection, cardiac disorder, or develop worsened respiratory or renal function or have fatal treatment-related complications.[3] A boxed warning is included in the prescribing informationl containing information about these risks.[3]
History
The safety and effectiveness of lifileucel was evaluated in a global, multi-center, multi-cohort, 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
Legal status
Lifileucel was approved for medical use in the United States in February 2024.[2][4][5][6]
Names
Lifileucel is the international nonproprietary name.[7]
Lifileucel is sold under the brand name Amtagvi.[2]
Research
The clinical trials for lifileucel in melanoma include two phases. Phase II (178 participants) demonstrated the therapy's efficacy and durable response in participants with unresectable or metastatic melanoma who had failed PD-1 blockers and BRAF inhibitors. However, adverse effects were statistically significant.[8] Phase III (670 participants) aims to compare lifileucel combined with pembrolizumab for advanced melanoma stages (IIIC, IIID, or IV). Results are expected by 2028 and full completion by 2030.[9]
References
- ↑ 1.0 1.1 Cite error: Invalid
<ref>tag; no text was provided for refs namedAmtagvi FDA label - ↑ 2.0 2.1 2.2 2.3 "Amtagvi". U.S. Food and Drug Administration (FDA). 16 February 2024. https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/amtagvi.
This article incorporates text from this source, which is in the public domain.
- ↑ 3.00 3.01 3.02 3.03 3.04 3.05 3.06 3.07 3.08 3.09 3.10 3.11 3.12 "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.
- ↑ 4.0 4.1 "FDA grants accelerated approval to lifileucel for unresectable or metastatic melanoma". 16 February 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-lifileucel-unresectable-or-metastatic-melanoma.
- ↑ "Cancer Accelerated Approvals". 1 October 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals.
- ↑ "Iovance's Amtagvi (lifileucel) Receives U.S. FDA Accelerated Approval for Advanced Melanoma" (Press release). Iovance Biotherapeutics. 16 February 2024. Archived from the original on 18 February 2024. Retrieved 18 February 2024 – via GlobeNewswire.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 80". WHO Drug Information 32 (3). 2018.
- ↑ "Lifileucel, a Tumor-Infiltrating Lymphocyte Therapy, in Metastatic Melanoma". Journal of Clinical Oncology 39 (24): 2656–2666. August 2021. doi:10.1200/JCO.21.00612. PMID 33979178.
- ↑ "Life and death in peripheral T cells". Nature Reviews. Immunology 7 (7): 532–542. July 2007. doi:10.1038/nri2115. PMID 17589543.
This article incorporates public domain material from the United States Department of Health and Human Services document "US Food and Drug Administration".
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