Identification
- Summary
Lifileucel is an autologous T cell immunotherapy used to treat unresectable or metastatic melanoma in previously treated adults.
- Brand Names
- Amtagvi
- Generic Name
- Lifileucel
- DrugBank Accession Number
- DB17107
- Background
Lifileucel is a tumour-derived autologous T cell immunotherapy composed of a suspension of tumour-derived T cells from the patient 3 which undergo isolation, ex vivo expansion, and activation2 Lifileucel was granted accelerated approval by the FDA on February 16, 2024, for the treatment of unresectable or metastatic melanoma.4
- Type
- Biotech
- Groups
- Approved, Investigational
- Biologic Classification
- Cell transplant therapies
Autologous cell transplant - Synonyms
- Autologous tumor infiltrating lymphocytes
- Lifileucel
- Tumor infiltrating lymphocytes, autologous
- External IDs
- LN 144
- LN-144
- LN144
Pharmacology
- Indication
Lifileucel is indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation-positive, a BRAF inhibitor with or without a MEK inhibitor. This indication is approved under accelerated approval based on an objective response rate (ORR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).3
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Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Treatment of Metastatic melanoma •••••••••••• ••••• •••••••••• ••••••• •••• • •••• •••••••• ••••••••• •••••••••• ••••••• •••• • •••• ••••••••• Treatment of Metastatic melanoma •••••••••••• ••••• •••••••••• ••••••• •••• • •••• •••••••• •••••••• Treatment of Unresectable melanoma •••••••••••• ••••• •••••••••• ••••••• •••• • •••• •••••••• ••••••••• •••••••••• ••••••• •••• • •••• ••••••••• Treatment of Unresectable melanoma •••••••••••• ••••• •••••••••• ••••••• •••• • •••• •••••••• •••••••• - Contraindications & Blackbox Warnings
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Lifileucel mediates an antitumour immune response. In a clinical trial involving unresectable or metastatic melanoma, the objective response rate was 31.5% and the median time to initial response to lifileucel was 1.5 months.4
- Mechanism of action
The exact mechanism of action of lifileucel has not been fully elucidated. Lifileucel is composed of autologous tumour-infiltrating lymphocytes (TILS) that once administered, recognize tumour antigens and promote tumour cell lysis.1,2
- Absorption
Not Available
- Volume of distribution
Not Available
- Protein binding
Not Available
- Metabolism
- Not Available
- Route of elimination
Not Available
- Half-life
Not Available
- Clearance
Not Available
- Adverse Effects
Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates. View sample adverse effects data in our new Data Library!Improve decision support & research outcomes with our structured adverse effects data.- Toxicity
Not Available
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.Not Available
- Food Interactions
- No interactions found.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Amtagvi Suspension 72000000000 1/500mL Intravenous Iovance Biotherapeutics Inc. 2024-02-16 Not applicable US 
Categories
- Drug Categories
- Classification
- Not classified
- Affected organisms
- Humans and other mammals
Chemical Identifiers
- UNII
- R0835E18NH
- CAS number
- 2306267-74-1
References
- General References
- Sarnaik AA, Hamid O, Khushalani NI, Lewis KD, Medina T, Kluger HM, Thomas SS, Domingo-Musibay E, Pavlick AC, Whitman ED, Martin-Algarra S, Corrie P, Curti BD, Olah J, Lutzky J, Weber JS, Larkin JMG, Shi W, Takamura T, Jagasia M, Qin H, Wu X, Chartier C, Graf Finckenstein F, Fardis M, Kirkwood JM, Chesney JA: Lifileucel, a Tumor-Infiltrating Lymphocyte Therapy, in Metastatic Melanoma. J Clin Oncol. 2021 Aug 20;39(24):2656-2666. doi: 10.1200/JCO.21.00612. Epub 2021 May 12. [Article]
- Chesney J, Lewis KD, Kluger H, Hamid O, Whitman E, Thomas S, Wermke M, Cusnir M, Domingo-Musibay E, Phan GQ, Kirkwood JM, Hassel JC, Orloff M, Larkin J, Weber J, Furness AJS, Khushalani NI, Medina T, Egger ME, Graf Finckenstein F, Jagasia M, Hari P, Sulur G, Shi W, Wu X, Sarnaik A: Efficacy and safety of lifileucel, a one-time autologous tumor-infiltrating lymphocyte (TIL) cell therapy, in patients with advanced melanoma after progression on immune checkpoint inhibitors and targeted therapies: pooled analysis of consecutive cohorts of the C-144-01 study. J Immunother Cancer. 2022 Dec;10(12):e005755. doi: 10.1136/jitc-2022-005755. [Article]
- FDA Approved Drug Products: AMTAGVI (lifileucel) suspension for intravenous infusion [Link]
- FDA: FDA grants accelerated approval to lifileucel for unresectable or metastatic melanoma [Link]
- External Links
- 2675860
- Wikipedia
- Lifileucel
Clinical Trials
- Clinical Trials
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Suspension Intravenous 72000000000 1/500mL - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Liquid
- Experimental Properties
- Not Available
Drug created at November 14, 2022 22:15 / Updated at March 29, 2024 06:25