AMTAGVI (lifileucel) · Iovance Biotherapeutics, Inc.
AMTAGVI is a tumor-derived autologous T cell immunotherapy 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 objective response rate (ORR) [see Clinical Studies ] .
Details
- Status
- Prescription
- First Approved
- 2024-02-15
- Patent Cliff
- 2036
- Routes
- Intravenous
- Dosage Forms
- Suspension
AMTAGVI Approval History
What AMTAGVI Treats
1 FDA approvalsOriginally approved for its first indication in 2024 .
- Other (1)
Other
(1 approval)- • Approved indication (Feb 2024)
AMTAGVI Boxed Warning
TREATMENT-RELATED MORTALITY, PROLONGED SEVERE CYTOPENIA, SEVERE INFECTION, CARDIOPULMONARY and RENAL IMPAIRMENT Monitor patients for prolonged severe cytopenia and monitor for internal organ hemorrhage [see Warnings and Precautions (5.1 , 5.2 , 5.3) ]. Administer filgrastim or a biosimilar product to patients beginning Day 1 after AMTAGVI and continuing daily until the absolute neutrophil count (ANC) is greater than 1000 per mm 3 for 3 consecutive days, or per institutional standard. Treat sever...
WARNING: TREATMENT-RELATED MORTALITY, PROLONGED SEVERE CYTOPENIA, SEVERE INFECTION, CARDIOPULMONARY and RENAL IMPAIRMENT Monitor patients for prolonged severe cytopenia and monitor for internal organ hemorrhage [see Warnings and Precautions (5.1 , 5.2 , 5.3) ]. Administer filgrastim or a biosimilar product to patients beginning Day 1 after AMTAGVI and continuing daily until the absolute neutrophil count (ANC) is greater than 1000 per mm 3 for 3 consecutive days, or per institutional standard. Treat severe infections [see Warnings and Precautions (5.1 , 5.4) ]. Monitor cardiopulmonary and renal functions throughout the treatment course. [see Warnings and Precautions (5.1 , 5.5 , 5.6 , 5.7) ]. Administer in an inpatient hospital setting. An intensive care facility and specialists skilled in cardiopulmonary or intensive care medicine must be available [see Dosage and Administration (2.1) , and Adverse Reactions (6.1) ] . WARNING: TREATMENT-RELATED MORTALITY, PROLONGED SEVERE CYTOPENIA, SEVERE INFECTION, CARDIOPULMONARY and RENAL IMPAIRMENT See full prescribing information for complete boxed warning. Monitor patients for prolonged severe cytopenia and monitor for internal organ hemorrhage ( 5.1 , 5.2 , 5.3 ) Treat severe infections ( 5.1 , 5.4 ) Monitor cardiopulmonary and renal functions throughout the treatment course ( 5.1 , 5.5 , 5.6 , 5.7 ) Administer in an inpatient hospital setting. An intensive care facility and specialists skilled in cardiopulmonary or intensive care medicine must be available ( 2.1 , 6.1 )
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06151847 | STUDY00150697 NCI-2023-09309, IIT-2022-LDTIL | Ph 2 | completed | Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable or Metastatic Melanoma |
| NCT06743126 SUPRAME | IMA203-301 | Ph 3 | recruiting | SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma |
| NCT07288203 | IOV-MEL-202 2025-522054-40-00 | Ph 2 | active not recruiting | A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Melanoma |
| NCT02360579 LN-144 results posted | C-144-01 | Ph 2 | completed | Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma |
| NCT05176470 | OSU-21202 NCI-2021-11063 | Ph 1 | active not recruiting | Neoadj Admin Autologous Tumor Infiltrating Lymphocytes & Pembrolizumab for Treatment of Adv Melanoma Patients |
| NCT06481592 | IOV-END-201 | Ph 2 | recruiting | A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Endometrial Cancer. |
| NCT03645928 | IOV-COM-202 2018-001608-12, 2024-510779-39-00 | Ph 2 | terminated | Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AMTAGVI FDA Label Details
Indications & Usage
AMTAGVI is a tumor-derived autologous T cell immunotherapy 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 objective response rate (ORR) [see Clinical Studies ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). AMTAGVI is a tumor-derived autologous T cell immunotherapy ...
WARNING: TREATMENT-RELATED MORTALITY, PROLONGED SEVERE CYTOPENIA, SEVERE INFECTION, CARDIOPULMONARY and RENAL IMPAIRMENT Monitor patients for prolonged severe cytopenia and monitor for internal organ hemorrhage [see Warnings and Precautions (5.1 , 5.2 , 5.3) ]. Administer filgrastim or a biosimilar ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.