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Lifileucel · Amtagvi, TIL

Cell therapy (Tumor-infiltrating lymphocytes) · Kills target cells, directed at tumor cells · developed by Iovance Biotherapeutics

Approved FDA, Feb 2024
IOVA Developer
13 Registered trials

What is Lifileucel?

Lifileucel (AMTAGVI) is an autologous tumor-infiltrating lymphocyte (TIL) cell therapy. Tumor-derived T cells are isolated from a patient's tumor sample, expanded ex vivo with interleukin-2, and reinfused to recognize and kill the patient's tumor cells.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as
Amtagvi, TIL, LN-145, LN-144, Tumor-Infiltrating Lymphocytes, OOS AMTAGVI
Drug type
Cell therapy (Tumor-infiltrating lymphocytes)
Targets
tumor cells (antigen)
Mechanism
Kills target cells, directed at tumor cells
Therapy area
Oncology
Developer
Iovance Biotherapeutics Inc. (IOVA)
FDA status
Approved as Amtagvi (February 16, 2024), BLA125773 · FDA label
UNII
R0835E18NH

✅ FDA-approved uses

From the indications section of the FDA label (version of Oct 14, 2025). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT05727904 Phase 3 Metastatic Melanoma Recruiting IOVA
NCT07288073 Phase 2 Cutaneous Squamous Cell Carcinoma Recruiting IOVA
NCT06481592 Phase 2 Endometrial Cancer Recruiting IOVA
NCT04111510 Phase 2 Metastatic Triple Negative Breast Cancer Completed IOVA
NCT03645928 Phase 2 Metastatic Melanoma Terminated IOVA
NCT03449108 Phase 2 Bone Sarcoma Active not recruiting IOVA
NCT03108495 Phase 2 Cervical Carcinoma Terminated IOVA
NCT06190249 Phase 1 Stage IIIB Melanoma Withdrawn IOVA
NCT06566092 Phase 1 Soft Tissue Sarcoma Active not recruiting IOVA
NCT05640193 Phase 1 Metastatic Melanoma Active not recruiting IOVA
NCT05607095 Phase 1 Uveal Melanoma Recruiting IOVA
NCT07700121 Early Phase 1 Unresectable or Metastatic Melanoma Not yet recruiting IOVA
NCT05398640 N/A Unresectable Melanoma Available IOVA

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Bone SarcomaDedifferentiated ChondrosarcomaGiant Cell Tumor of BoneMalignancy in Giant Cell Tumor of BoneMalignant Solid NeoplasmOvarian CarcinosarcomaPlatinum-Resistant Ovarian CarcinomaPoorly Differentiated Thyroid Gland CarcinomaRecurrent OsteosarcomaRecurrent Ovarian CarcinomaRefractory OsteosarcomaSoft Tissue SarcomaThyroid Gland Anaplastic CarcinomaThyroid Gland Squamous Cell Carcinoma

More from Iovance Biotherapeutics

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the IOVA page.

Follow IOVA, the company behind Lifileucel

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.