Amtagvi FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 21, 2024.
FDA Approved: Yes (First approved February 16, 2024)
Brand name: Amtagvi
Generic name: lifileucel
Dosage form: Suspension for Intravenous Infusion
Company: Iovance Biotherapeutics, Inc.
Treatment for: Melanoma
Amtagvi (lifileucel) is a tumor-derived autologous T cell immunotherapy used for the treatment of adult patients with unresectable or metastatic melanoma.
- Melanoma is a form of skin cancer that begins in the melanocytes of the skin. Unresectable means the cancer cannot be removed completely with surgery, and metastatic means the cancer cells have spread elsewhere from the primary tumor.
- Amtagvi 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 objective response rate (ORR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s) ( previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. - Amtagvi is an individualized therapy manufactured from naturally occurring tumor infiltrating lymphocyte (TIL) cells collected from the patient's tumor tissue. The TIL cells are infused back into the patient where they recognize tumor markers on the surface of the cancer cells, and then attack and destroy the cancer cells.
- Amtagvi is administered as a single dose intravenous infusion. Before receiving Amtagvi, patients will receive a lymphodepleting chemotherapy regimen (cyclophosphamide with mesna daily for 2 days followed fludarabine daily for 5 days). Approximately 30-60 minutes before receiving Amtagvi, acetaminophen and diphenhydramine (or another H1-antihistamine) will be administered as pre-medication.
- Amtagvi carries a boxed warning for treatment-related mortality, prolonged severe cytopenia, severe infections, and cardiopulmonary and renal impairment. Warnings and precautions include hypersensitivity reactions.
- Common adverse reactions include chills, pyrexia, fatigue, tachycardia, diarrhea, febrile neutropenia, edema, rash, hypotension, alopecia, infection, hypoxia, and dyspnea.
Development timeline for Amtagvi
Further information
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