Lifileucel
Lifileucel, sold under the brand name Amtagvi, is an adoptive T cell therapy used for the treatment of melanoma.
Specifically, lifileucel is a tumor-derived T cell immunotherapy composed of a recipient's own T cells. A portion of the recipient's tumor tissue is removed during a surgical procedure prior to treatment. The recipient's T cells are separated from the tumor tissue, multiplied and then infused into the recipient in a single dose. T cells are a type of cell that helps the immune system fight cancer and infections.
The most common adverse reactions include chills, fever, fatigue, tachycardia, diarrhea, febrile neutropenia, edema, rash, hypotension, hair loss, infection, hypoxia and feeling short of breath. Lifileucel is the first tumor-derived T cell immunotherapy approved by the US Food and Drug Administration. It was approved for medical use in the United States in February 2024.
Medical uses
Lifileucel is indicated for the treatment of adults with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if [BRAF V600|BRAF V600] mutation positive, a BRAF inhibitor with or without a MEK inhibitor.Side effects
The most common adverse reactions include chills, fever, fatigue, tachycardia, diarrhea, febrile neutropenia, edema, rash, hypotension, hair loss, infection, hypoxia and feeling short of breath.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. A boxed warning is included in the prescribing informationl containing information about these risks.
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. Effectiveness was measured via the objective response rate to treatment and duration of response.The US Food and Drug Administration 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.
Society and culture
Legal status
Lifileucel was approved for medical use in the United States in February 2024.Names
Lifileucel is the international nonproprietary name.Lifileucel is sold under the brand name Amtagvi.