Lifileucel, sold under the brand name Amtagvi, is an adoptive T cell therapy used for the treatment of melanoma.^[1][2][3]

Specifically, Lifileucel is a tumor-derived T cell immunotherapy composed of a recipient's own T cells. A portion of the patient's tumor tissue is removed during a surgical procedure prior to treatment.^[3] The recipient's T cells (the tumor-infiltrating lymphocytes) are separated from the tumor tissue, multiplied and then infused into the patient in a single dose.^[3] T cells are a type of cell that helps the immune system fight cancer and infections.^[3]

It is the first tumor-derived T cell immunotherapy approved by the US Food and Drug Administration (FDA).^[3] Lifileucel was approved for medical use in the United States in February 2024.^[2][4][5]

Medical uses

Lifileucel is indicated for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (spread to other parts of the body) melanoma previously treated with other therapies (a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor).^[3]

History

The safety and effectiveness of lifileucel was evaluated in a global, multicenter, multicohort, 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.^[3] Effectiveness was measured via the objective response rate to treatment and duration of response (measured from the date of confirmed initial objective response to the date of progression, death from any cause, starting a new anti-cancer treatment or discontinuation from follow-up, whichever came first).^[3]

The FDA 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 trade name Amtagvi to Iovance Biotherapeutics.^[3]

Side effects

The most common adverse reactions include chills, fever, fatigue, tachycardia (abnormally fast heart rate), diarrhea, febrile neutropenia (fever associated with a low level of certain white blood cells), edema (swelling due to buildup of fluid in body tissues), rash, hypotension, hair loss, infection, hypoxia (abnormally low oxygen levels in the body) and feeling short of breath.^[3]

Society and culture

Names

Lifileucel is the international nonproprietary name.^[6]