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Innovation Observatory > Reports > Drugs > Lifileucel for unresectable or metastatic melanoma – second-line or greater

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Lifileucel for unresectable or metastatic melanoma – second-line or greater


Cancer and Palliative Care

August 2020

Lifileucel is being developed for the treatment of patients with unresectable or metastatic melanoma who have previously been treated with at least one systemic therapy. Melanoma is characterised by the uncontrolled growth of melanocytes, which are cells that protect against ultraviolet radiation through the production of the dark pigment melanin. Advanced or metastatic (stage IV) melanoma is cancer that has spread to distant areas or other organs such as the lungs, liver or brain. The general symptoms of advanced melanoma can include weight loss, loss of appetite and fatigue.
Lifileucel uses a novel mechanism of action to treat stage IV melanoma for which there are currently no autologous tumour-infiltrating lymphocytes (TIL)-based therapies recommended. It is composed of a patient’s own naturally occurring immune cells TIL, which are prepared from a sample of cancerous tumour removed from the patient and multiplied in a laboratory until billions of TIL are obtained. The expanded TIL are then administered via intravenous infusion back to the patient with the intention that TIL will target and infiltrate cancer in the patient and attack the cancer in greater number. If licensed, lifileucel will offer an additional treatment option for patients with previously treated unresectable or metastatic melanoma and for patients who have progressed on multiple therapies, who are currently without additional effective options.

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