Lifileucel

AMTAGVI is a tumor-derived autologous T cell immunotherapy 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).

The specific mechanism of action of AMTAGVI (lifileucel) is unknown.

For autologous use only. For intravenous use only. Verify the patient's identity prior to infusion. Administer AMTAGVI in an inpatient hospital setting with an intensive care facility. The AMTAGVI dose is between 7.5 × 10 9 and 72 × 10 9 viable cells. Administer a lymphodepleting regimen before infusion of AMTAGVI. Do NOT use a leukocyte depleting filter with AMTAGVI. Premedicate the patient with acetaminophen, or equivalent, and diphenhydramine, or another H1-antihistamine. Avoid prophylactic use of systemic corticosteroids. Administer entire dose of AMTAGVI. Administer IL-2 (aldesleukin) after infusion of AMTAGVI. See Full Prescribing Information for instructions on receipt, preparation, and administration of AMTAGVI

None. None

Boxed warning (treatment-related mortality, prolonged severe cytopenia, severe infection, cardiopulmonary and renal impairment): Monitor patients for prolonged severe cytopenia and monitor for internal organ hemorrhage. Hypersensitivity reactions: Monitor for hypersensitivity reactions during infusion Treatment-Related Mortality AMTAGVI is associated with treatment-related mortality. In the clinical trial, the treatment-related mortality rate was 7.5% (N=160), including 2 deaths during the lymphodepleting period, 6 deaths within 30 days, and 4 deaths 38 to 150 days following AMTAGVI administration.

The most common (incidence of greater than or equal to 20%) non-laboratory adverse reactions in order of decreasing frequency were chills, pyrexia, fatigue, tachycardia, diarrhea, febrile neutropenia, edema, rash, hypotension, alopecia, infection, hypoxia, and dyspnea. The serious adverse reactions included: Treatment-Related Mortality Prolonged Severe Cytopenia Internal Organ Hemorrhage Severe Infection Cardiac Disorder Respiratory Failure Acute Renal Failure Hypersensitivity Reactions The most common (incidence of greater than or equal to 20%) non-laboratory adverse reactions in order of decreasing frequency were chills, pyrexia, fatigue, tachycardia, diarrhea, febrile neutropenia, edema, rash, hypotension, alopecia, infection, hypoxia, and dyspnea

Store AMTAGVI frozen in the vapor phase of liquid nitrogen (less than or equal to minus 150°C).