Active Ingredient: Lifileucel
Lifileucel 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).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, between 750,000,000 cells lifileucel and 72,000,000,000 cells lifileucel, one dose.
For autologous use only. For intravenous use only.
Verify the patient’s identity prior to infusion.
Administer in an inpatient hospital setting under the supervision of a physician experienced in the use of anticancer agents. An intensive care facility and specialists skilled in cardiopulmonary or intensive care medicine must be available. Lifileucel is provided as a single dose for infusion containing a suspension of tumor-derived T cells. The dose is supplied in 1 to 4 patient-specific IV infusion bag(s) in individual protective metal cassettes. Each dose contains 7.5 × 109 to 72 × 109 viable cells.
Lifileucel is for autologous use only.
The patient’s identity must match the patient identifiers on the lifileucel cassette(s) and infusion bag(s).
Confirm availability of lifileucel and IL-2 (aldesleukin) prior to starting the lymphodepleting regimen.
Administer a lymphodepleting chemotherapy regimen of cyclophosphamide 60 mg/kg intravenously with mesna daily for 2 days followed by fludarabine 25 mg/m² intravenously daily for 5 days before infusion of lifileucel.
Infuse lifileucel as soon as possible after 24 hours have elapsed following the last dose of fludarabine, but no later than 4 days.
Pre-medicate the patient with acetaminophen and diphenhydramine or another H1-antihistamine, approximately 30 to 60 minutes prior to lifileucel infusion.
Avoid prophylactic use of systemic corticosteroids which may interfere with the activity of lifileucel.
Beginning 3 to 24 hours after lifileucel infusion, administer intravenous IL-2 (aldesleukin) at 600,000 IU/kg every 8 to 12 hours for up to a maximum of 6 doses to support cell expansion in vivo. IL-2 (aldesleukin) should be administered in an inpatient setting under the supervision of a physician experienced in the use of anticancer agents.
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