Lifileucel
Lifileucel is an autologous tumor-infiltrating lymphocyte (TIL) therapy designed to treat advanced melanoma. The treatment involves harvesting a patient's own immune cells that have infiltrated their tumor, expanding them to large numbers in a laboratory, and then reinfusing them back into the patient to enhance the immune system's ability to attack cancer cells.
Lifileucel is a personalized cell therapy using a patient's own immune cells to treat advanced melanoma that has not responded to other treatments.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- L01XL11
- RxNorm
- 2675860
- Generic
- Lifileucel
- Class
- atc-l01
- Brands
- Amtagvi
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
10 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks - lifileucel is an autologous cellular therapy and its effects on fetal development are unknown
regular fetal monitoring if treatment required
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
third trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingavoid
discontinue breastfeeding during treatment and for at least 6 months after last dose
none specific
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
elderly 65 and olderno specific adjustment
use with caution - clinical trials included limited elderly patients; monitor for adverse effects
close monitoring for infusion reactions and adverse events
Use with caution and monitor for adverse effects.
pediatric_age
pediatrics under 18not applicable
not approved for use in pediatric patients - safety and efficacy not established in patients under 18 years
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
renal_impairment
mild renal impairmentno adjustment required
no dose adjustment recommended for mild renal impairment
standard monitoring
renal_impairment
moderate severe renal impairmentuse with caution
use with caution - limited data available; individual assessment required
enhanced monitoring for adverse effects
Use with caution and monitor for adverse effects.
hepatic_impairment
mild hepatic impairmentno adjustment required
no dose adjustment recommended for mild hepatic impairment
standard monitoring
hepatic_impairment
moderate severe hepatic impairmentuse with caution
use with caution - limited data available; individual assessment required
enhanced monitoring for adverse effects
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval date
First FDA-approved tumor infiltrating lymphocyte (TIL) therapy
Drug class
Autologous cellular immunotherapy
Indication
Approved indication for adult patients
Administration
Treatment regimen
Lifileucel (AMTAGVI) is indicated for the treatment of adult patients with unresectable or metastatic melanoma who have previously been treated with a PD-1 inhibitor and, if BRAF V600 mutation positive, a BRAF inhibitor or MEK inhibitor.
Lifileucel is a personalized immunotherapy that uses the patient's own tumor-infiltrating lymphocytes (TILs). These immune cells are extracted from the patient's tumor tissue, grown to billions of cells in a lab, and then returned to the patient via infusion. The expanded T cells are better able to recognize and attack the patient's cancer cells.
Lifileucel is administered as a single infusion following non-myeloablative lymphodepleting chemotherapy. Due to its personalized nature, treatment requires specialized manufacturing and cannot be stored. Common adverse reactions include cytokine release syndrome, fever, chills, fatigue, and infections. Patients should be monitored closely during and after infusion for potential serious reactions.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy