View by Tumor Type
Melanoma
Home › All Therapies › Amtagvi

Amtagvi

lifileucel
TIL Cell Therapy FDA Approved 2024 Iovance
Route
Intralesional
Half-Life
N/A
FDA Approved
2024
Manufacturer
Iovance
Navigation -->
1. Indications and Usage

Melanoma: Unresectable/metastatic melanoma after prior anti-PD-1 (and BRAF ± MEK inhibitor if V600+).

2. Dosage and Administration

Single IV infusion of 7.5×10⁹ to 72×10⁹ viable T cells after lymphodepletion (cyclophosphamide/fludarabine). Post-infusion IL-2.

3. Dosage Forms and Strengths

Cell suspension for IV infusion

4. Contraindications

None listed.

5. Warnings and Precautions
  • Treatment-Related Mortality: Deaths reported.
  • Prolonged Cytopenia: Weeks to months. Monitor CBCs.
  • Severe Infections: Fatal infections reported.
  • Cardiac Reactions: Cardiac arrest reported.
  • Embryo-Fetal Toxicity: Lymphodepleting chemo causes harm.
6. Adverse Reactions
Most Common Adverse Reactions

Cytopenia (100%), Infection (55%), Fatigue (48%), Pyrexia (43%), Tachycardia (34%), Diarrhea (33%), Hypotension (32%), Edema (30%)

Cytopenia
100%
Infection
55%
Fatigue
48%
Pyrexia
43%
Tachycardia
34%
Diarrhea
33%
Hypotension
32%
Edema
30%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

Systemic corticosteroids may interfere with TIL activity.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Autologous tumor-infiltrating lymphocytes harvested, expanded ex vivo, and reinfused to mount polyclonal T-cell response against tumor cells.

Pharmacokinetics

Cell therapy; traditional PK not applicable.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Amtagvi Trials on ClinicalTrials.gov ↗ 📚 PubMed: Amtagvi Clinical Trials ↗
FDA-Approved Tumor Types

Amtagvi has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Melanoma
External Resources
📋 DailyMed Label ↗ 🏛️ FDA Drugs@FDA ↗ 🔬 ClinicalTrials.gov ↗ 📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Amtagvi. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Amtagvi (lifileucel) approved for?

Amtagvi (lifileucel) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Amtagvi (lifileucel) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Amtagvi (lifileucel) work?

Autologous tumor-infiltrating lymphocytes harvested, expanded ex vivo, and reinfused to mount polyclonal T-cell response against tumor cells.

What are the most common side effects?

Cytopenia (100%), Infection (55%), Fatigue (48%), Pyrexia (43%), Tachycardia (34%), Diarrhea (33%), Hypotension (32%), Edema (30%) Cytopenia 100% Infection 55% Fatigue 48% Pyrexia 43% Tachycardia 34% Diarrhea 33% Hypotension 32% Edema 30%

← All Therapies Full Prescribing Information ↗