Lifileucel
Generic Name: lifileucel
Brand Names:
Amtagvi
11 DESCRIPTION AMTAGVI (lifileucel) is a tumor-derived autologous T cell immunotherapy comprised of a suspension of tumor-derived T cells for intravenous infusion. AMTAGVI is manufactured from resected patient tumor tissue prosected from one or more tumor lesions. Immune cells derived from a patient's tumor(s) are expanded in cell culture, washed, formulated as a cell suspension, and cryopreserved.
Overview
11 DESCRIPTION AMTAGVI (lifileucel) is a tumor-derived autologous T cell immunotherapy comprised of a suspension of tumor-derived T cells for intravenous infusion. AMTAGVI is manufactured from resected patient tumor tissue prosected from one or more tumor lesions. Immune cells derived from a patient's tumor(s) are expanded in cell culture, washed, formulated as a cell suspension, and cryopreserved.
Uses
1 INDICATIONS AND USAGE 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) [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Dosage
2 DOSAGE AND ADMINISTRATION For autologous use only. For intravenous use only. Verify the patient's identity prior to infusion. 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 ( 2.1 ) The AMTAGVI dose is between 7.5 × 10 9 and 72 × 10 9 viable cells ( 2.1 ) Administer a lymphodepleting regimen before infusion of AMTAGVI ( 2.2 ) Do NOT use a leukocyte depleting filter with AMTAGVI ( 2.2 ) Premedicate the patient with acetaminophen, or equivalent, and diphenhydramine, or another H1-antihistamine ( 2.2 ) Avoid prophylactic use of systemic corticosteroids ( 2.2 ) Administer entire dose of AMTAGVI ( 2.2 ) Administer IL-2 (aldesleukin) after infusion of AMTAGVI...
Side Effects
6 ADVERSE 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. The serious adverse reactions included: Treatment-Related Mortality [see Warnings and Precautions (5.1) ] Prolonged Severe Cytopenia [see Warnings and Precautions (5.2) ] Internal Organ Hemorrhage [see Warnings and Precautions (5.3) ] Severe Infection [see Warnings and Precautions (5.4) ] Cardiac Disorder [see Warnings and Precautions (5.5) ] Respiratory Failure [see Warnings and Precautions (5.6) ] Acute Renal Failure [see Warnings and Precautions (5.7) ] Hypersensitivity Reactions [see Warnings and Prec...
Warnings
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 [see Warnings and Precautions (5.1 , 5.2 , 5.3) ]. Administer filgrastim or a biosimilar product to patients beginning Day 1 after AMTAGVI and continuing daily until the absolute neutrophil count (ANC) is greater than 1000 per mm 3 for 3 consecutive days, or per institutional standard. 5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions: Monitor for hypersensitivity reactions during infusion ( 5.8 ) 5.1 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. Adverse reactions associated with these deaths included severe infections (sepsis, pneumonia and encephalitis), internal organ hemorrhage (abdominal hemorrhage and intracranial hemorrhage), acute renal failure, acute respiratory failure, cardiac arrythmia, extensive ascites, liver injury, and bone marrow failure. 4 CONTRAINDICATIONS None. None ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary There are no available data with AMTAGVI use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with AMTAGVI. Therefore, AMTAGVI is not recommended for women who are pregnant, and pregnancy after AMTAGVI administration should be discussed with the treating physician. Report pregnancies to Iovance Biotherapeutics, Inc. at 1-833-400-IOVA. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Storage
Product and patient-specific labels are located on both the product infusion bag(s) and the protective shipping cassette(s), which are inside the liquid nitrogen cryoshipper. Match the identity of the patient with the patient identifiers on the cassette(s) and infusion bag(s) upon receipt.
Frequently Asked Questions
What is Lifileucel used for?▼
1 INDICATIONS AND USAGE 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) [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
What are the side effects of Lifileucel?▼
6 ADVERSE 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. The serious adverse reactions included: Treatment-Related Mortality [see Warnings and Precautions (5.1) ] Prolonged Severe Cytopenia [see Warnings and Precautions (5.2) ] Internal Organ Hemorrhage [see Warnings and Precautions (5.3) ] Severe Infection [see Warnings and Precautions (5.4) ] Cardiac Disorder [see Warnings and Precautions (5.5) ] Respiratory Failure [see Warnings and Precautions (5.6) ] Acute Renal Failure [see Warnings and Precautions (5.7) ] Hypersensitivity Reactions [see Warnings and Prec...
Can I take Lifileucel during pregnancy?▼
8.1 Pregnancy Risk Summary There are no available data with AMTAGVI use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with AMTAGVI. Therefore, AMTAGVI is not recommended for women who are pregnant, and pregnancy after AMTAGVI administration should be discussed with the treating physician. Report pregnancies to Iovance Biotherapeutics, Inc. at 1-833-400-IOVA. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
What are the important warnings for Lifileucel?▼
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 [see Warnings and Precautions (5.1 , 5.2 , 5.3) ]. Administer filgrastim or a biosimilar product to patients beginning Day 1 after AMTAGVI and continuing daily until the absolute neutrophil count (ANC) is greater than 1000 per mm 3 for 3 consecutive days, or per institutional standard. 5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions: Monitor for hypersensitivity reactions during infusion ( 5.8 ) 5.1 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. Adverse reactions associated with these deaths included severe infections (sepsis, pneumonia and encephalitis), internal organ hemorrhage (abdominal hemorrhage and intracranial hemorrhage), acute renal failure, acute respiratory failure, cardiac arrythmia, extensive ascites, liver injury, and bone marrow failure. 4 CONTRAINDICATIONS None. None ( 4 )
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This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.