The safety profile of AMTAGVI™ reflects the observed safety profile of the regimen, including lymphodepletion and IL-2 (aldesleukin)1

Adverse reactions in the C-144-01 study

Adverse Reactions Observed in at Least 10% of Patients Treated With AMTAGVI (N=156)1

Adverse ReactionAll Grades
n (%)		Grades ≥3
n (%)
Blood and lymphatic system disorders
Febrile neutropenia73 (46.8)73 (46.8)
Cardiac disorders
Tachycardiaa74 (47.4)12 (7.7)
Gastrointestinal disorders
Diarrhea73 (46.8)3 (1.9)
Vomiting68 (43.6)2 (1.3)
Nausea107 (68.6)4 (2.6)
General disorders and administration site conditions
Chills118 (75.6)8 (5.1)
Pyrexia95 (60.9)16 (10.3)
Fatigueb87 (55.8)8 (5.1)
Edemac66 (42.3)8 (5.1)
Investigations
Weight increased30 (19.2)2 (1.3)
Infections and Infestations42 (26.9)21 (13.5)
Infection with pathogen unspecifiedd130 (19.2)17 (10.9)
Infection with pathogen specifiedd219 (12.2)6 (3.8)
Adverse ReactionAll Grades
n (%)		Grades ≥3
n (%)
Metabolism and nutrition disorders
Decreased appetite48 (30.8)2 (1.3)
Nervous system disorders
Headache33 (21.2)1 (0.6)
Encephalopathye27 (17.3)9 (5.8)
Renal and urinary disorders
Acute kidney injuryf31 (19.9)11 (7.1)
Hematuria22 (14.1)2 (1.3)
Respiratory, thoracic and mediastinal disorders
Hypoxiag37 (23.7)19 (12.2)
Dyspneah34 (21.8)13 (8.3)
Skin and subcutaneous tissue disorders
Rashi58 (37.2)15 (9.6)
Alopecia48 (30.8)0 (0)
Pruritus21 (13.5)0 (0)
Vascular disorders
Hypotensionj58 (37.2)17 (10.9)
Capillary leak syndrome21 (13.5)7 (4.5)
Hypertensionk21 (13.5)11 (7.1)

Adverse reactions occurred from AMTAGVI infusion to 6 months (182 days) post infusion.

aTachycardia includes tachycardia and sinus tachycardia, atrial fibrillation, supraventricular tachycardia.1

bFatigue includes fatigue, asthenia, and malaise.1

cEdema includes edema, face edema, generalized edema, localized edema, edema peripheral, peripheral swelling, edema genital, scrotal edema, brain edema, catheter site edema, conjunctival edema, eyelid edema, laryngeal edema, macular edema, periorbital edema, pulmonary edema, vasogenic cerebral edema, and lymphoedema.1

d1Infection with unspecified pathogen includes cellulitis, conjunctivitis, cystitis, dermatitis infected, device related infection, diarrhea infectious, endocarditis, enterocolitis infectious, infection, meningitis, nasopharyngitis, neutropenic sepsis, pneumonia, pyuria, rash pustular, respiratory tract infection (RTI), rhinitis, sepsis, sinusitis, skin infection, urinary tract infection (UTI).1

d2Infection with mentioned pathogen includes bacteremia, candida infection, clostridium difficile colitis, cytomegalovirus infection or reactivation, Epstein-Barr virus infection, escherichia bacteraemia, fungal skin infection, herpes simplex, herpes zoster, metapneumovirus infection, oral herpes, oral candidiasis, pneumonia klebsiella, respiratory syncytial virus infection, skin candida, tuberculosis.1

eEncephalopathy includes encephalopathy, automatism, cognitive disorder, confusional state, depressed level of consciousness, disturbance in attention, hypersomnia, lethargy, leukoencephalopathy, memory impairment, mental status changes, paranoia, somnolence, and stupor.1

fAcute kidney injury includes acute kidney injury, anuria, azotemia, renal failure, renal tubular dysfunction, renal tubular necrosis, oliguria, and blood creatinine increased.1

gHypoxia includes hypoxia and oxygen saturation decreased.1

hDyspnea includes dyspnea, acute respiratory failure, orthopnea, respiratory distress, respiratory failure, and dyspnea exertional.1

iRash includes rash, rash generalized, rash maculo-papular, rash papular, rash pruritic, rash erythematous, and rash macular.1

jHypotension includes hypotension, blood pressure decreased, blood pressure systolic decreased, blood pressure diastolic decreased, and orthostatic hypotension.1

kHypertension includes hypertension, blood pressure increased, blood pressure systolic increased, and blood pressure diastolic increased.1

The majority of adverse events emerged within the first 15 days after treatment with AMTAGVI2

Treatment-emergent Adverse Events Over Time

A graph showing the rates and severity of adverse reactions after treatment with AMTAGVI.A graph showing the rates and severity of adverse reactions after treatment with AMTAGVI.
  • Among 160 advanced melanoma patients who initiated the AMTAGVI regimen, there were 12 deaths (7.5%)1
  • Grade 3 or higher cytopenia or pancytopenia which did not resolve to less than or equal to Grade 2 or lasted beyond 30 days post AMTAGVI infusion occurred in 45.5% of melanoma patients who received AMTAGVI. Filgrastim or a biosimilar product should be administered to patients beginning Day 1 after AMTAGVI and continuing daily until the absolute neutrophil count (ANC) is greater than 1000 per mm3 for 3 consecutive days, or per institutional standard.1

IL-2, interleukin-2; TEAE, treatment-emergent adverse event.

GO TO REFERRING A PATIENT FOR AMTAGVI

Initiate multidisciplinary collaboration early when considering patients for AMTAGVI treatment

Referring a patient for AMTAGVI

Downloadable materials available for patients and healthcare professionals

Discover resources

What is AMTAGVI (lifileucel)?

AMTAGVI is a prescription medicine used to treat adults with a type of skin cancer that cannot be removed surgically or has spread to other parts of the body called unresectable or metastatic melanoma.

AMTAGVI is used when your melanoma has not responded or stopped responding to a PD-1 blocking drug either by itself or in a combination, and if your cancer is BRAF mutation positive, a BRAF inhibitor drug with or without a MEK inhibitor drug that has also stopped working.

The approval of AMTAGVI is based on a study that measured response rate. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

Please see accompanying Full Prescribing Information and Patient Information, including BOXED WARNINGS, for additional Important Safety Information.

Important Safety Information

AMTAGVI is associated with serious and potentially life-threatening or fatal side effects, including treatment-related death, prolonged severe low blood cell counts (cytopenia), serious infections, and cardiopulmonary (heart, lung) and renal (kidney) impairment. Your healthcare provider will monitor you for these side effects during treatment.

What is the most important information that I should know about AMTAGVI?

You will likely be in a hospital prior to and after receiving AMTAGVI.

Before taking AMTAGVI, tell your healthcare provider about all of your medical conditions, including if you:

  • Have any lung, heart, liver or kidney problems
  • Have low blood pressure
  • Have a recent or active infection or other inflammatory conditions including cytomegalovirus (CMV) infection, hepatitis B or C or human immunodeficiency virus (HIV) infection
  • Are pregnant, think you may be pregnant, or plan to become pregnant
  • Are breastfeeding
  • Notice the symptoms of your cancer are getting worse
  • Have had a vaccination in the past 28 days or plan to have one in the next few months
  • Have been taking a blood thinner

Tell your doctor about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive AMTAGVI?

  • AMTAGVI is made from your surgically removed tumor. Tumor derived T cells are grown in a manufacturing center at the end of which they number in the billions of cells.
  • Your tumor tissue is sent to a manufacturing center to make AMTAGVI. It takes about 34 days from the time your tumor tissue is received at the manufacturing center until AMTAGVI is available to be shipped back to your healthcare provider, but the time may vary. Your AMTAGVI will be provided in 1-4 patient-specific infusion bag(s) containing 100 mL to 125 mL of viable (alive) cells per bag.
  • After your AMTAGVI arrives at your treating institution, your healthcare provider will give you lymphodepleting chemotherapy to prepare your body.
  • Approximately 30 to 60 minutes before you are given AMTAGVI, you may be given other medicines including:
    • Medicines for an allergic reaction (anti-histamines)
    • Medicines for fever (such as acetaminophen)
  • Your AMTAGVI will be provided in 1 to 4 infusion bag(s) containing 100 mL to 125 mL of viable cells per bag. When your body is ready for AMTAGVI infusion, your healthcare provider will give AMTAGVI to you by intravenous infusion. This usually takes less than 90 minutes.

After getting AMTAGVI

Beginning 3 to 24 hours after AMTAGVI is given, you may be given up to 6 doses of IL-2 (aldesleukin) every 8 to 12 hours via intravenous infusion. Your doctor may discontinue IL-2 (aldesleukin) infusion any time if you have severe side effects.

You will have to stay in the hospital until you have completed the IL-2 (aldesleukin) treatment and you have recovered from any serious side effects associated with the AMTAGVI treatment.

You should plan to stay within 2 hours of the location where you received your treatment for several weeks after getting AMTAGVI. Your healthcare provider will check to see if your treatment is working and help you with any side effects that occur.

What are the possible side effects of AMTAGVI?

The most common side effects of the AMTAGVI treatment include chills, fever, low white blood cell count (may increase risk of infections), fatigue, low red blood cell count (may cause you to feel tired or weak), fast or irregular heartbeat, rash, low blood pressure, and diarrhea.

These are not all the possible side effects of the AMTAGVI treatment. Talk with your healthcare provider for more information about AMTAGVI. You can ask your healthcare provider for information about AMTAGVI that is written for healthcare professionals.

You may report side effects to Iovance at 1-833-400-46821-833-400-4682, or to the FDA, at 1-800-FDA-10881-800-FDA-1088 or at www.fda.gov/medwatch.

Please see accompanying Full Prescribing Information and Patient Information, including Boxed WARNINGS, for additional Important Safety Information.

 

What is AMTAGVI (lifileucel)?

AMTAGVI is a prescription medicine used to treat adults with a type of skin cancer that cannot be removed surgically or has spread to other parts of the body called unresectable or metastatic melanoma.

AMTAGVI is used when your melanoma has not responded or stopped responding to a PD-1 blocking drug either by itself or in a combination, and if your cancer is BRAF mutation positive, a BRAF inhibitor drug with or without a MEK inhibitor drug that has also stopped working.

The approval of AMTAGVI is based on a study that measured response rate. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

Please see accompanying Full Prescribing Information and Patient Information, including BOXED WARNINGS, for additional Important Safety Information.

Important Safety Information

AMTAGVI is associated with serious and potentially life-threatening or fatal side effects, including treatment-related death, prolonged severe low blood cell counts (cytopenia), serious infections, and cardiopulmonary (heart, lung) and renal (kidney) impairment. Your healthcare provider will monitor you for these side effects during treatment.

What is the most important information that I should know about AMTAGVI?

You will likely be in a hospital prior to and after receiving AMTAGVI.

Before taking AMTAGVI, tell your healthcare provider about all of your medical conditions, including if you:

  • Have any lung, heart, liver or kidney problems
  • Have low blood pressure
  • Have a recent or active infection or other inflammatory conditions including cytomegalovirus (CMV) infection, hepatitis B or C or human immunodeficiency virus (HIV) infection
  • Are pregnant, think you may be pregnant, or plan to become pregnant
  • Are breastfeeding
  • Notice the symptoms of your cancer are getting worse
  • Have had a vaccination in the past 28 days or plan to have one in the next few months
  • Have been taking a blood thinner

Tell your doctor about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive AMTAGVI?

  • AMTAGVI is made from your surgically removed tumor. Tumor derived T cells are grown in a manufacturing center at the end of which they number in the billions of cells.
  • Your tumor tissue is sent to a manufacturing center to make AMTAGVI. It takes about 34 days from the time your tumor tissue is received at the manufacturing center until AMTAGVI is available to be shipped back to your healthcare provider, but the time may vary. Your AMTAGVI will be provided in 1-4 patient-specific infusion bag(s) containing 100 mL to 125 mL of viable (alive) cells per bag.
  • After your AMTAGVI arrives at your treating institution, your healthcare provider will give you lymphodepleting chemotherapy to prepare your body.
  • Approximately 30 to 60 minutes before you are given AMTAGVI, you may be given other medicines including:
    • Medicines for an allergic reaction (anti-histamines)
    • Medicines for fever (such as acetaminophen)
  • Your AMTAGVI will be provided in 1 to 4 infusion bag(s) containing 100 mL to 125 mL of viable cells per bag. When your body is ready for AMTAGVI infusion, your healthcare provider will give AMTAGVI to you by intravenous infusion. This usually takes less than 90 minutes.

After getting AMTAGVI

Beginning 3 to 24 hours after AMTAGVI is given, you may be given up to 6 doses of IL-2 (aldesleukin) every 8 to 12 hours via intravenous infusion. Your doctor may discontinue IL-2 (aldesleukin) infusion any time if you have severe side effects.

You will have to stay in the hospital until you have completed the IL-2 (aldesleukin) treatment and you have recovered from any serious side effects associated with the AMTAGVI treatment.

You should plan to stay within 2 hours of the location where you received your treatment for several weeks after getting AMTAGVI. Your healthcare provider will check to see if your treatment is working and help you with any side effects that occur.

What are the possible side effects of AMTAGVI?

The most common side effects of the AMTAGVI treatment include chills, fever, low white blood cell count (may increase risk of infections), fatigue, low red blood cell count (may cause you to feel tired or weak), fast or irregular heartbeat, rash, low blood pressure, and diarrhea.

These are not all the possible side effects of the AMTAGVI treatment. Talk with your healthcare provider for more information about AMTAGVI. You can ask your healthcare provider for information about AMTAGVI that is written for healthcare professionals.

You may report side effects to Iovance at 1-833-400-46821-833-400-4682, or to the FDA, at 1-800-FDA-10881-800-FDA-1088 or at www.fda.gov/medwatch.

Please see accompanying Full Prescribing Information and Patient Information, including Boxed WARNINGS, for additional Important Safety Information.