Your cells. Your treatment.

Preparing to receive AMTAGVI™ is an important step in your melanoma treatment journey. Keep in mind that AMTAGVI is only available at Authorized Treatment Centers around the United States.

Your healthcare team will refer you to an Authorized Treatment Center to be evaluated for treatment if you are not already being treated at one. You can also find a treatment center close to you using the Authorized Treatment Center locator tool.

When it is time for your treatment, it is important for you and your care partner to be informed about the time it takes for AMTAGVI to be made and what you can expect during each phase of your treatment process.

The AMTAGVI tumor-to-treatment administration

AMTAGVI is a one-time, individualized therapy that takes about 1 month to make. When it is time to receive your AMTAGVI therapy, you will go to your Authorized Treatment Center, where you will be cared for and monitored by your healthcare team.*

*Learn more about each step of AMTAGVI.

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Tumor tissue

A small piece of your tumor tissue will be removed, possibly during an outpatient procedure. This tissue is used to collect your T cells that will make your individualized AMTAGVI therapy.

  • The location of your tumor tissue in your body determines which specialized surgeon will perform this procedure
  • If you have multiple tumors, your treatment center team—in partnership with specialized surgeons—will determine the best location to collect your tumor tissue from
  • If your procedure is outpatient, some patients may return home the same day of the procedure
  • After your tumor tissue is removed, it is then shipped to a specialized manufacturing facility to create your AMTAGVI therapy

Creating AMTAGVI

  • At the specialized manufacturing facility, your T cells become separated from other cells within the tumor tissue
  • Your T cells are then grown into the billions†
  • These cells, known as AMTAGVI, are shipped back to the treatment center to be administered as part of the AMTAGVI treatment process

†Each dose of AMTAGVI contains 7.5 x 109 to 72 x 109 viable cells.

3-step treatment process

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Days 1-7

Step 1: Short course of Lymphodepleting chemotherapy:
Chemotherapy that is used to decrease the number of T cells in your body to prepare your body for AMTAGVI.

  • Starting 7 days before receiving AMTAGVI, you will receive a short course of chemotherapy
  • This chemotherapy is made up of 2 medications plus supportive medicines
  • It helps prepare your body to receive your AMTAGVI
Day 8

Step 2: AMTAGVI

You will receive AMTAGVI in the hospital as a one-time treatment.

  • Your AMTAGVI treatment will be given no sooner than 24 hours after your last dose of the lymphodepleting chemotherapy
  • Your AMTAGVI dose is contained in 1 to 4 patient-specific infusion bag(s)
  • Just before and after receiving AMTAGVI, you will receive other medicines to support your treatment
  • 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
Days 9-11

Step 3: Short course of Interleukin-2 (IL-2) (aldesleukin):
A drug given as an infusion into your vein that helps to support AMTAGVI activity in the body.

  • This treatment is given to support AMTAGVI T cell activity within your body
  • This part of the AMTAGVI treatment process is administered inpatient while at the hospital and typically takes up to 3 days
  • Your healthcare team will continue to monitor you for any side effects you may experience during this time

Following completion of your AMTAGVI treatment, your healthcare team will monitor you for any side effects and discharge you from your Authorized Treatment Center when they believe you are ready to return home.

Find helpful support on your treatment journey

SUPPORT AND RESOURCES

AMTAGVI is available at
Authorized Treatment Centers

Find a center near you

Useful tools and resources for your treatment journey

DOwnload 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.

 

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