Powering your treatment with your cells

AMTAGVI™ is different from other Immunotherapy:
Treatment that uses a person's own immune system to fight cancer. Immunotherapy can boost or change how the immune system works so it can find and attack cancer cells. you may have tried in the past.

AMTAGVI is a one-time treatment made from cells created by your immune system when it detects cancer.

An introduction to AMTAGVI

Understanding T cells

What are T cells?

Your immune system plays an important role in helping to keep your body healthy and free from diseases such as infections and cancer.

When cancer is detected, it naturally responds by sending specialized Immune cell:
A cell that is part of the immune system and helps the body fight infections and other diseases. known as T cells.

An abstract image of four people, showing the uniqueness of cells.An abstract image of four people, showing the uniqueness of cells.

AMTAGVI is unique to each patient

The AMTAGVI treatment process multiplies your unique T cells to create the one-time treatment that may help fight your previously treated melanoma that has spread or cannot be removed by surgery.

FIND OUT IF AMTAGVI MAY BE RIGHT FOR YOU

How AMTAGVI is made–it starts with you

AMTAGVI is a one-time, individualized treatment that takes about 1 month to make.*

Every person and their cells are different, and the time it takes to make your one-time AMTAGVI treatment may vary for every person.

Tumor tissue

A small piece of your tumor is surgically removed and shipped to a specialized manufacturing facility.

Separating T cells

At the specialized facility, the T cells are separated from your tumor.

Multiplying T cells

The separated T cells are rejuvenated and then grown into the billions.†

AMTAGVI

These steps—when completed—will produce your one-time AMTAGVI.*

*Learn more about each step of AMTAGVI.

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

AMTAGVI is available at Authorized Treatment Centers:
Specialized hospitals where healthcare teams are trained and equipped to provide AMTAGVI. and must be given by trained healthcare teams.

Locate an Authorized treatment Center near you

Details about the AMTAGVI treatment process

LEARN MORE ABOUT RECEIVING AMTAGVI

Your cells.
Your results.

See treatment outcomes

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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