Pronunciation: am-tag-vee
Generic name: lifileucel
Dosage form: suspension for intravenous infusion
Drug class: Miscellaneous antineoplastics

Medically reviewed by Carmen Pope, BPharm. Last updated on Feb 19, 2024.

What is Amtagvi?

Amtagvi (lifileucel) is a type of medicine called “Tumor-derived autologous T cell immunotherapy” that is given as an infusion into your vein (usually in a hospital). It may be used to treat adults with melanoma that:

• cannot be surgically removed or has spread to other parts of the body AND
• has not responded or has stopped responding to a PD-1 blocking drug either by itself or in a combination AND
• if BRAF V600 mutation-positive, has not responded to a BRAF inhibitor with or without a MEK inhibitor.

Amtagvi (lifileucel) is comprised of T cells derived from tissue excised from your tumor. Tumor-derived T cells are cells produced by the body’s immune system that may recognize and kill cancer (tumor) cells, although the exact way Amtagvi works is unknown.

Amtagvi was FDA-approved under the accelerated approval scheme on February 14, 2024. Continued approval may be contingent upon continued clinical benefit as confirmed in clinical trials.

Warnings

Administration of Amtagvi may cause an allergic reaction including anaphylaxis.

Deaths, due to severe infections, internal organ hemorrhage, acute kidney failure, and other reactions have been reported after the administration of Amtagvi. The rate in clinical trials was 7% of those administered it within 150 days of the infusion.

Grade 3 or higher cytopenia for weeks or longer and febrile neutropenia have been reported in 45.5% and 46.8% respectively of melanoma patients administered Amtagvi. Your healthcare provider will monitor your blood counts after the infusion.

Internal organ bleeding, such as within the abdomen or skull, has been reported after Amtagvi administration. Patients with persistent or repeated low platelet counts (thrombocytopenia) following the infusion should not receive anticoagulants or must be under close monitoring if they must take them.

Severe, life-threatening, or fatal infections have occurred after Amtagvi administration. Amtagvi should not be administered to patients with clinically significant systemic infections and your healthcare provider may administer prophylactic antibiotics and will monitor you for signs and symptoms of an infection before and after the infusion and treat appropriately.

Acute infusion reactions may occur within 1 day of infusion and include fever, rigors or chills, tachycardia (fast heart rate), rash, hypotension (low blood pressure), dyspnea (shortness of breath), cough, chest tightness, and wheezing. These usually resolve on the same day of infusion. Your healthcare provider will monitor you during and after your infusion for signs and symptoms of a severe reaction, and treat promptly.

Worsened respiratory and kidney function which may be fatal have also been associated With Amtagvi. Your healthcare provider will monitor you for these.

Before taking

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
• 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 blood thinner
• Are pregnant, think you may be pregnant, or plan to become pregnant
• Are breastfeeding.

Pregnancy

Females of reproductive potential who are sexually active should have a pregnancy test before starting treatment with Amtagvi.

There are no data on the effect of Amtagvi on fertility.

Breastfeeding

There is no information regarding the presence of Amtagvi in human milk, the effect on the breastfed infant, and the effects on milk production.

How Is Amtagvi administered?

You will likely be in a hospital before and after receiving Amtagvi.

Amtagvi is made from tumor tissue after your tumor (or tumors) has been surgically removed.

• The tissue is sent to a specialized manufacturing center which separates out tumor-derived T cells and grows them until they number in the billions. 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 to 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 receive Amtagvi, your healthcare provider may give you an antihistamine (to reduce the risk of an allergic reaction) and/or acetaminophen (to help with fever).
• When your body is ready for Amtagvi, your healthcare provider will give it to you via intravenous infusion (an infusion into your brain).
• Amtagvi is provided in 4 infusion bags, and it takes less than 90 minutes to infuse all 4 bags.

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 if you present severe side effects.
• You will have to stay in the hospital until you have completed the IL-2 (aldesleukin) treatment and 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 side effects of Amtagvi?

Amtagvi may cause serious side effects, some of which may be life-threatening, such as:

• Treatment-related mortality
• Prolonged severe cytopenia
• Internal organ hemorrhage
• Severe infection
• Cardiac disorder
• Respiratory failure
• Acute renal failure
• Hypersensitivity reactions.

Common side effects of the Amtagvi affecting 20% or more people include:

• Chills
• Fever (100.4°F (38°C) or higher)
• Low white blood cell count (may increase risk of infections)
• Low platelets (may increase the risk of bleeding)
• Fatigue
• Low red blood cell count (may cause you to feel tired or weak)
• Fast or irregular heartbeat
• Rash
• Low blood pressure
• Diarrhea
• Edema
• Hair loss
• Infection
• Low oxygen levels
• Shortness of breath.

These are not all the possible side effects of the Amtagvi treatment. If you would like more information talk with your healthcare provider. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

What other drugs will affect Amtagvi?

Tell your healthcare provider about all your medications, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Patients with persistent or repeated low platelet counts (thrombocytopenia) after receiving Amtagvi should not use anticoagulants or must be under close monitoring if they must take them.

See the Amtagvi Product Information for a complete list of interactions.

Storage

Amtagvi is shipped directly to the treatment center in the vapor phase of a liquid nitrogen cryoshipper. Store Amtagvi frozen in the vapor phase of liquid nitrogen (less than or equal to minus 150°C).

Match the identity of the patient with the patient identifiers on the cassette(s) and infusion bag(s) upon receipt.

Ingredients

Active: Tumor-derived T cells of the CD4+T and CD8+T cell lineages. May also contain monocytes; other lymphocytes, including B cells and NK cells; and viable melanoma tumor cells from the original tumor tissue used to manufacture the product.

Inactive: 48% PlasmaLyte A, 50% CryoStor CS10 (resulting in a final concentration of 5% dimethyl sulfoxide (DMSO)), 2% of 25% human serum albumin (resulting in a final concentration of 0.5% albumin), and 300 IU/mL IL-2 (aldesleukin).

A single dose is provided in 1 to 4 infusion bag(s) containing 100 mL to 125 mL of viable cells per bag (7.5 x 10⁹ to 72 x 10⁹) in individual protective cassettes.

Manufacturer

Iovance Biotherapeutics Manufacturing LLC.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer