Immunotherapy has changed how advanced melanoma is treated, but it doesn’t work for everyone. Even when melanoma responds at first, the cancer can sometimes start growing again.

Tumor-infiltrating lymphocyte (TIL) therapy offers another way to help the immune system fight melanoma. TIL uses immune cells taken from a person’s tumor, grows billions of them in a lab, and returns them to the body to attack cancer.

In 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to lifileucel (Amtagvi), the first cellular therapy approved for a solid tumor. It’s currently the only FDA-approved TIL therapy, although other approaches are being studied in clinical trials.

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Here’s what to know about how TIL therapy works for melanoma, who may benefit, and what to expect from treatment.

What To Expect During TIL Treatment

TIL therapy is a multistep process that takes several weeks. TIL therapy is generally provided at a medical center experienced in cellular therapies and may not be available at every hospital.

First, a surgeon removes a piece of melanoma tumor. The sample goes to a specialized laboratory, where TILs are separated and multiplied into billions of cells.

For lifileucel, manufacturing takes about 22 days, although the total wait before treatment may be longer.

Once the TILs are ready, you’ll receive a short course of chemotherapy with cyclophosphamide and fludarabine. This chemotherapy course is intended to temporarily reduce certain immune cells, creating a better environment for the incoming TILs.

Next, you’ll receive lifileucel as a single IV infusion. Afterward, you’ll receive up to six doses of interleukin-2 (IL-2), a protein that helps activate and support the T cells.

You’ll need to stay in the hospital during part of the process so your care team can watch for complications. Recovery continues after you go home. Over time, your blood cell counts, immune system, and energy levels return to normal.

Who May Benefit From TIL Therapy?

Lifileucel is FDA-approved for adults with unresectable or metastatic melanoma (stage 3 or stage 4) that has progressed after previous treatment. Unresectable means the melanoma can’t be completely removed with surgery. Metastatic melanoma means the cancer has spread to distant areas of the body.

To be eligible for TIL therapy, people must previously have received an immune checkpoint inhibitor that targets PD-1, such as pembrolizumab (Keytruda) or nivolumab (Opdivo). These medications help take a natural “brake” off immune cells so they can attack cancer.

TIL therapy uses a different strategy to mobilize the immune system when melanoma has progressed despite anti-PD treatment.

What Are the Potential Side Effects?

TIL therapy can cause serious side effects. Some may be related to the TIL infusion, while many come from the chemotherapy and IL-2 used during treatment.

Lifileucel carries an FDA boxed warning, the agency’s strongest safety warning. It covers treatment-related death, prolonged, severely low blood cell counts, serious infections, and complications affecting the heart, lungs, and kidneys.

Low blood cell counts are especially common after chemotherapy. They can increase the risk of infection, anemia, bleeding, bruising, tiredness, or shortness of breath. Other possible side effects include:

In one study, some of the most common severe side effects included low platelet counts, anemia, and fever associated with very low levels of infection-fighting white blood cells.

Because some complications can be serious, your medical team will closely monitor your blood counts and organ function. Before treatment, ask which symptoms you should report right away and what to expect during recovery.

Could TIL Therapy Be an Option for You?

TIL therapy provides a new option for some people whose melanoma can’t be completely removed with surgery or has spread and continued growing after other treatments.

It’s an intensive therapy, and eligibility depends on your previous treatments, tumor characteristics, overall health, and ability to undergo the full process.

If you’d like to learn more, talk with your melanoma care team. Your oncologist can explain whether you may qualify for lifileucel and help you weigh the potential benefits and risks. They can also discuss whether a referral to a specialized TIL treatment center or participation in a clinical trial may be an option.