Key takeaways

  • Breyanzi is a cell-based immunotherapy approved for treating certain kinds of B-cell lymphoma in adults. It’s used in situations where cancer has come back after past treatment or is not responding to treatment.
  • Breyanzi is given as a one-time intravenous (IV) infusion in a hospital.
  • More common side effects of Breyanzi include fever, muscle pain, headache, nausea, and cytokine release syndrome.

Specifically, Breyanzi is used in certain adults to treat:

Breyanzi is only used for these types of cancer in certain situations. To learn more about Breyanzi’s uses, see the “Uses for Breyanzi” section.

Breyanzi basics

Breyanzi contains the active ingredient lisocabtagene maraleucel. It’s a type of treatment called chimeric antigen receptor T-cell (CAR T-cell) therapy.

Breyanzi is a biologic product. A biologic is made from parts of living organisms. Breyanzi is made by collecting T cells (a type of white blood cell) from your blood and altering them in a lab.

Breyanzi is available only as a brand-name medication. It isn’t available in a generic or biosimilar form. (Just as generic drugs can be an alternative to brand-name medications, biosimilars are an effective alternative to biologics.)

Breyanzi has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Breyanzi precautions” section.

Breyanzi is used to treat certain types of lymphoma in adults in some situations. Specifically, Breyanzi is used to treat:

  • large B-cell lymphoma, when any of the following apply:
    • the first treatment hasn’t worked
    • the cancer has come back within 1 year after the first treatment
    • the cancer has come back after the first treatment and hematopoietic stem cell transplant isn’t an option
    • two or more treatments haven’t worked
    • the cancer has come back after two or more treatments have stopped working
  • chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (see “Note” below), when:
    • two or more treatments (including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitor) haven’t worked, or
    • the cancer has come back after two or more of these treatments have stopped working
  • follicular lymphoma (see “Note” below), when:
    • two or more treatments haven’t worked, or
    • the cancer has come back after two or more treatments have stopped working
  • mantle cell lymphoma, when:
    • two or more treatments (including a Bruton tyrosine kinase inhibitor) haven’t worked, or
    • the cancer has come back after two or more of these treatments have stopped working

These types of lymphoma affect white blood cells called B cells. The cancerous B cells increase in numbers and crowd out healthy blood cells. These types of cancer can cause symptoms such as swollen lymph nodes, night sweats, loss of appetite, weight loss, and low energy.

What Breyanzi does

Breyanzi is a type of treatment called CAR T-cell therapy, which is a form of immunotherapy. Immunotherapy helps your immune system attack cancer cells.

Breyanzi is made from immune cells called T cells that are collected from your blood. Your doctor sends them to a laboratory, where they are programmed to attach to a particular protein found on cancerous B cells. The lab makes large numbers of the programmed T cells. Your doctor then injects these back into your blood, where they attach to the cancerous B cells. This helps your immune system attack and kill the cancer cells.

The way Breyanzi works is called its mechanism of action.

Breyanzi has a limitation of use. Doctors do not prescribe it to treat primary central nervous system lymphoma, which occurs when cancer cells form in the lymph tissue of the brain and/or spinal cord.

Note: Breyanzi received accelerated approval from the FDA for CLL/SLL and follicular lymphoma. The FDA uses accelerated approval to speed up access to certain treatments for conditions with few treatment options. The FDA approval is based on successful results from early clinical studies. After further studies are completed, the FDA will decide whether to grant full approval to the treatment for that use.

Like most drugs, Breyanzi may cause mild to serious side effects. The following lists contain some of the more common side effects Breyanzi may cause, but they don’t include all possible side effects.

Keep in mind that side effects of a drug can depend on:

  • your age
  • other health conditions you have
  • other medications you take

Your doctor or pharmacist can tell you more about the potential side effects of Breyanzi. They can also suggest ways to help reduce side effects.

Note: After the FDA approves a drug, it tracks and reviews side effects of the medication. Sharing your experience helps make medications safer for everyone by giving doctors and researchers more information about how the drug works in real life. If you develop a side effect during treatment with Breyanzi and want to tell the FDA about it, visit MedWatch or call 800-FDA-1088.

Mild side effects

Here’s a list of some of the mild side effects that Breyanzi can cause. To learn about other mild side effects, talk with your doctor or pharmacist, or read Breyanzi’s prescribing information.

Mild side effects of Breyanzi that have been reported include:

Mild side effects of many drugs may go away within a few days to a couple of weeks. But if they become bothersome, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Breyanzi can occur, but they aren’t common. If you have serious side effects from Breyanzi, call your doctor right away. If you think you’re having a medical emergency, you should call 911 or your local emergency number.

Serious side effects of Breyanzi that have been reported include:

  • low levels of white blood cells, red blood cells, and platelets (cells that help blood clot) that may last for a long time after receiving Breyanzi
  • low levels of antibodies
  • serious infections
  • boxed warnings: risk of cytokine release syndrome, neurologic toxicity (brain and nerve problems), and new blood cancers

For more information about side effects related to boxed warnings, see the “Breyanzi precautions” section.

Allergic reaction

For some people, Breyanzi can cause an allergic reaction.

In general, symptoms of an allergic reaction can be mild or serious.

What might help

If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may suggest a treatment to manage your symptoms and can determine whether you should continue Breyanzi treatment.

If you have symptoms of a severe allergic reaction, such as swelling or difficulty breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

If your doctor confirms you’ve had a serious allergic reaction to Breyanzi, they may have you switch to a different treatment.

Note: Before your infusion, your doctor will likely give you medications to help prevent a reaction. Examples include acetaminophen (Tylenol) and diphenhydramine (Benadryl).

Breyanzi is given as a one-time treatment. Your doctor will determine the best dosage to fit your needs.

Form

Breyanzi is a type of CAR T-cell therapy. It’s made from T cells collected from your blood and altered in a lab.

Breyanzi comes as a suspension of cells given by intravenous (IV) infusion (an injection into your vein over a period of time). You’ll receive this treatment in the hospital. (A suspension is a type of liquid mixture.)

Recommended dosage

Your doctor will prescribe the dosage of Breyanzi that’s right for you.

Before receiving Breyanzi, you’ll receive a 3-day course of chemotherapy to lower the number of other immune cells in your blood. This helps Breyanzi work better.

You’ll typically receive Breyanzi the week after having chemotherapy. At your appointment, you’ll receive medications to help reduce the risk of side effects with Breyanzi. Then you’ll receive two infusions of Breyanzi, one right after the other. Each infusion contains a different type of altered T cell. Each infusion usually takes about 15 minutes.

About receiving Breyanzi

The following are some common questions about Breyanzi treatment.

  • Will I need to use Breyanzi long term? No, Breyanzi is a one-time treatment.
  • How long does Breyanzi take to work? Breyanzi begins to work right after you receive your infusion. But you likely won’t feel it working in your body. Your doctor will order tests to check whether Breyanzi is working to treat your condition.

Breyanzi is not known to interact with other medications, herbs, supplements, foods, or alcohol. The manufacturer did not list any interactions in the drug’s prescribing information.

However, before starting Breyanzi treatment, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you take. Sharing this information can help you avoid potential interactions.

Breyanzi can interact with certain lab tests and vaccines, including:

  • live vaccines, such as the chickenpox vaccine (Varivax), measles, mumps, and rubella (MMR) vaccine, or the nasal spray flu vaccine (FluMist)
  • some HIV tests

This list does not contain all lab tests and vaccines that may interact with Breyanzi. If you have questions about interactions that may affect you, ask your doctor or pharmacist.

Whether you have health insurance or not, cost may be a factor when you’re considering Breyanzi. What you’ll pay for Breyanzi may depend on several things, such as your treatment plan and the pharmacy you use. Your doctor or pharmacist can give you more information about how much Breyanzi treatment costs.

Here are a few things to consider regarding cost:

  • Cost information and savings coupons: You may be able to find drug coupons on prescription discount websites that can reduce the cost of your medication. These coupons cannot be used with insurance copays or benefits, but the discounted price may be lower than what you would pay through insurance.
  • Savings program: If you have questions about how to pay for Breyanzi, talk with your doctor or pharmacist. A program called Cell Therapy 360 may also be available.

The following is important information to consider and discuss with your doctor or pharmacist before receiving Breyanzi.

Pregnancy and Breyanzi

It’s not known whether Breyanzi is safe to receive during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before receiving this treatment.

Birth control and Breyanzi

It’s not known whether Breyanzi is safe to receive during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control options before and after receiving Breyanzi.

Breyanzi and breastfeeding

It’s not known whether Breyanzi is safe to receive while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before receiving this treatment.

This section describes the warnings and precautions for Breyanzi.

FDA warnings

Breyanzi has boxed warnings about the risk of certain side effects. A boxed warning is the most serious warning from the Food and Drug Administration (FDA) about drug effects that may be dangerous.

Breyanzi’s boxed warnings include:

  • Risk of new blood cancers: Breyanzi may increase your risk of developing new blood cancers. Your doctor will monitor you for signs and symptoms of new cancers after you receive Breyanzi.
  • Risk of cytokine release syndrome: Breyanzi can cause cytokine release syndrome (CRS), a serious immune system reaction that can be life threatening. It’s sometimes called a cytokine storm. Symptoms can include fever, shivering, dizziness, fast heart rate, shortness of breath, and headache.
  • Risk of neurologic toxicity: Breyanzi can cause brain and nerve problems, such as seizures and swelling in the brain. These problems can be life threatening. Symptoms can include confusion, tremors, headache, trouble speaking, and severe sleepiness.

Due to the risk of CRS and neurologic toxicity, you should stay close to the hospital where you receive Breyanzi for at least 2 weeks after your treatment. You should also avoid driving during this time.

Your doctor will monitor you daily for at least the first week after you receive Breyanzi. Be sure to call your doctor right away if you have any symptoms of CRS or neurologic toxicity.

If you have questions or concerns about these warnings, talk with your doctor.

Other precautions

Before receiving Breyanzi, discuss your health history with your doctor. Breyanzi may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

Note: For more information about the potential negative effects of Breyanzi, see the “Side effects of Breyanzi” section.

Here are answers to some commonly asked questions about Breyanzi.

Who is the manufacturer of Breyanzi?

Each individual Breyanzi treatment is manufactured by Juno Therapeutics at its laboratory in Bothell, Washington. Juno Therapeutics is owned by Bristol Myers Squibb. Breyanzi is manufactured specifically for each person prescribed the treatment using their immune cells. To learn more about this process, see the “Uses of Breyanzi” section earlier in the article.

What is the success rate of Breyanzi?

The success rate of Breyanzi may vary depending on the condition you receive it for. But in studies, the majority of people who received Breyanzi had reduced or no signs of cancer after having the treatment. Breyanzi was also found to increase the length of time people lived without their cancer getting worse or coming back.

Keep in mind that results can vary between people and may be different from those in studies. The results you may have with Breyanzi can depend on several factors. These include the type of cancer you have, other treatments you’ve had, other conditions you may have, and side effects with Breyanzi.

To find out more about what to expect with Breyanzi treatment, talk with your doctor.

Other CAR T-cell therapies are available that can treat your condition. If you’d like to explore an alternative to Breyanzi, talk with your doctor. They can tell you about other treatments that might work well for you.

The following CAR T-cell therapies are similar to Breyanzi:

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.