Pronunciation: braye an' zee
Generic name: lisocabtagene maraleucel
Dosage form: suspension for intravenous infusion
Drug class: Miscellaneous antineoplastics

Medically reviewed by Melisa Puckey, BPharm. Last updated on Mar 18, 2024.

What is Breyanzi?

Breyanzi is used to treat certain large B-cell lymphoma, relapsed or refractory chronic lymphocytic leukemia (CLL), or small lymphocytic lymphoma (SLL), which are types of cancer of white blood cells. Breyanzi is a CAR T-cell therapy that is prepared using cells from the patient's own blood; the T cells are changed and then delivered as a one-time infusion back into the patient. Breyanzi works as the changed T cells attached to the cancer cells and kill them, helping clear the cancer from the body.

Breyanzi FDA approval was received on February 5, 2021, for types of Relapsed or Refractory Large B-cell Lymphoma. FDA approval was extended on June 24, 2022 and again on March 14, 2024 to include more indications. 

What is Breyanzi used for?

Breyanzi for large B-cell lymphoma (LBCL)

Breyanzi (lisocabtagene maraleucel) is specifically used to treat adults that have large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B. You can only be treated with Breyanzi if:

• your first treatment has not worked, or your cancer returned within a year of your first treatment OR
• your first treatment has not worked, or your cancer returned after the first treatment, and you are not eligible for hematopoietic stem cell transplantation because of medical conditions or age OR
• two or more kinds of treatment have not worked or stopped working.

Breyanzi for relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

Breyanzi is specifically used to treat adults who have relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have:

• received at least 2 prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor.

Breyanzi side effects

Breyanzi side effects may include constipation, stomach pain, loss of appetite, rash, numbness, pain, tingling, or burning feeling in feet or hands. Tell your doctor if any of these symptoms are severe or do not go away.

Serious Breyanzi side effects

Some Breyanzi side effects can be serious. If you experience any of these symptoms or those listed in the Warning section, call your doctor immediately or get emergency medical treatment:

• feeling tired
• bruising or bleeding
• fever, sore throat, chills, or other signs of infection
• confusion
• fast or irregular heartbeat.

Breyanzi may increase your risk of developing certain cancers. Talk to your doctor about the risks of receiving this medication. This medication may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ([WEB]) or by phone (1-800-332-1088).

How will I receive Breyanzi?

Breyanzi is a suspension (liquid) injected intravenously (into a vein) by a doctor or nurse in a doctor's office or infusion center. It is usually given as two infusions over a total period of up to 30 minutes as a one-time dose. Before you receive this medicine your doctor or nurse will administer other chemotherapy medications to prepare your body for Breyanzi treatment.

The Breyanzi procedure first starts with the collection of your white blood cells at a cell collection center using a procedure called leukapheresis (a process that removes white blood cells from the body). The white cells are sent away, where they are modified so that they are able to recognize and attack the cancer cells, this takes 3 or 4 weeks.  These modified white cells are given to you as an infusion. Three days before your infusion, you will have chemotherapy to prepare your body for your treatment. Because this medication is made from your own cells, it must be given only to you. It is important to be on time and not miss your scheduled cell collection appointment(s) or to receive your treatment dose. You should plan to stay near where you received your Breyanzi treatment for at least 4 weeks after your dose.

Your healthcare provider will check to see if your treatment is working and monitor you for any possible side effects. Talk to your doctor about how to prepare for leukapheresis and what to expect during and after the procedure.

What should I tell my doctor before receiving Breyanzi?

Before receiving Breyanzi:

• Tell your doctor and pharmacist if you are allergic to Breyanzi, any other medications, or any of the ingredients in lisocabtagene maraleucel. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change your medication doses or monitor you carefully for side effects.
• Tell your doctor if you have or have ever had hepatitis B virus or liver disease.
• Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You will need to have a pregnancy test before you start this medicine. If you become pregnant while receiving this medicine, call your doctor immediately.

Warnings

Breyanzi may cause a serious or life-threatening reaction called cytokine release syndrome (CRS). A doctor or nurse will monitor you carefully during your infusion and for at least 4 weeks afterwards. Tell your doctor if you have an inflammatory disorder or if you have or think you may have any type of infection now. You will be given medications 30 to 60 minutes before your infusion to help prevent reactions to lisocabtagene maraleucel. If you experience any of the following symptoms during and after your infusion, tell your doctor immediately: fever, chills, fast or irregular heartbeat, muscle pain, shaking, diarrhea, tiredness, weakness, difficulty breathing, shortness of breath, cough, confusion, nausea, vomiting, dizziness, or lightheadedness.

Breyanzi may cause severe or life-threatening central nervous system reactions. These reactions can occur after treatment with this medicine. Tell your doctor if you have or have ever had seizures, a stroke, or memory loss. If you experience any of the following symptoms, tell your doctor immediately: headache, dizziness, difficulty falling asleep or staying asleep, restlessness, confusion, anxiety, uncontrollable shaking of a part of the body, loss of consciousness, agitation, seizures, loss of balance, or difficulty speaking.

Breyanzi REMS

Breyanzi is only available through a special restricted distribution program. A Breyanzi  REMS program (Risk Evaluation and Mitigation Strategy) has been set up because of the risks of CRS and neurological toxicities. You can only receive the medication from a doctor and healthcare facility that participates in the program. Ask your doctor if you have any questions about this program.

Special Precautions

Important precautions that you should be aware of are:

• that Breyanzi may make you drowsy and cause confusion, weakness, dizziness, seizures, and coordination problems. Do not drive a car or operate machinery for at least 8 weeks after your last dose.
• do not donate blood, organs, tissues, or cells for transplantation after you receive this medicine.
• check with your doctor to see if you need to receive any vaccinations. Do not have any vaccinations without talking to your doctor for at least 6 weeks before starting chemotherapy, during your Breyanzi treatment, and until your doctor tells you that your immune system has recovered.

Interactions

Other drugs may affect this medicine, including prescription and over-the-counter medicines, vitamins, and herbal products. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

To check for interactions with Breyanzi, click on the link below.

Breyanzi Package Insert 

Review the Breyanzi Package Insert for more detailed information about this medicine. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

What other information should I know while taking Breyanzi?

• Keep all appointments with your doctor, the cell collection center, and the laboratory. Your doctor may order certain lab tests before, during, and after your treatment to check your body's response to this medicine.
• Before having any laboratory test, tell your doctor and the laboratory personnel that you are receiving this medicine.
• Ask your pharmacist, doctor or healthcare provider any questions you have about Breyanzi.

Breyanzi Manufacturer

Manufactured by:

Juno Therapeutics Inc., a Bristol-Myers Squibb Company, Bothell, WA 98021. US License No.: 2156

Celgene Corporation, a Bristol-Myers Squibb Company, Summit, NJ 07901. US License No.: 2252.

Bristol-Myers Squibb Company, Devens, MA 01434. US License No.: 1713.
BREYANZI® is a trademark of Juno Therapeutics, Inc., a Bristol-Myers Squibb Company.

Further information

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

Medical Disclaimer