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 Jun 10, 2024.

What is Breyanzi?

Breyanzi is used to treat types of non-Hodgkin lymphoma, including large B-cell lymphoma (LBCL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), follicular lymphoma (FL), and relapsed or refractory mantle cell lymphoma (MCL), in specific patients.

Breyanzi is a one-time infusion of CAR T cell therapy that may help you have complete and lasting remission. 

Breyanzi is a cancer treatment created using immune cells, called T cells, collected from the patient's own blood. The T cells are modified to become CAR T cells and are then infused back into the patient's body. The CART T cells can attach to the cancer cells and kill them, helping clear the cancer from the body.  Before your infusion, you will have chemotherapy to prepare your body for your treatment. 

Breyanzi FDA approval was first received on February 5, 2021, for the company Bristol Myers Squibb (BMS).  It contains lisocabtagene maraleuce.

What is Breyanzi used for?

Breyanzi is FDA-approved to treat four types of non-Hodgkin lymphoma: large B-cell lymphoma, relapsed or refractory chronic CLL/SLL, relapsed or refractory follicular lymphoma (FL), and relapsed or refractory mantle cell lymphoma (MCL) in specific patients.

Large B-cell lymphoma

Breyanzi is used to treat 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, in adults. 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.

It is not indicated for the treatment of primary central nervous system lymphoma.

Relapsed or refractory chronic CLL/SLL

Breyanzi is used to treat relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults 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.

Relapsed or refractory follicular lymphoma (FL) 

Breyanzi is used to treat relapsed or refractory follicular lymphoma (FL) in adults who have:

• received 2 or more prior lines of systemic therapy. 

Relapsed or Refractory Mantle Cell Lymphoma (MCL)

It is approved for treating adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor.

Breyanzi side effects

Common Breyanzi side effects

Common Breyanzi side effects may include:

• headache, dizziness;
• confusion, problems with speech or thinking;
• fever, chills, shaking;
• nausea, vomiting, stomach pain;
• diarrhea, constipation;
• fast or irregular heartbeats;
• cough, trouble breathing;
• swelling; or
• pain in your bones, joint, or muscles.

Serious Bryanzi side effects

Get emergency medical help if you have signs of an allergic reaction, hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

A common but serious side effect of this medicine is called cytokine release syndrome (CRS). Tell your caregivers right away if you have signs of this condition: fever, chills, dizziness, confusion, vomiting, diarrhea, fast heartbeats, trouble breathing, or feeling very weak or tired. Your caregivers will have medication available to treat CRS if it occurs.

Breyanzi may cause other serious side effects. Call your doctor at once if you have:

• problems with speech;
• confusion, trouble concentrating, memory problems;
• decreased consciousness;
• tremors, or a seizure; or
• signs of infection - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

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 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 can 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.

This treatment should only be administered in a REMS-certified healthcare facility.

Before taking this medicine

Tell your doctor if you have ever had:

• hepatitis B or C; or
• if you have received a vaccine within the past 6 weeks.

Using Breyanzi may increase your risk of developing other cancers. Ask your doctor about this risk.

Tell your doctor if you are pregnant or breastfeeding.

You may need to have a negative pregnancy test before starting this treatment.

Warnings

A common but serious side effect of this medicine is called cytokine release syndrome, which causes fever, chills, trouble breathing, vomiting, and other symptoms. Your caregivers will have medication available to treat this condition if it occurs.

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.

T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including this therapy.

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 participating in the program. Ask your doctor if you have any questions about this program.

What should I avoid after receiving Breyanzi?

This medicine can cause weakness, drowsiness, confusion, problems with memory or coordination, and seizures. Avoid driving or operating machinery for at least 8 weeks after treating you with this treatment.

Do not donate blood, organs, tissues, or cells for transplantation.

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 your immune system has recovered.

What other drugs will affect Breyanzi?

Other drugs may affect this medicine, including prescription and over-the-counter medicines, vitamins, and herbal products. You should keep a written list of all the prescription and nonprescription (over-the-counter) medicines you take, along with any products such as vitamins, minerals, or other dietary supplements. Remember to bring this list with you each time you see a doctor or are hospitalized. This information is important to have on hand for 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 with your doctor or other health care provider. This is not all the information you need about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

Company

Breyanzi is 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