Breyanzi

What is Breyanzi?

Breyanzi is used to treat 5 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), with relapsed or refractory (R/R) marginal zone lymphoma (MZL) 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. The most recent approval was for relapsed or refractory marginal zone lymphoma (MZL) on December 4, 2025.

What is Breyanzi used for?

Breyanzi is FDA-approved to treat five 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), and relapsed or refractory (R/R) marginal zone lymphoma (MZL)  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. 
• This is an accelerated FDA approval.

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. 
• This is an accelerated FDA approval.

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.

Relapsed or refractory (R/R) marginal zone lymphoma (MZL)

Breyanzi is approved for adult patients who have received at least two prior lines of systemic therapy.

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 .

How will I receive Breyanzi?

Breyanzi is a one-time cancer treatment made from your own white blood cells. The process takes several weeks and involves collecting, modifying, and then infusing those cells back into your body, with close monitoring for side effects.

Breyanzi is a liquid medicine given intravenously (into a vein) by a doctor or nurse. It is usually given as two infusions over about 30 minutes total as a one-time dose.

Breyanzi treatment process

Step 1: T Cell collection

• T cells, which are a type of white blood cell, are collected using a procedure called leukapheresis (a process that removes white blood cells from the body).

Step 2: T Cell activation

• The collected T cells are sent away and modified so they can better recognize and attack cancer cells.
• This modification process takes about 3–4 weeks.

Step 3: Preparation for infusion

• You will receive chemotherapy medicines a few days before Breyanzi to prepare your body; this is called lymphodepleting chemotherapy.

Step 4: Breyanzi infusion

• The modified cells are then infused back into your body as Breyanzi. Because the treatment is made from your own cells, it must only be given to you.

Step 5: Follow-up

• Your healthcare provider will check if the treatment is working and monitor for side effects.
  You should plan to stay near the treatment center for at least 4 weeks after receiving Breyanzi.

It is very important not to miss your cell collection or treatment appointment

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

Breyanzi has a boxed warning for cytokine release syndrome(CRS), neurologic toxicity, and secondary hematological malignancies.

Cytokine release syndrome (CRS): This is 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.

What should I avoid after receiving Breyanzi?

 Avoid driving or operating machinery for at least 2 weeks after receiving this treatment. This medicine can cause weakness, drowsiness, confusion, problems with memory or coordination, and seizures.

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

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.