Breyanzi (Lisocabtagene Maraleucel)
CAR T-cell therapy for B-cell lymphoma
Quick facts about Breyanzi
Key takeaways about Breyanzi
- Personalized therapy: Breyanzi is made from your own white blood cells, genetically modified to target and kill lymphoma cells expressing the CD19 protein.
- One-time treatment: Unlike conventional chemotherapy, Breyanzi is given as a single infusion, though the entire process from cell collection to infusion takes several weeks.
- Serious side effects possible: Cytokine release syndrome (CRS) and neurotoxicity (ICANS) are significant risks that require close monitoring at certified treatment centers.
- Multiple lymphoma types: Approved for diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma.
- Post-treatment monitoring: Patients must remain near the treatment center for at least 2 weeks after infusion and should not drive for at least 4 weeks.
What Is Breyanzi and What Is It Used For?
Breyanzi (lisocabtagene maraleucel) is an autologous anti-CD19 CAR T-cell therapy used to treat adults with certain types of relapsed or refractory B-cell non-Hodgkin lymphoma. It represents a revolutionary approach to cancer treatment that harnesses the patient's own immune system to fight cancer.
Breyanzi belongs to a class of treatments known as chimeric antigen receptor (CAR) T-cell therapies. Unlike traditional cancer treatments such as chemotherapy or radiation that directly attack cancer cells, CAR T-cell therapy works by reprogramming the patient's own immune cells. The treatment involves collecting white blood cells (specifically T-cells) from the patient's blood through a process called leukapheresis, genetically modifying these cells in a specialized laboratory, and then infusing them back into the patient.
The genetic modification involves inserting a gene that encodes a chimeric antigen receptor (CAR) into the T-cells. This receptor is specifically designed to recognize and bind to a protein called CD19, which is found on the surface of B-cells, including the cancerous B-cells in lymphoma. When the modified T-cells encounter CD19-expressing cancer cells, they activate and mount a powerful immune response against the tumor.
What makes Breyanzi unique among CAR T-cell products is its defined composition approach. The treatment consists of two separate components: CD8-positive T-cells (cytotoxic T-cells that directly kill cancer cells) and CD4-positive T-cells (helper T-cells that support the immune response). These are administered sequentially as separate infusions, which is designed to provide a more consistent and predictable therapeutic effect compared to products with variable cell compositions.
Approved Indications
Breyanzi has received regulatory approval from both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) for the treatment of adults with the following types of B-cell lymphoma:
- Diffuse large B-cell lymphoma (DLBCL): The most common type of aggressive non-Hodgkin lymphoma, accounting for approximately 30–40% of all NHL cases worldwide.
- High-grade B-cell lymphoma: An aggressive form of lymphoma that may have features of both DLBCL and Burkitt lymphoma.
- Primary mediastinal large B-cell lymphoma (PMBCL): A subtype of DLBCL that originates in the mediastinum (the area between the lungs).
- Follicular lymphoma (FL): A slow-growing lymphoma that can transform into a more aggressive form.
- Mantle cell lymphoma (MCL): A relatively rare B-cell lymphoma that often requires intensive treatment.
In most cases, Breyanzi is used as a second-line or later treatment, meaning it is given to patients whose cancer has not responded to previous therapies (refractory disease) or has come back after initial treatment (relapsed disease). In certain settings, such as DLBCL, it may also be used as a second-line therapy for patients who relapse within 12 months of first-line treatment or are refractory to first-line therapy.
Breyanzi uses a defined-composition approach, delivering separate CD8+ and CD4+ T-cell components at specified doses. This design aims to provide more consistent efficacy and a potentially better safety profile compared to other CAR T-cell products that deliver a mixed, variable composition of T-cell subtypes.
What Should You Know Before Receiving Breyanzi?
Before receiving Breyanzi, your healthcare team will conduct extensive evaluations including cardiac, pulmonary, and infectious disease screening. Certain conditions such as active infections, recent stem cell transplants, or pregnancy may affect your eligibility for treatment.
Breyanzi is a powerful immunotherapy that requires careful patient selection and preparation. Your healthcare team at the certified treatment center will conduct a thorough evaluation before determining whether Breyanzi is appropriate for you. This comprehensive assessment helps ensure the safest and most effective treatment outcome.
Contraindications
You should not receive Breyanzi if:
- You are allergic to any of the ingredients in Breyanzi, including dimethyl sulfoxide (DMSO). If you suspect you may have an allergy to any component, discuss this with your healthcare provider before treatment.
- You cannot receive lymphodepleting chemotherapy. Before Breyanzi is infused, you must receive a short course of chemotherapy (known as lymphodepleting conditioning) to prepare your body for the modified T-cells. If you are unable to tolerate this preparatory treatment, Breyanzi cannot be administered.
Warnings and Precautions
Before treatment, inform your healthcare provider about all of the following conditions, as they may affect your treatment plan or require additional monitoring:
- Heart or lung problems: These conditions may increase the risk of complications during and after treatment, particularly in the context of cytokine release syndrome.
- Low blood pressure: Hypotension can be worsened by CRS and may require additional intervention.
- Active infections or inflammatory conditions: Any existing infection will need to be treated and resolved before Breyanzi can be administered, as the lymphodepleting chemotherapy and the therapy itself can significantly suppress the immune system.
- Previous allogeneic stem cell transplant (within 4 months): If you have received a stem cell transplant from another person within the past 4 months, you may be at increased risk for graft-versus-host disease (GvHD), a condition where the transplanted cells attack your body.
- Worsening cancer symptoms: Fever, weakness, night sweats, or unexpected weight loss should be reported immediately.
- History of hepatitis B, hepatitis C, or HIV: These infections require special consideration and may need to be managed before and during treatment.
- Recent vaccination (within 6 weeks) or planned vaccination: Live vaccines should not be given during a specific window around treatment.
Patients treated with Breyanzi and similar CAR T-cell products have developed new cancers originating from T-cells. Report any new swelling in lymph nodes, skin changes, new rashes, or lumps to your healthcare provider immediately. Long-term follow-up monitoring is essential.
Pre-Treatment Tests and Evaluations
Before you receive Breyanzi, your healthcare team will perform several important assessments:
- Lung function tests, cardiac evaluation, and blood pressure monitoring
- Screening for active infections, which must be treated before proceeding
- Assessment for graft-versus-host disease if you have had a prior allogeneic transplant
- Blood uric acid levels and tumor burden assessment to evaluate the risk of tumor lysis syndrome (TLS)
- Screening for hepatitis B, hepatitis C, and HIV infection
- Evaluation of disease status to ensure cancer has not progressed to a point where treatment cannot proceed safely
Pregnancy and Breastfeeding
The effects of Breyanzi on pregnant or breastfeeding women are not known. The treatment could potentially harm an unborn or nursing child. A pregnancy test will be required before treatment begins, and Breyanzi will only be given if the result is negative.
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, you should discuss this with your healthcare provider before receiving Breyanzi or the lymphodepleting chemotherapy. Your doctor will discuss the need for contraception both during and after treatment. If you believe you may have become pregnant after receiving Breyanzi, contact your healthcare provider immediately.
Driving and Operating Machinery
You must not drive any vehicle, operate machinery, or participate in any activity requiring alertness or concentration for a minimum of 4 weeks after receiving Breyanzi. The treatment can cause drowsiness, decreased consciousness, confusion, and seizures. Depending on your individual response, your healthcare provider may recommend extending this restriction period.
Important Drug Interactions
Certain medications can affect how well Breyanzi works. Before treatment, inform your healthcare provider about all medications you are taking, including over-the-counter medicines and supplements.
- Immunosuppressants (corticosteroids): Medications that weaken the immune system, such as corticosteroids, may reduce the effectiveness of Breyanzi. Inform your healthcare team if you are taking any immunosuppressive drugs.
- Other cancer treatments: Some anticancer drugs may interfere with Breyanzi. Your oncologist will assess whether other cancer therapies need to be modified or discontinued.
- Live vaccines: Live vaccines must not be given for 6 weeks before lymphodepleting chemotherapy, during Breyanzi treatment, or after treatment until your immune system has recovered. Discuss all vaccination plans with your healthcare provider.
How Does Breyanzi Interact with Other Drugs?
Breyanzi's effectiveness can be reduced by immunosuppressive medications, particularly corticosteroids and certain cancer drugs. Live vaccines are contraindicated around the time of treatment, and all current medications should be reviewed with your healthcare team.
Because Breyanzi is a living cell therapy rather than a conventional pharmaceutical drug, its interaction profile differs from traditional medications. The modified T-cells must be able to survive, expand, and function within the patient's immune system. Any medication that suppresses or alters immune function can potentially interfere with this process.
Your healthcare team will conduct a thorough medication review before treatment. In some cases, medications may need to be adjusted, paused, or discontinued to ensure optimal outcomes with Breyanzi. The following table summarizes key drug interactions to be aware of.
| Drug / Drug Class | Interaction Type | Clinical Significance | Recommendation |
|---|---|---|---|
| Corticosteroids (prednisone, dexamethasone) | Immunosuppression | May reduce CAR T-cell expansion and efficacy | Avoid before and after infusion unless managing CRS/ICANS |
| Tocilizumab | IL-6 receptor blockade | First-line treatment for CRS; must be available | Keep available at treatment center; use per CRS management protocol |
| Live vaccines (MMR, varicella, oral polio) | Infection risk | Risk of vaccine-strain infection due to immunosuppression | Avoid for 6 weeks before and during treatment; wait for immune recovery |
| Cytotoxic chemotherapy | T-cell depletion | May deplete infused CAR T-cells if given too soon after treatment | Coordinate timing with oncology team |
| Anti-CD20 antibodies (rituximab) | B-cell depletion | May affect target antigen expression on cancer cells | Discuss timing with oncology team |
| Immunomodulators (lenalidomide) | Immune modulation | Potential for unpredictable immune effects | Review with healthcare team before treatment |
Tocilizumab (an IL-6 receptor antagonist) must be available at the treatment center before Breyanzi infusion and during the recovery period. It is the primary treatment for cytokine release syndrome (CRS). In exceptional cases where tocilizumab is unavailable due to supply shortages, the treatment center must have appropriate alternative measures in place.
How Is Breyanzi Administered?
Breyanzi is given as a one-time intravenous infusion of two components (CD8+ cells followed by CD4+ cells), with each infusion typically taking less than 15 minutes. The entire treatment process, from cell collection to infusion, takes several weeks.
Breyanzi is not a conventional medication that you take at home. It is a complex, personalized cell therapy that requires specialized manufacturing and administration at certified treatment centers. The treatment process involves several distinct phases, each of which is carefully coordinated by your healthcare team.
The Treatment Process
Step 1: Cell Collection (Leukapheresis)
Your healthcare provider will collect your white blood cells through a process called leukapheresis. A catheter is placed in your vein, and blood is drawn through a machine that separates the white blood cells (T-cells) from the rest of your blood, which is then returned to your body. This procedure typically takes 3 to 6 hours and may need to be repeated.
Step 2: Manufacturing (3–4 weeks)
Your collected T-cells are sent to a specialized laboratory where they are genetically modified to express the chimeric antigen receptor (CAR) targeting CD19. The cells are then expanded (multiplied) to achieve the required dose. This manufacturing process typically takes 3 to 4 weeks.
Step 3: Lymphodepleting Chemotherapy
A few days before receiving Breyanzi, you will receive a short course of chemotherapy. This is designed to reduce your existing white blood cells and create space for the CAR T-cells to expand effectively once infused. Your oncology team will determine the specific chemotherapy regimen.
Step 4: Pre-Medication
Shortly before the infusion, you will receive paracetamol (acetaminophen) and an antihistamine to reduce the risk of infusion reactions and fever.
Step 5: Breyanzi Infusion
Breyanzi is administered as two sequential intravenous infusions. First, the CD8-positive cells are infused, immediately followed by the CD4-positive cells. Each infusion typically takes less than 15 minutes. Before infusion, the healthcare team verifies that the patient information on the product label matches your identity.
Dosing Details
| Parameter | Details |
|---|---|
| Adult dose | CD8+ cells: up to 70 × 106 CAR+ viable cells; CD4+ cells: up to 70 × 106 CAR+ viable cells |
| Administration route | Intravenous infusion at approximately 0.5 mL/min |
| Infusion time | Usually less than 15 minutes per cell type |
| Number of infusions | One-time treatment (2 sequential infusions: CD8+ then CD4+) |
| Children and adolescents | Not indicated for patients under 18 years of age |
| Monitoring period | Minimum 2 weeks near treatment center; follow-up visits 2–3 times in first week |
Patient Card
After receiving Breyanzi, your healthcare provider will give you a patient card. This card contains important information about your treatment and should be carried with you at all times. Always show this card to any healthcare provider you visit, whether at a hospital, clinic, or emergency department, as it contains critical information about your treatment that may influence your medical care.
Missed Appointment
If you miss a scheduled appointment during your Breyanzi treatment process, contact your healthcare provider or treatment center as soon as possible to reschedule. Timely follow-up is essential for monitoring your response to treatment and managing any side effects.
After receiving Breyanzi, you should not donate blood, organs, tissues, or cells for transplantation. The genetically modified cells in your body could potentially be transferred to a recipient.
Long-Term Follow-Up
You will be asked to participate in a patient registry for at least 15 years after treatment. This long-term follow-up helps researchers understand the lasting effects of Breyanzi, both beneficial and adverse. The registry provides valuable data on the long-term safety and effectiveness of CAR T-cell therapy and contributes to improving treatment for future patients.
What Are the Side Effects of Breyanzi?
The most serious side effects of Breyanzi include cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and severe infections. Most patients experience some side effects, but they can typically be managed at certified treatment centers.
Like all medicines, Breyanzi can cause side effects, although not everybody experiences them. Because Breyanzi activates the immune system in a powerful way, some of these side effects can be serious and require immediate medical attention. Your healthcare team at the certified treatment center is specifically trained to recognize and manage these effects.
Serious Side Effects — Seek Immediate Medical Attention
- Cytokine Release Syndrome (CRS): Fever, chills, shaking, fatigue, rapid or irregular heartbeat, dizziness, shortness of breath. CRS typically occurs within 1–2 weeks after infusion.
- Neurotoxicity (ICANS): Confusion, reduced alertness, difficulty speaking or slurred speech, tremor, agitation, dizziness, headache.
- Infections: Feeling warm, fever, chills, or shaking, caused by low white blood cell counts or low immunoglobulin levels.
- Progressive Multifocal Leukoencephalopathy (PML): Blurred vision, vision loss, double vision, difficulty speaking, weakness, gait changes, personality changes, confusion. These may appear months after treatment.
- Severe anemia: Extreme tiredness, weakness, shortness of breath.
- Low platelet counts: Bleeding or bruising more easily than normal.
Side Effects by Frequency
Very Common
- Difficulty sleeping (insomnia)
- Low blood pressure (hypotension) with dizziness, fainting, or visual changes
- Cough
- Nausea or vomiting
- Diarrhea or constipation
- Abdominal pain
- Swollen ankles, arms, legs, and face (edema)
- Skin rash
Common
- Balance problems or difficulty walking
- High blood pressure with severe headache, sweating, or insomnia
- Visual changes
- Taste changes
- Numbness and tingling in feet or hands (peripheral neuropathy)
- Blood clots or clotting disorders
- Gastrointestinal bleeding
- Decreased urine output
- Infusion reactions (dizziness, fever, shortness of breath)
- Low phosphate levels in blood
- Low oxygen levels in blood (hypoxia)
Uncommon
- Secondary T-cell malignancy (new cancer originating from T-cells)
- Tumor lysis syndrome (rapid breakdown of cancer cells causing toxic byproducts; dark urine, nausea, flank pain)
- Severe inflammatory condition (hemophagocytic lymphohistiocytosis/macrophage activation syndrome)
- Heart failure causing shortness of breath and swollen ankles
- Fluid around the lungs (pleural effusion)
- Stroke or transient ischemic attack (TIA)
- Seizures or convulsions
- Facial muscle weakness, vocal cord weakness, or body weakness
- Brain swelling (cerebral edema)
Understanding Cytokine Release Syndrome (CRS)
CRS is one of the most significant side effects of CAR T-cell therapy. It occurs when the modified T-cells become activated and release large amounts of cytokines (inflammatory signaling molecules) into the bloodstream. This immune activation is actually a sign that the treatment is working, but it can cause a range of symptoms from mild fever to life-threatening organ dysfunction.
CRS typically develops within the first 1 to 14 days after Breyanzi infusion. Symptoms can range from mild (low-grade fever, fatigue) to severe (high fever, hypotension, respiratory distress, multi-organ failure). The grading system used by healthcare teams ranges from Grade 1 (mild) to Grade 4 (life-threatening). Most cases of CRS with Breyanzi are Grade 1 or 2 and can be managed with supportive care and tocilizumab.
Your treatment center has protocols in place for early detection and management of CRS. The key to good outcomes is early recognition and prompt treatment. This is why patients must remain near the treatment center for at least 2 weeks after infusion.
Understanding ICANS (Neurotoxicity)
Immune effector cell-associated neurotoxicity syndrome (ICANS) is another significant concern with CAR T-cell therapy. It can occur alongside or independently of CRS and involves neurological symptoms caused by the immune response. Symptoms include confusion, difficulty speaking, tremors, altered consciousness, seizures, and in rare cases, cerebral edema (brain swelling).
ICANS can range from mild cognitive difficulties to severe, life-threatening neurological events. Healthcare teams use standardized assessment tools to monitor patients for early signs of ICANS. Treatment may include corticosteroids and supportive care. Most cases resolve with appropriate management, though some patients may experience prolonged effects.
How Should Breyanzi Be Stored?
Breyanzi must be stored frozen in the vapor phase of liquid nitrogen at or below −130°C (−202°F). This product is handled exclusively by healthcare professionals at certified treatment centers and is never stored by patients.
Breyanzi has extremely strict storage requirements due to its nature as a living cell product. The frozen dispersion must be maintained at ultra-low temperatures in the vapor phase of liquid nitrogen (at or below −130°C) to preserve cell viability and therapeutic potency. These storage conditions can only be achieved with specialized cryogenic equipment available at certified treatment facilities.
Once Breyanzi vials are removed from frozen storage and thawing begins, the product must be administered to the patient within 2 hours. This narrow time window is critical, as the genetically modified T-cells begin to lose viability once thawed. Healthcare teams carefully coordinate the timing of thawing with the patient's readiness for infusion to ensure no product is wasted.
Patients should never attempt to store, transport, or handle Breyanzi themselves. The entire cold chain management, from manufacturing facility to the patient's bedside, is maintained by trained healthcare professionals and specialized logistics companies. Each shipment is tracked and temperature-monitored to ensure product integrity.
As with all medicines, Breyanzi should not be used after the expiration date stated on the outer cartons and vial label. Keep all medicines out of sight and reach of children.
What Does Breyanzi Contain?
Breyanzi contains the patient's own genetically modified T-cells (lisocabtagene maraleucel) as the active substance, along with a cryopreservation solution and other excipients. Each vial contains 4.6 mL of cell dispersion.
Breyanzi is a unique medicine in that its active ingredient consists of living human cells that have been genetically modified. Each dose is individually manufactured from the patient's own blood cells, making it a truly personalized medicine. The product contains two types of cells: CD8-positive CAR T-cells and CD4-positive CAR T-cells, provided in separate vials.
Active Substance
Each 4.6 mL vial contains a dispersion of CAR-positive viable T-cells (either CD8-positive or CD4-positive cells) at a concentration of 1.1 × 106 to 70 × 106 CAR-positive viable T-cells per milliliter for each cell type. Depending on the concentration of the frozen product, up to 4 vials of each cell type (CD8+ and CD4+) may be needed for a complete dose.
Other Ingredients (Excipients)
- Cryostor CS10: A cryopreservation solution containing dimethyl sulfoxide (DMSO), which can cause hypersensitivity reactions
- Sodium chloride
- Sodium gluconate
- Sodium acetate trihydrate
- Potassium chloride
- Magnesium chloride
- Human albumin
- N-acetyl-DL-tryptophan
- Caprylic acid
- Water for injections
Sodium and Potassium Content
Each vial of Breyanzi contains up to 12.5 mg of sodium, equivalent to 0.6% of the WHO recommended maximum daily intake for adults. Since up to 8 vials may be administered per dose, the total sodium content can be up to 100 mg (5% of the recommended maximum daily intake).
The product also contains up to 0.2 mmol (6.5 mg) of potassium per dose. Your healthcare provider will take this into account if you have impaired kidney function or are on a potassium-restricted diet.
Appearance
Breyanzi is a slightly opalescent to opalescent, colorless to yellow or brownish-yellow cell dispersion. It is supplied in vials, each containing 4.6 mL of cell dispersion of either CD8-positive or CD4-positive cells.
This medicine contains genetically modified human blood cells. Healthcare professionals handling Breyanzi must use appropriate protective equipment (gloves, protective clothing, eye protection) to prevent potential transmission of infectious diseases. Any unused product and all materials that have been in contact with Breyanzi must be handled and disposed of as potentially infectious waste.
Frequently Asked Questions About Breyanzi
Medical References and Sources
This article is based on current medical research and international regulatory documents. All claims are supported by scientific evidence from peer-reviewed sources and official product information.
- European Medicines Agency (2022). "Breyanzi (lisocabtagene maraleucel) — Summary of Product Characteristics." EMA Product Information Official European product information including approved indications, dosing, and safety data. Evidence level: Regulatory approval.
- U.S. Food and Drug Administration (2021). "BREYANZI (lisocabtagene maraleucel) — Prescribing Information." FDA Prescribing Information U.S. regulatory approval documentation with full prescribing information. Evidence level: Regulatory approval.
- Abramson JS, Palomba ML, Gordon LI, et al. (2020). "Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study." The Lancet, 396(10254), 839–852. DOI: 10.1016/S0140-6736(20)31366-0 Pivotal TRANSCEND NHL 001 trial demonstrating efficacy and safety of liso-cel in r/r LBCL. Evidence level: 1B (individual RCT).
- Kamdar M, Solomon SR, Arnason J, et al. (2022). "Lisocabtagene maraleucel versus standard of care with salvage chemotherapy followed by autologous stem cell transplantation as second-line treatment in patients with relapsed or refractory large B-cell lymphoma (TRANSFORM): results from an interim analysis of an open-label, randomised, phase 3 trial." The Lancet, 399(10343), 2294–2308. DOI: 10.1016/S0140-6736(22)00662-6 TRANSFORM trial comparing liso-cel to standard of care as second-line therapy. Evidence level: 1B (phase 3 RCT).
- National Comprehensive Cancer Network (2025). "NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas, Version 1.2025." NCCN Guidelines Comprehensive clinical practice guidelines for B-cell lymphoma management including CAR T-cell therapy. Evidence level: 1A (systematic review/guideline).
- Lee DW, Santomasso BD, Locke FL, et al. (2019). "ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells." Biology of Blood and Marrow Transplantation, 25(4), 625–638. DOI: 10.1016/j.bbmt.2018.12.758 ASTCT consensus on CRS and ICANS grading systems used in clinical practice. Evidence level: Expert consensus.
- World Health Organization (2023). "WHO Model List of Essential Medicines — 23rd Edition." WHO Essential Medicines Global reference for essential medicines and access considerations. Evidence level: International guideline.
- Hayden PJ, Roddie C, Bader P, et al. (2022). "Management of adults and children receiving CAR T-cell therapy: 2021 best practice recommendations of the European Society for Blood and Marrow Transplantation (EBMT) and the Joint Accreditation Committee of ISCT and EBMT (JACIE) and the European Haematology Association (EHA)." Annals of Oncology, 33(3), 259–275. DOI: 10.1016/j.annonc.2021.12.003 European best practice recommendations for CAR T-cell therapy management. Evidence level: 1A (expert consensus/guideline).
Evidence grading: This article uses the GRADE framework (Grading of Recommendations Assessment, Development and Evaluation) for evidence-based medicine. Evidence level 1A represents the highest quality of evidence, based on systematic reviews of randomized controlled trials.
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