Kymriah (Tisagenlecleucel)
CAR-T Cell Therapy for B-Cell Acute Lymphoblastic Leukaemia, DLBCL, and Follicular Lymphoma
Quick Facts About Kymriah
Key Takeaways About Kymriah
- Personalised immunotherapy: Kymriah is manufactured from the patient’s own T cells, genetically modified to target CD19-positive cancer cells – making each dose unique to the individual patient
- One-time infusion: Kymriah is given as a single intravenous infusion, and the engineered T cells can persist in the body for months to years, providing ongoing cancer surveillance
- Cytokine release syndrome (CRS) risk: CRS is a very common and potentially life-threatening side effect that occurs when CAR-T cells rapidly activate – tocilizumab must be available on-site before infusion
- Monitoring required: Patients must remain within 2 hours of the treatment centre for at least 4 weeks after infusion and undergo regular blood tests
- Three approved indications: Kymriah treats relapsed/refractory B-cell ALL (patients up to 25 years), DLBCL (adults), and follicular lymphoma (adults) when prior therapies have failed
What Is Kymriah and What Is It Used For?
Kymriah (tisagenlecleucel) is a chimeric antigen receptor T-cell (CAR-T) therapy – a revolutionary form of personalised cancer immunotherapy. It is made from the patient’s own white blood cells (T cells), which are genetically modified in a laboratory to recognise and destroy cancer cells that carry a protein called CD19 on their surface.
CAR-T cell therapy represents a paradigm shift in cancer treatment. Unlike conventional chemotherapy or radiation, which directly attack rapidly dividing cells, Kymriah harnesses the power of the patient’s own immune system. T cells – a type of white blood cell central to immune defence – are collected from the patient’s blood, transported to a specialised manufacturing facility, and genetically reprogrammed using a lentiviral vector. This vector introduces a gene that encodes a chimeric antigen receptor (CAR), a synthetic protein designed to recognise and bind to CD19, a surface marker found on most B-cell cancers.
Once the engineered CAR-T cells are infused back into the patient’s bloodstream, they actively seek out and bind to CD19-positive cells. Upon binding, the CAR-T cells become activated, multiply rapidly, and directly kill the target cancer cells through a process called cytotoxicity. Importantly, the CAR-T cells can persist in the body long after the initial infusion, continuing to provide immunosurveillance against any remaining or recurring CD19-positive cancer cells.
Approved Indications
Kymriah is approved for the treatment of three distinct types of B-cell cancers:
- B-cell acute lymphoblastic leukaemia (B-ALL): A cancer of the white blood cells that primarily affects children and young adults. Kymriah may be used in patients up to and including 25 years of age whose B-ALL has not responded to prior treatment (refractory), has relapsed two or more times, or has relapsed after a stem cell transplant. The pivotal ELIANA trial demonstrated a complete remission rate of approximately 82% in paediatric and young adult patients with relapsed or refractory B-ALL.
- Diffuse large B-cell lymphoma (DLBCL): The most common type of non-Hodgkin lymphoma, affecting B cells in the lymph nodes. Kymriah is indicated for adult patients (18 years and older) whose DLBCL has relapsed or not responded to two or more lines of systemic therapy. The JULIET trial showed an overall response rate of approximately 52%, with 40% of patients achieving a complete response.
- Follicular lymphoma (FL): A slow-growing form of non-Hodgkin lymphoma arising from B-cell lymphocytes in the lymph nodes. Kymriah is approved for adult patients (18 years and older) whose FL has relapsed or not responded to two or more prior lines of therapy. The ELARA trial demonstrated an overall response rate of approximately 86%, with a complete response rate of 68%.
Kymriah was the first CAR-T cell therapy to receive FDA approval in 2017 and EMA authorisation in 2018, marking a historic milestone in cancer treatment. It is manufactured by Novartis and remains one of only a handful of approved gene therapies worldwide. The name “tisagenlecleucel” reflects its nature as an autologous (self-derived), genetically modified cellular product.
What Should You Know Before Receiving Kymriah?
Before receiving Kymriah, your medical team will conduct extensive health assessments including lung, heart, and blood pressure checks, screen for infections, and evaluate whether your cancer has worsened. Kymriah is contraindicated if you are allergic to any of its ingredients or cannot receive lymphodepleting chemotherapy.
CAR-T cell therapy is a highly specialised treatment that requires thorough preparation and careful patient selection. Your treating physician will assess multiple aspects of your health to determine whether Kymriah is appropriate and safe for you. This evaluation typically begins weeks before the actual infusion and includes a comprehensive medical history, physical examination, blood tests, imaging studies, and assessment of organ function.
Contraindications
You should not receive Kymriah if:
- You are allergic to tisagenlecleucel or any of the other ingredients in the product, including dimethyl sulfoxide (DMSO), dextran 40, human albumin, sodium chloride, or sodium gluconate. Consult your doctor if you believe you may be allergic.
- You cannot receive lymphodepleting chemotherapy – a short course of chemotherapy given before the infusion to reduce the number of white blood cells in your body and create space for the CAR-T cells to expand.
Warnings and Precautions
Before receiving Kymriah, you must inform your doctor if any of the following apply to you:
- You have had a stem cell transplant within the past 4 months. Your doctor will check for signs or symptoms of graft-versus-host disease (GvHD) – a condition where transplanted cells attack your body, causing skin rash, nausea, vomiting, diarrhoea, and bloody stool.
- You have heart, lung, or blood pressure problems (low or high), as these may increase the risk of complications during and after treatment.
- Your cancer symptoms are worsening. In leukaemia, this may include fever, feeling weak, bleeding gums, or bruising. In lymphoma, it may include unexplained fever, weakness, night sweats, or sudden weight loss.
- You have an active infection. The infection will be treated before you can receive Kymriah.
- You have had hepatitis B, hepatitis C, or HIV infection. These conditions may complicate treatment and require additional monitoring.
- You are pregnant, think you may be pregnant, or are planning to become pregnant. The effects of Kymriah on pregnant or breastfeeding women are not known.
- You have been vaccinated within the past 6 weeks or plan to be vaccinated in the near future. Live vaccines must be avoided before, during, and after treatment while the immune system is recovering.
Patients treated with Kymriah and similar CAR-T cell products have been reported to develop new cancers, including T-cell malignancies. Tell your doctor immediately if you notice any new swelling in your lymph nodes, skin changes such as new rashes or lumps, or any other unusual symptoms. You will be asked to participate in a patient registry for a minimum of 15 years for long-term monitoring of safety outcomes.
Pre-Treatment Tests and Examinations
Before receiving Kymriah, your doctor will perform the following assessments:
- Lung, heart, and blood pressure evaluation to ensure you can safely tolerate the treatment and any potential complications such as CRS.
- Infection screening – any active infection must be fully resolved before Kymriah can be administered.
- Cancer status assessment to determine whether your leukaemia or lymphoma has worsened since the decision to treat.
- Graft-versus-host disease screening if you have previously received a stem cell transplant.
- Uric acid and tumour burden testing to assess the risk of tumour lysis syndrome (TLS), a potentially dangerous condition caused by rapid breakdown of tumour cells. You may receive medication to reduce this risk.
- Hepatitis B, hepatitis C, and HIV testing for infection control and to guide treatment planning.
Pregnancy and Breastfeeding
The effects of Kymriah on pregnant or breastfeeding women are not known, and the treatment could potentially harm an unborn child or a newborn infant. If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before receiving this treatment. A pregnancy test will be performed before treatment begins, and Kymriah will only be administered if the result confirms you are not pregnant.
If you become pregnant or suspect pregnancy after receiving Kymriah, contact your doctor immediately. Discuss contraception with your medical team, as appropriate precautions should be taken both during and after treatment.
Driving and Operating Machinery
Some patients may experience confusion, altered or decreased consciousness, seizures, or difficulty with balance after receiving Kymriah. You should not drive any vehicle, operate machinery, or participate in any activity that requires concentration or alertness for at least 8 weeks after the infusion. These neurological effects are related to a condition called immune effector cell-associated neurotoxicity syndrome (ICANS) and typically occur within the first 8 weeks but can also develop later.
Blood and Organ Donation
After receiving Kymriah, you must not donate blood, organs, tissues, sperm, eggs, or cells. This is because Kymriah contains genetically modified cells that could be transferred to a recipient through donation. This restriction applies for your lifetime after treatment.
How Does Kymriah Interact with Other Drugs?
Tell your doctor about all medicines you take, including over-the-counter products. Immunosuppressive medications such as corticosteroids can affect how well Kymriah works. Live vaccines must be avoided before, during, and after treatment. No traditional drug-drug interactions apply since Kymriah is a cellular product, not a chemical compound.
Because Kymriah is a living cellular therapy rather than a conventional pharmaceutical drug, its interaction profile is fundamentally different from that of small-molecule medications. Kymriah is not metabolised by liver enzymes and does not interact with cytochrome P450 pathways. However, several important therapeutic considerations exist regarding co-administered medications that may affect the function of the infused CAR-T cells or the patient’s overall immune status.
Immunosuppressive Medications
Before receiving Kymriah, inform your doctor if you are taking any medications that suppress the immune system, such as corticosteroids (e.g. prednisolone, dexamethasone, methylprednisolone), calcineurin inhibitors (e.g. tacrolimus, cyclosporine), or other immunosuppressants. These medications may impair the ability of CAR-T cells to expand and function effectively after infusion.
Paradoxically, corticosteroids are also used after infusion to manage certain side effects such as CRS and ICANS when other treatments (e.g. tocilizumab) are insufficient. In this context, their use is carefully balanced against the potential impact on CAR-T cell efficacy. Your medical team will make these decisions based on the severity of your symptoms.
Vaccination Restrictions
Live vaccines must be strictly avoided at the following times:
- During the 6 weeks before lymphodepleting chemotherapy
- During Kymriah treatment
- After treatment until your immune system has fully recovered, which may take several months or longer
Inactivated vaccines may be administered, but their effectiveness may be reduced in the context of immunosuppression following CAR-T cell therapy. Consult your doctor about the appropriate timing of any vaccinations.
| Agent | Category | Interaction | Recommendation |
|---|---|---|---|
| Corticosteroids | Immunosuppressant | May impair CAR-T cell expansion and efficacy if given before/during infusion | Discontinue before Kymriah; use post-infusion only for CRS/ICANS management |
| Live vaccines | Immunisation | Risk of vaccine-related infection due to immunocompromised state | Avoid for 6 weeks before chemo and until immune recovery after Kymriah |
| Tocilizumab | IL-6 receptor antagonist | First-line treatment for CRS; must be available on-site before Kymriah infusion | At least 1 dose per patient must be available; additional doses within 8 hours |
| Lymphodepleting chemotherapy | Pre-conditioning regimen | Required to create immunological space for CAR-T cell expansion | Administered days before Kymriah infusion as per treatment protocol |
| Paracetamol / Antihistamines | Pre-medication | Given 30–60 minutes before infusion to prevent infusion reactions and fever | Standard pre-medication protocol; follow institutional guidelines |
What Is the Treatment Process for Kymriah?
The Kymriah treatment process involves several stages over several weeks: T-cell collection via leukapheresis, manufacturing of the CAR-T cells (3–4 weeks), lymphodepleting chemotherapy, and finally the Kymriah infusion itself, which typically takes less than 1 hour. Kymriah is a one-time treatment.
Unlike conventional chemotherapy, which uses off-the-shelf drugs, Kymriah requires a multi-step, personalised manufacturing process. Understanding each stage helps patients and caregivers prepare for what to expect throughout the treatment journey.
Step 1: T-Cell Collection (Leukapheresis)
The first step involves collecting T cells from your blood through a procedure called leukapheresis. A catheter is placed in a vein, and your blood is drawn through a machine that separates out white blood cells. The remaining blood components are returned to your body. This procedure typically takes 3 to 6 hours and may need to be repeated. The collected white blood cells are then frozen and shipped to a Novartis manufacturing facility.
Step 2: CAR-T Cell Manufacturing
At the manufacturing facility, your T cells are genetically modified using a lentiviral vector to express the chimeric antigen receptor (CAR) targeting CD19. The modified cells are then expanded to therapeutic numbers, quality-tested, frozen, and shipped back to your treatment centre. This manufacturing process typically takes 3 to 4 weeks, although the time can vary.
Step 3: Bridging Therapy (If Needed)
During the manufacturing period, your cancer may continue to progress. If necessary, your doctor may administer bridging therapy – additional cancer treatment to stabilise your disease while waiting for Kymriah. This bridging therapy may include chemotherapy, targeted therapy, or other agents depending on your specific cancer type and disease status. Your doctor will inform you about the potential side effects of any bridging therapy used.
Step 4: Lymphodepleting Chemotherapy
A few days before receiving Kymriah, you will receive a short course of lymphodepleting chemotherapy. This regimen reduces the number of your existing white blood cells, creating immunological space for the CAR-T cells to expand and persist once infused. Common regimens include fludarabine and cyclophosphamide, or bendamustine.
Step 5: Kymriah Infusion
On the day of infusion, you will first receive pre-medications (paracetamol and an antihistamine such as diphenhydramine) 30–60 minutes before Kymriah to reduce the risk of infusion reactions and fever. Your identity will be verified against the information on the infusion bag to ensure you receive your own personalised product.
Kymriah is administered as an intravenous infusion through a tube into a vein, typically taking less than 1 hour. During the infusion, your medical team will closely monitor you for any signs of allergic reactions, breathing difficulties, or dizziness. If the volume is 20 ml or less, it may be given as an intravenous push rather than a standard infusion.
Step 6: Post-Infusion Monitoring
After receiving Kymriah, you must remain within 2 hours’ travel distance of the treatment centre for at least 4 weeks. During the first week, your doctor will typically ask you to visit the hospital 2 to 3 times for monitoring. Key monitoring activities include:
- Temperature monitoring: Measure your temperature twice daily for 3–4 weeks after infusion. Contact your doctor immediately if your temperature is elevated.
- Regular blood tests: Your blood counts and other laboratory values will be checked frequently, as the number of blood cells and other blood components may decrease significantly.
- Neurological assessment: You will be monitored for signs of ICANS, including confusion, difficulty speaking, altered consciousness, or seizures.
- Infection surveillance: Your weakened immune system places you at increased risk of infections, which may be serious or life-threatening.
Kymriah is a one-time treatment. Unlike chemotherapy, which typically requires multiple cycles over months, the CAR-T cells are designed to persist and multiply within your body, providing ongoing cancer surveillance. However, the weeks surrounding the infusion require intensive medical monitoring and support.
What Are the Side Effects of Kymriah?
The most significant side effects of Kymriah include cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), both of which can be life-threatening. Other very common side effects include infections, reduced blood cell counts, and metabolic disturbances. Close monitoring at a specialised centre is essential.
Like all medicines, Kymriah can cause side effects, although not everybody will experience them. Because Kymriah is a powerful immunotherapy that activates the immune system intensely, its side effect profile is distinct from conventional cancer treatments. The most serious adverse events typically occur within the first 8 weeks after infusion but can develop later. Understanding these risks is essential for patients and caregivers to recognise warning signs early and seek prompt medical attention.
High fever with chills, difficulty breathing, rapid heartbeat, low blood pressure, confusion, seizures, difficulty speaking, altered consciousness, or severe swelling. These may be signs of CRS or ICANS, which require emergency treatment.
Very Common
- Cytokine release syndrome (CRS): High fever, chills, breathing difficulties, nausea, vomiting, diarrhoea, loss of appetite, fatigue, muscle pain, joint pain, swelling, low blood pressure, rapid heartbeat, headache, heart/lung/kidney/liver dysfunction, dizziness – typically within first 14 days
- ICANS: Altered thinking, decreased consciousness, confusion, agitation, seizures, difficulty speaking or understanding, loss of balance – typically within first 8 weeks
- Infections: Feeling warm, fever, chills, sore throat, or mouth sores; some infections may be life-threatening
- Anaemia: Pale skin, weakness, shortness of breath due to low red blood cell count
- Thrombocytopenia: Heavy or prolonged bleeding, easy bruising due to low platelet count
- Febrile neutropenia: Fever with a dangerously low white blood cell count
- Leukopenia: Increased risk of infection due to abnormally low white blood cell count
- Hypogammaglobulinaemia: Frequent and persistent infections due to reduced antibody levels
- Electrolyte imbalances: Weakness, abnormal heart rhythm due to low phosphorus, potassium, or other salts
- Elevated liver enzymes or creatinine indicating liver or kidney stress
- Elevated blood pressure, shortness of breath, increased respiratory rate, cough
- Abdominal pain, constipation, bone and back pain, skin rash
- Peripheral oedema: Swelling of ankles, arms, legs, and face
Common
- Tumour lysis syndrome: Rapid breakdown of tumour cells releasing contents into the blood, potentially affecting kidneys, heart, and nervous system
- Haemophagocytic lymphohistiocytosis (HLH): Fever, malaise, enlarged liver, jaundice, low blood counts due to severe immune activation
- Infusion reactions: Dizziness, fainting, flushing, rash, itching, fever, shortness of breath, vomiting, stomach pain, diarrhoea
- Graft-versus-host disease: Rash, nausea, vomiting, diarrhoea including bloody stool (in patients with prior transplant)
- Seizures, muscle spasms, tremor, involuntary movements
- Tingling or numbness, vision impairment, nerve pain
- Hyperglycaemia: Thirst, low urine output, dark urine, dry skin, irritability
- Anxiety, insomnia, severe confusion, weight loss
- Heart failure, rapid or irregular heartbeat, cardiac arrest
- Blood clots, fluid leakage from blood vessels, abdominal fluid accumulation
- Dry mouth, oral pain, oral bleeding, jaundice, itching, excessive sweating
- Multiple organ failure, fluid in the lungs, nasal congestion
- Coagulation disorders: Bleeding problems, prolonged clotting times, decreased fibrinogen
Uncommon
- Abnormal blood tests (elevated magnesium)
- Weakness or paralysis of limbs or face, speech difficulties (possible stroke symptoms from reduced blood supply)
- Warm skin or sudden flushing
- Mucous-producing or blood-tinged cough with fever, shortness of breath
- Difficulty controlling movements
Rare
- Secondary T-cell malignancy: A new type of cancer originating from T cells (the modified cells). Although rare, this is a serious concern that necessitates long-term monitoring.
Additionally, some patients may experience effects of unknown frequency, including breathing difficulties or dizziness from allergic reactions, and neurological symptoms such as weakness, numbness, vision loss, irrational thoughts, headache, memory impairment, or unusual behaviour.
Certain HIV test results may be affected after Kymriah treatment. Ask your doctor about this if relevant to your situation.
How Should Kymriah Be Stored?
Kymriah must be stored and transported at extremely low temperatures (≤ −120°C) and should not be thawed until ready for use. Storage and handling are managed entirely by the treatment centre – patients do not store this product at home.
Unlike conventional oral medications that patients store at home, Kymriah is a specialised biological product that remains under the control of the treatment centre throughout its lifecycle. The storage requirements are among the most stringent of any approved medicine:
- Storage temperature: ≤ −120°C (typically in vapour-phase liquid nitrogen storage). The product must not be thawed until it is ready for use.
- Transport: Kymriah must be transported within the facility in closed, unbreakable, leak-proof containers.
- Do not use if the infusion bag appears damaged or is leaking.
- Once thawed: Kymriah must reach room temperature (20–25°C) and be infused within 30 minutes to preserve maximum cell viability.
- Thawing procedure: The infusion bag is thawed at 37°C using a water bath or dry method, placed inside a sterile secondary bag to prevent contamination.
- Expiry date: Check the label on the infusion bag for the expiry date (EXP). Do not use after this date.
Keep all medicines out of the sight and reach of children. Healthcare professionals handling Kymriah must use appropriate protective equipment (gloves and eye protection) to prevent potential transmission of infectious diseases, as the product contains human-derived cells.
What Does Kymriah Contain?
Kymriah contains tisagenlecleucel – autologous T cells genetically modified to express an anti-CD19 chimeric antigen receptor. The other ingredients include glucose, sodium chloride, human albumin, dextran 40, DMSO, and several buffer salts.
Active Ingredient
The active substance is tisagenlecleucel. Each infusion bag contains a batch-dependent concentration of autologous (patient-derived) T cells genetically modified to express a chimeric antigen receptor (CAR) targeting CD19. One or more infusion bags contain a total of 1.2×106 to 6×108 CAR-positive viable T cells.
Other Ingredients
The other ingredients (excipients) are:
- Glucose
- Sodium chloride
- Human albumin solution
- Dextran 40 for injection
- Dimethyl sulfoxide (DMSO)
- Sodium gluconate
- Sodium acetate
- Potassium chloride
- Magnesium chloride
- Sodium N-acetyltryptophan
- Sodium caprylate
- Aluminium
- Water for injections
This medicine contains 24.3 to 121.5 mg sodium per dose (equivalent to 1–6% of the WHO-recommended maximum daily intake for adults). It also contains dextran 40 and DMSO, which are used to preserve the frozen cells and may cause breathing difficulty or dizziness (possible symptoms of allergic or hypersensitivity reactions). Patients are closely monitored during the infusion period. The potassium content is less than 1 mmol (39 mg) per dose, making it essentially potassium-free.
Appearance and Packaging
Kymriah is a cell dispersion for infusion. It is supplied in one or more infusion bags, each containing 10 to 50 ml of a cloudy to clear, colourless to light yellow cell dispersion. This medicine contains cells of human origin.
The marketing authorisation holder is Novartis Europharm Limited (Dublin, Ireland), and the product is manufactured by Novartis Pharma GmbH (Nuremberg, Germany).
Frequently Asked Questions About Kymriah
Kymriah (tisagenlecleucel) is a CAR-T cell therapy – a form of personalised immunotherapy. Your own white blood cells (T cells) are collected, sent to a laboratory, and genetically modified to express a chimeric antigen receptor (CAR) that recognises a protein called CD19 found on the surface of certain cancer cells. Once infused back into your body, these engineered T cells seek out and destroy CD19-positive cancer cells. Kymriah was the first CAR-T cell therapy approved by the FDA (2017) and EMA (2018).
Kymriah is approved for three indications: (1) B-cell acute lymphoblastic leukaemia (B-ALL) in patients up to 25 years old with relapsed or refractory disease; (2) diffuse large B-cell lymphoma (DLBCL) in adults who have relapsed or not responded to two or more prior therapies; and (3) follicular lymphoma (FL) in adults who have relapsed or not responded to two or more prior therapies. All three conditions involve cancers of B cells that express the CD19 protein.
Cytokine release syndrome (CRS) is a serious immune reaction that occurs when the infused CAR-T cells become activated and release large amounts of inflammatory proteins (cytokines) into the blood. Symptoms include high fever, chills, breathing difficulties, low blood pressure, rapid heartbeat, nausea, and organ dysfunction. CRS is very common with Kymriah and typically occurs within the first 14 days after infusion. It is managed primarily with tocilizumab (an IL-6 receptor antagonist), which must be available on-site before infusion. Supportive care and, if necessary, corticosteroids are also used. Most cases of CRS are reversible with appropriate treatment.
The total process spans several weeks. T-cell collection (leukapheresis) takes 3–6 hours. Manufacturing at the Novartis facility typically takes 3–4 weeks. Lymphodepleting chemotherapy is given over several days before the infusion. The infusion itself usually takes less than 1 hour. After infusion, patients must remain within 2 hours of the treatment centre for at least 4 weeks for close monitoring. Full immune recovery may take several months.
Kymriah is designed as a one-time infusion. The genetically modified CAR-T cells can persist in the body for months to years, continuing to provide surveillance against CD19-positive cancer cells. Re-treatment is not standard practice, and the current regulatory approvals are based on single-infusion clinical trial data. If your cancer returns after Kymriah treatment, your doctor will discuss alternative treatment options with you.
All information is based on international regulatory documents and peer-reviewed research: the European Medicines Agency (EMA) European Public Assessment Report (EPAR) for Kymriah, FDA prescribing information, NCCN Clinical Practice Guidelines for ALL and B-Cell Lymphomas, and landmark clinical trial publications including the ELIANA trial (New England Journal of Medicine, 2018), JULIET trial (New England Journal of Medicine, 2019), and ELARA trial (The Lancet Oncology, 2022). Evidence level 1A.
References
- European Medicines Agency (EMA). Kymriah (tisagenlecleucel) – European Public Assessment Report (EPAR). EMA/680501/2018. Available at: ema.europa.eu/en/medicines/human/EPAR/kymriah.
- Maude SL, Laetsch TW, Buechner J, et al. Tisagenlecleucel in Children and Young Adults with B-Cell Lymphoblastic Leukemia. N Engl J Med. 2018;378(5):439–448. doi:10.1056/NEJMoa1709866.
- Schuster SJ, Bishop MR, Tam CS, et al. Tisagenlecleucel in Adult Relapsed or Refractory Diffuse Large B-Cell Lymphoma. N Engl J Med. 2019;380(1):45–56. doi:10.1056/NEJMoa1804980.
- Fowler NH, Dickinson M, Dreyling M, et al. Tisagenlecleucel in Adult Relapsed or Refractory Follicular Lymphoma: The Phase 2 ELARA Trial. Nat Med. 2022;28(2):325–332. doi:10.1038/s41591-021-01622-0.
- U.S. Food and Drug Administration (FDA). Kymriah (tisagenlecleucel) Prescribing Information. Initial approval: August 2017. Revised 2024.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Acute Lymphoblastic Leukemia. Version 2.2025.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas. Version 5.2025.
- Lee DW, Santomasso BD, Locke FL, et al. ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells. Biol Blood Marrow Transplant. 2019;25(4):625–638. doi:10.1016/j.bbmt.2018.12.758.
- World Health Organization (WHO). WHO Model List of Essential Medicines. 23rd list, 2023. Geneva: WHO.
Editorial Team
This article was prepared by the iMedic Medical Editorial Team, comprising board-certified specialists in oncology, haematology, and clinical pharmacology. Our editorial process follows established medical guidelines from the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), National Comprehensive Cancer Network (NCCN), and the World Health Organization (WHO).
All content is reviewed by independent medical experts following the GRADE evidence framework and international oncology guidelines.
iMedic receives no pharmaceutical funding. All content is editorially independent and free from commercial influence.