YESCARTA (Axicabtagene Ciloleucel)
CAR T-Cell Gene Therapy for B-Cell Lymphoma and Follicular Lymphoma
YESCARTA (axicabtagene ciloleucel) is a groundbreaking CAR T-cell gene therapy used to treat adults with certain types of aggressive B-cell non-Hodgkin lymphoma and follicular lymphoma. It is a personalized, one-time treatment made from the patient's own genetically modified white blood cells, designed to target and destroy cancer cells expressing the CD19 protein.
Quick Facts
Key Takeaways
- YESCARTA is a one-time, personalized CAR T-cell gene therapy manufactured from the patient's own white blood cells to target CD19-positive cancer cells.
- It is approved for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma (FL).
- Cytokine release syndrome (CRS) and neurologic toxicities (ICANS) are serious but manageable side effects that require close monitoring at a qualified treatment centre.
- Patients must remain near the treatment centre for at least 4 weeks after infusion and should not drive for at least 8 weeks.
- Clinical trials have demonstrated durable complete responses in approximately 40% of patients with aggressive lymphoma, offering hope for patients who have exhausted other treatment options.
What Is YESCARTA and What Is It Used For?
Quick Answer: YESCARTA is a CAR T-cell gene therapy that uses the patient's own genetically modified white blood cells to target and destroy cancer cells. It is used to treat adults with aggressive diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma that has not responded to or has returned after other treatments.
YESCARTA (axicabtagene ciloleucel) represents a revolutionary approach to cancer treatment known as chimeric antigen receptor (CAR) T-cell therapy. Unlike conventional chemotherapy or radiation, which broadly attack fast-dividing cells, YESCARTA harnesses the patient's own immune system to precisely target cancer cells. This treatment belongs to the broader category of gene therapies, as it involves the genetic modification of the patient's T cells to equip them with a synthetic receptor capable of recognizing a specific protein called CD19 found on the surface of B lymphocytes.
The therapy is specifically approved for the treatment of adult patients with several types of B-cell non-Hodgkin lymphoma. These include diffuse large B-cell lymphoma (DLBCL), the most common type of aggressive non-Hodgkin lymphoma worldwide, which accounts for approximately 30-40% of all non-Hodgkin lymphoma cases. YESCARTA is also indicated for primary mediastinal large B-cell lymphoma (PMBCL), a relatively rare subtype that typically affects younger adults and arises in the thymus gland, and for follicular lymphoma (FL), an indolent but often relapsing form of B-cell lymphoma.
In all approved indications, YESCARTA is reserved for patients whose disease has either relapsed after initial treatment or proven refractory (resistant) to standard therapies. For DLBCL and PMBCL, this typically means the cancer has not responded to or has come back after at least two lines of systemic therapy. For follicular lymphoma, YESCARTA may be considered after two or more prior lines of treatment. The decision to use YESCARTA is made by a specialized medical team at a qualified treatment centre with expertise in cell-based therapies and the management of their associated toxicities.
How YESCARTA Works
The mechanism of action of YESCARTA is fundamentally different from traditional cancer therapies. The treatment process begins with a procedure called leukapheresis, in which a portion of the patient's blood is drawn through a catheter and passed through a machine that separates out white blood cells (T cells). The remaining blood components are returned to the patient. This collected sample of T cells is then shipped to a specialized manufacturing facility.
At the manufacturing facility, the patient's T cells are genetically modified using a retroviral vector to express a chimeric antigen receptor (CAR) on their surface. This synthetic receptor is specifically designed to recognize the CD19 protein, which is present on the surface of both normal and malignant B lymphocytes. The CAR construct in YESCARTA includes an anti-CD19 single-chain variable fragment (scFv) for target recognition, linked to CD28 and CD3-zeta co-stimulatory domains that activate the T cell upon binding to its target.
Once the modified CAR T cells are infused back into the patient's bloodstream, they actively seek out and bind to any cell expressing CD19. Upon binding, the CAR T cells become activated, proliferate rapidly, and release cytotoxic molecules that destroy the target cancer cells. This process also triggers the release of cytokines, signaling molecules that amplify the immune response. The CAR T cells can persist in the body for months or even years after infusion, providing ongoing surveillance against any remaining or recurring CD19-positive cancer cells.
What Should You Know Before Receiving YESCARTA?
Quick Answer: Before receiving YESCARTA, your doctor will perform comprehensive assessments including blood tests, heart, lung, and kidney evaluations, and infection screening. You should not receive YESCARTA if you are allergic to its components or cannot tolerate lymphodepleting chemotherapy. Certain conditions, including active infections and neurological problems, require special consideration.
Contraindications
YESCARTA should not be administered to patients who have a known allergy (hypersensitivity) to axicabtagene ciloleucel or any of the other ingredients in the formulation, including dimethyl sulfoxide (DMSO). Additionally, patients who cannot receive lymphodepleting chemotherapy, which is a mandatory pre-treatment step required to prepare the body for the CAR T cells, are not eligible for YESCARTA treatment.
Because YESCARTA is an autologous product, meaning it is manufactured exclusively from the patient's own cells, it must never be administered to any other person. Each dose is uniquely manufactured for and can only be given to the individual patient from whom the cells were originally collected.
Warnings and Precautions
Before initiating YESCARTA treatment, patients must disclose their complete medical history to their treating physician. Several conditions warrant particular attention and may require additional monitoring or management strategies during treatment. Patients should inform their doctor if they have any of the following conditions or circumstances:
- Neurological disorders: History of seizures, stroke, memory loss, or other problems affecting the nervous system, as YESCARTA can cause neurologic toxicities.
- Kidney problems: Pre-existing renal impairment may affect how the body handles the treatment and its side effects.
- Low blood cell counts: Existing cytopenias may be worsened by lymphodepleting chemotherapy and the treatment itself.
- Recent stem cell transplant: Patients who have undergone a stem cell transplant within the preceding 4 months require careful evaluation.
- Cardiovascular or pulmonary conditions: Heart problems, lung disease, or blood pressure abnormalities (high or low) can increase the risk of complications, particularly during cytokine release syndrome.
- Graft-versus-host disease (GvHD): Signs or symptoms of GvHD, which can occur when transplanted cells attack the recipient's body, must be identified and managed before treatment.
- Active or recent infections: Any ongoing infection must be treated and resolved before YESCARTA infusion. History of hepatitis B, hepatitis C, or HIV infection requires specific screening and evaluation.
- Worsening cancer symptoms: If disease symptoms are rapidly progressing, the treating team needs to assess whether the patient remains an appropriate candidate for therapy.
Cases of new cancers, including T-cell malignancies, have been reported in patients treated with YESCARTA and similar CAR T-cell products. Patients should report any new swelling of lymph nodes or changes in the skin, such as new growths or lumps, to their doctor promptly. Long-term monitoring for secondary malignancies is recommended.
Tests and Assessments Before Treatment
Prior to receiving YESCARTA, the treating physician will conduct a comprehensive series of evaluations. These assessments are critical for ensuring patient safety and optimizing treatment outcomes. The pre-treatment workup typically includes:
- Assessment of lung, heart, kidney function, and blood pressure
- Screening for signs of active infection or inflammation
- Evaluation of cancer disease status and progression
- Screening for graft-versus-host disease in patients with prior transplant history
- Blood tests for uric acid levels and circulating tumor cells (to assess tumor lysis syndrome risk)
- Hepatitis B, hepatitis C, and HIV testing
- Review of vaccination history (no live vaccines within 6 weeks prior to lymphodepleting chemotherapy)
- Assessment for prior anti-CD19 directed therapies
Pregnancy and Breastfeeding
The effects of YESCARTA on pregnancy and the developing fetus are unknown. Patients who are pregnant, breastfeeding, suspect they may be pregnant, or are planning to become pregnant should consult their doctor before receiving this treatment. A pregnancy test is required before treatment initiation, and YESCARTA can only be administered if the test confirms the patient is not pregnant.
It is not known whether YESCARTA components can pass into breast milk or what effects they might have on a breastfed infant. Patients should discuss the risks and benefits of breastfeeding with their healthcare provider after receiving YESCARTA treatment.
Driving and Operating Machinery
YESCARTA can cause fatigue, dizziness, confusion, and tremors that may impair the ability to drive or operate machinery safely. Patients are advised not to drive, ride a bicycle, or operate heavy machinery for a minimum of 8 weeks after infusion, or until their treating physician confirms that they have fully recovered.
How Does YESCARTA Interact with Other Drugs?
Quick Answer: YESCARTA's efficacy can be impaired by immunosuppressive medications, particularly corticosteroids, if given before infusion. Live vaccines are contraindicated before and during treatment, and for an extended period while the immune system recovers. Tocilizumab is used specifically to manage cytokine release syndrome when it occurs.
Because YESCARTA is a living cell therapy rather than a conventional pharmaceutical drug, its interaction profile differs fundamentally from traditional medications. The modified T cells can be affected by drugs that alter immune function, and the immunocompromised state that results from treatment creates important considerations for concomitant medications.
| Drug / Drug Class | Interaction Type | Clinical Significance |
|---|---|---|
| Corticosteroids | May impair CAR T-cell function | Avoid systemic corticosteroids before infusion. May be used to manage CRS/ICANS after infusion under medical supervision. |
| Live vaccines | Contraindicated | Do not administer live vaccines for at least 6 weeks before lymphodepleting chemotherapy, during treatment, or while the immune system is recovering. |
| Tocilizumab | Used to manage CRS | Must be available on-site before infusion. Given as IL-6 receptor antagonist to treat cytokine release syndrome symptoms. |
| Immunosuppressive agents | May reduce CAR T-cell efficacy | Immunosuppressive medications should be avoided or minimized, as they may impair the expansion and function of CAR T cells. |
| Anticoagulants / Antiplatelets | Increased bleeding risk | Use with caution due to treatment-induced thrombocytopenia. Monitor platelet counts closely and adjust anticoagulation as needed. |
Patients should provide their treating team with a complete and current list of all medications they are taking, including prescription drugs, over-the-counter medications, herbal supplements, and vitamins. This comprehensive medication reconciliation is essential for safe treatment planning and management of potential interactions.
What Is the Correct Dosage of YESCARTA?
Quick Answer: YESCARTA is given as a single intravenous infusion at a target dose of 2 × 106 anti-CD19 CAR-positive viable T cells per kilogram of body weight. The entire treatment process, from cell collection (leukapheresis) to infusion, typically takes 3-4 weeks. It is administered only once.
The Treatment Process
YESCARTA treatment follows a carefully coordinated multi-step process that takes place over several weeks. Understanding each phase helps patients prepare for what to expect throughout their treatment journey.
Step 1: Leukapheresis (Cell Collection)
Your doctor will collect a portion of your blood through a catheter placed in a vein. A machine separates out your white blood cells while the remaining blood is returned to your body. This procedure takes approximately 3-6 hours and may need to be repeated. The collected white blood cells are sent to a manufacturing facility to create your personalized YESCARTA treatment.
Step 2: Manufacturing (3-4 Weeks)
At the manufacturing facility, your T cells are genetically modified to express the anti-CD19 chimeric antigen receptor. The cells are expanded, quality tested, and cryopreserved. This process typically takes approximately 3-4 weeks, though the time can vary.
Step 3: Lymphodepleting Chemotherapy
Before receiving YESCARTA, you will receive a short course of chemotherapy to reduce the number of white blood cells in your blood. This creates a favorable environment for the CAR T cells to expand and function effectively once infused. If the YESCARTA infusion is delayed more than two weeks after completing lymphodepleting chemotherapy, additional chemotherapy may be required.
Step 4: YESCARTA Infusion
YESCARTA is administered as a single intravenous infusion over approximately 30 minutes. Before infusion, you may receive paracetamol (acetaminophen) and an antihistamine such as diphenhydramine to help prevent infusion reactions and fever. The target dose is 2 × 106 anti-CD19 CAR-positive viable T cells per kilogram of body weight, delivered in approximately 68 ml of cell dispersion.
Step 5: Post-Infusion Monitoring
After receiving YESCARTA, you must remain near the qualified treatment centre for a minimum of 4 weeks. Your doctor will recommend daily hospital visits for at least the first 7 days and may require you to remain as an inpatient during this period. This intensive monitoring allows for early detection and management of potential complications, particularly cytokine release syndrome and neurologic toxicities.
Special Populations
| Patient Group | Dosage | Notes |
|---|---|---|
| Adults (18+ years) | 2 × 106 CAR T cells/kg (single infusion) | Standard target dose. Maximum of 2 × 108 CAR T cells total. |
| Children and adolescents (<18 years) | Not applicable | YESCARTA has not been studied in patients under 18 years of age and is not approved for this population. |
| Elderly | Same as adult dose | No dose adjustment required for elderly patients. Clinical trials included patients up to 76 years of age. |
| Renal impairment | Same as adult dose | No formal dose adjustment studies. Closely monitor kidney function during treatment. |
| Hepatic impairment | Same as adult dose | No formal dose adjustment studies. Liver function should be monitored closely. |
Missed Appointments
If you miss a scheduled visit during the post-infusion monitoring period, contact your doctor or the qualified treatment centre as soon as possible to arrange a new appointment. Consistent monitoring is essential during the first weeks after YESCARTA infusion, as complications can arise suddenly and require immediate medical intervention.
What Are the Side Effects of YESCARTA?
Quick Answer: YESCARTA can cause serious side effects, most notably cytokine release syndrome (CRS) and neurologic toxicities (ICANS). Other very common side effects include infections, low blood cell counts, fever, fatigue, nausea, and low blood pressure. These side effects require close monitoring and may be life-threatening if not promptly managed.
Like all medicines, YESCARTA can cause side effects, although not everybody gets them. Some side effects can be serious or life-threatening and require immediate medical attention. The unique mechanism of CAR T-cell therapy means that the side effect profile of YESCARTA differs significantly from conventional cancer therapies. The activation and rapid expansion of modified T cells can trigger systemic inflammatory responses that need careful management by experienced medical teams.
Contact your doctor immediately or seek emergency medical care if you experience: high fever with chills, low blood pressure, rapid or irregular heartbeat, difficulty breathing, seizures, confusion, loss of consciousness, severe tremors, difficulty speaking, or signs of infection. These may indicate CRS, neurologic toxicity, or severe infection requiring urgent treatment.
Cytokine Release Syndrome (CRS)
Cytokine release syndrome is the most significant and common serious side effect of YESCARTA. It occurs when the activated CAR T cells release large quantities of cytokines (inflammatory signaling molecules) into the bloodstream, triggering a widespread inflammatory response. CRS typically develops within the first 1-12 days after infusion and can range from mild (low-grade fever) to life-threatening (multi-organ failure).
Symptoms of CRS include fever, chills, low blood pressure (hypotension), rapid heartbeat (tachycardia), irregular heartbeat (arrhythmia), low blood oxygen levels, and difficulty breathing. Patients are advised to measure their temperature twice daily for 3-4 weeks after treatment. Any elevation in temperature should prompt immediate medical contact. CRS is managed with tocilizumab, an interleukin-6 (IL-6) receptor antagonist, and supportive care including fluids, vasopressors, and supplemental oxygen as needed.
Neurologic Toxicities (ICANS)
Immune effector cell-associated neurotoxicity syndrome (ICANS) is another serious complication that can occur with YESCARTA treatment. Neurologic toxicities may occur concurrently with CRS or independently, and can manifest as confusion, disorientation, agitation, hallucinations, difficulty speaking or understanding speech (aphasia), tremors, seizures, reduced consciousness, or loss of coordination. In rare cases, cerebral edema has been reported. Neurologic toxicities are managed with corticosteroids and supportive care, and most cases resolve within weeks, though some may be prolonged.
Side Effects by Frequency
Very Common (may affect more than 1 in 10 people)
- Cytokine release syndrome (CRS) – fever, chills, low blood pressure, rapid heartbeat, difficulty breathing
- Encephalopathy – confusion, reduced consciousness, memory loss, difficulty speaking
- Infections (bacterial and viral) – due to low white blood cell counts or low immunoglobulin levels
- Decreased red blood cells (anaemia) – extreme tiredness, weakness, shortness of breath
- Low platelet counts (thrombocytopenia) – excessive bleeding or bruising
- Low sodium or phosphate levels in blood
- Elevated uric acid or blood sugar levels
- Decreased appetite
- Difficulty sleeping (insomnia)
- Headache and dizziness
- Rapid heartbeat (tachycardia) and arrhythmia
- Low blood pressure (hypotension) and high blood pressure (hypertension)
- Cough
- Nausea, constipation, diarrhoea, abdominal pain, vomiting
- Elevated liver enzymes
- Skin rash or skin problems
- Muscle and joint pain, back pain
- Fluid accumulation (oedema) – swelling, weight gain, decreased urine output
- Excessive fatigue
Common (may affect up to 1 in 10 people)
- Seizures (convulsions), including prolonged and potentially life-threatening episodes
- Cardiac arrest or heart failure
- Blood clots – chest pain, difficulty breathing, swelling of a leg
- Respiratory failure – inability to breathe independently
- Kidney failure with fluid retention
- Pulmonary oedema (fluid in the lungs)
- Fungal infections
- Coagulation disorders (coagulopathy)
- Hypersensitivity reactions – rash, hives, itching, swelling, anaphylaxis
- Low albumin, potassium, or calcium levels
- Dehydration and weight loss
- Anxiety and mood disturbances
- Facial muscle weakness (facial nerve palsy)
- Hand or foot pain (peripheral neuropathy) and muscle spasm
- Visual impairment
- Pleural effusion (fluid around the lungs)
- Dry mouth and difficulty swallowing
- Elevated bilirubin levels
- Infusion-related reactions – dizziness, flushing, rash, fever, shortness of breath
Uncommon (may affect up to 1 in 100 people)
- Severe systemic inflammatory condition (haemophagocytic lymphohistiocytosis/macrophage activation syndrome)
- Multi-organ failure – simultaneous dysfunction of two or more organs
- Paralysis of all four limbs (quadriplegia)
- Spinal cord swelling (myelitis) – potentially causing partial or total paralysis
- Difficulty understanding numbers (acalculia)
- Rhabdomyolysis (muscle tissue breakdown)
- Secondary T-cell malignancy
In rare cases, a serious brain condition called PML has been reported after CAR T-cell therapy. Symptoms include blurred vision, vision loss, double vision, difficulty speaking, weakness in a limb, changes in walking or balance, personality changes, and progressive changes in thinking and memory. These symptoms may develop gradually over weeks or months after treatment. It is important that family members and caregivers are also aware of these symptoms, as they may notice changes that the patient does not.
Long-Term Considerations
Because YESCARTA targets CD19-expressing cells, it also depletes normal B cells, which are essential for antibody production. This can lead to prolonged hypogammaglobulinemia (low immunoglobulin levels), increasing susceptibility to infections. Some patients may require intravenous immunoglobulin (IVIG) replacement therapy for an extended period. Your doctor will regularly monitor your blood counts and immunoglobulin levels, as these may take several months to recover.
Patients may be asked to enroll in a long-term follow-up registry for at least 15 years after YESCARTA treatment. This registry helps researchers understand the long-term effects and outcomes of CAR T-cell therapy. Additionally, patients who have received YESCARTA should not donate blood, organs, tissues, or cells for transplantation.
How Should YESCARTA Be Stored?
Quick Answer: YESCARTA must be stored in the vapor phase of liquid nitrogen at ≤ -150°C until thawed for use. It can be temporarily stored at -80°C (± 10°C) for up to 90 days. Storage and handling are managed entirely by the healthcare facility; patients do not handle this product.
The storage and handling of YESCARTA are managed exclusively by qualified healthcare professionals at the treatment centre. Unlike conventional medications that patients may store at home, YESCARTA is a cryopreserved living cell product that requires specialized ultra-cold storage facilities. Patients do not need to concern themselves with storage logistics, but understanding the storage requirements provides insight into the complexity of this therapy.
YESCARTA must be stored in the vapor phase of liquid nitrogen at a temperature not exceeding -150°C until it is ready to be thawed for administration. The product may be stored once at -80°C (± 10°C) for up to 90 days. After storage at -80°C, the product must be used within 90 days or by the labelled expiry date, whichever comes first. Once thawed, YESCARTA must not be refrozen and should be administered within 30 minutes of completing the thawing process. At room temperature (20-25°C), the thawed product remains stable for up to 3 hours.
What Does YESCARTA Contain?
Quick Answer: YESCARTA contains the patient's own genetically modified anti-CD19 CAR T cells suspended in a cryopreservation solution. Each single-use infusion bag contains approximately 68 ml of cell dispersion at a target dose of 2 × 106 anti-CD19 CAR-positive viable T cells per kilogram of body weight.
The active substance in YESCARTA is axicabtagene ciloleucel, which consists of the patient's own T cells that have been genetically modified to express an anti-CD19 chimeric antigen receptor. Each patient-specific single-use infusion bag contains a dispersion of these modified cells in approximately 68 ml of solution. Because this is an autologous product, the exact composition varies between patients, but each bag is manufactured to meet a target dose of 2 × 106 anti-CD19 CAR-positive viable T cells per kilogram of body weight.
The other ingredients (excipients) include CryoStor CS10 (which contains DMSO), sodium chloride, and human albumin. The product contains approximately 300 mg of sodium per infusion, equivalent to 15% of the WHO-recommended maximum daily sodium intake for an adult. YESCARTA also contains DMSO and trace amounts of gentamicin, which can potentially cause severe allergic reactions in sensitive individuals. The product appears as a clear to opaque, white to red dispersion and is supplied in an infusion bag individually packaged in a metal cassette.
YESCARTA contains genetically modified human blood cells. Healthcare professionals handling the product must take appropriate precautions (wearing protective gloves and eye protection) to prevent potential transmission of infectious diseases. All materials that have been in contact with YESCARTA must be handled and disposed of as potentially infectious waste in accordance with local biosafety guidelines.
Frequently Asked Questions About YESCARTA
YESCARTA is fundamentally different from traditional chemotherapy. While chemotherapy uses chemical drugs to kill rapidly dividing cells (both cancerous and healthy), YESCARTA is a living cell therapy that reprograms your own immune cells to specifically target cancer cells expressing the CD19 protein. Unlike chemotherapy, which typically requires multiple cycles, YESCARTA is given as a single, one-time infusion. The treatment is personalized for each patient, manufactured from their own T cells, and can provide long-lasting anti-cancer surveillance.
The manufacturing process typically takes approximately 3-4 weeks from the time your white blood cells are collected (leukapheresis) until the finished product is ready for infusion. During this time, your T cells are shipped to a specialized manufacturing facility, genetically modified to express the CAR receptor, expanded to therapeutic quantities, tested for quality and safety, and cryopreserved for shipment back to your treatment centre. Your doctor may provide bridging therapy during this waiting period if needed to manage your cancer.
Cytokine release syndrome (CRS) is a systemic inflammatory response caused by the activation and expansion of CAR T cells in the body. When the modified T cells encounter and begin destroying cancer cells, they release large amounts of cytokines (chemical messengers), triggering widespread inflammation. Symptoms range from mild fever and fatigue to severe low blood pressure, difficulty breathing, and organ dysfunction. CRS is treated primarily with tocilizumab (an IL-6 receptor blocker), along with supportive care including IV fluids, vasopressors for blood pressure support, and oxygen supplementation. Most patients experience CRS within the first 1-12 days after infusion, and it typically resolves within 1-2 weeks with appropriate management.
YESCARTA is designed and approved as a single, one-time infusion. The treatment is not intended for repeated administration. If a patient does not respond to YESCARTA or relapses after treatment, the treating physician will discuss alternative treatment options, which may include other immunotherapies, clinical trials, or conventional treatments. The decision regarding subsequent therapies will depend on the individual patient's disease characteristics, prior treatment history, and overall health status.
Live vaccines must not be given for at least 6 weeks before lymphodepleting chemotherapy, during YESCARTA treatment, and while your immune system is recovering after treatment. This includes vaccines such as MMR (measles, mumps, rubella), varicella (chickenpox), yellow fever, and live influenza nasal spray. Inactivated vaccines may be considered, but their effectiveness may be reduced due to the immunocompromised state following treatment. Your doctor will advise you on when it is safe to resume any vaccination schedule and which vaccines are appropriate for your situation.
No, YESCARTA is not approved for use in children and adolescents under 18 years of age, as it has not been studied in this population. Other CAR T-cell therapies, such as tisagenlecleucel (Kymriah), are approved for pediatric patients with certain types of B-cell acute lymphoblastic leukemia. If you are seeking CAR T-cell therapy for a child, speak with a pediatric oncologist about available options and clinical trials.
References
- European Medicines Agency (EMA). YESCARTA (axicabtagene ciloleucel) – Summary of Product Characteristics. Available at: ema.europa.eu/EPAR/yescarta. Accessed January 2026.
- U.S. Food and Drug Administration (FDA). YESCARTA Prescribing Information. Kite Pharma, Inc. Approved October 2017, revised 2024.
- Neelapu SS, Locke FL, Bartlett NL, et al. Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma (ZUMA-1). N Engl J Med. 2017;377(26):2531-2544. doi:10.1056/NEJMoa1707447
- Locke FL, Ghobadi A, Jacobson CA, et al. Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1-2 trial. Lancet Oncol. 2019;20(1):31-42.
- Jacobson CA, Chavez JC, Sehgal AR, et al. Axicabtagene ciloleucel in relapsed or refractory indolent non-Hodgkin lymphoma (ZUMA-5): a single-arm, multicentre, phase 2 trial. Lancet Oncol. 2022;23(1):91-103.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas. Version 1.2026.
- 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.
- World Health Organization (WHO). WHO Model List of Essential Medicines. 23rd list, 2023. Geneva: World Health Organization.
Editorial Team
Written by the iMedic Medical Editorial Team – specialists in oncology, hematology, and cell-based therapies with clinical and academic expertise.
Reviewed by the iMedic Medical Review Board – an independent panel ensuring accuracy, evidence quality, and adherence to EMA, FDA, and NCCN guidelines.
This article was last medically reviewed on . All medical claims are supported by peer-reviewed research and international clinical guidelines (Evidence Level 1A). iMedic receives no pharmaceutical company funding or advertising revenue.