Yescarta
Pronunciation: yes-kar-ta
Generic name: axicabtagene ciloleucel
Dosage form: suspension for intravenous infusion
Drug class: Miscellaneous antineoplastics
What is Yescarta?
Yescarta is used to treat large B-cell lymphoma and follicular lymphoma (FL) in adults. It is a personalized cancer treatment that is made from your immune system's T-cells and is given as a one-time intravenous infusion over 30 minutes. You will receive 3 days of chemotherapy before you get Yescarta, to prepare your body for the infusion.
To make Yescarta, your doctor first collects your T-cells, then sends them to a laboratory where they are enhanced by adding a special receptor called a chimeric antigen receptor (CAR). This improves the ability of these T-cells to target and attach to cancer cells that display a protein called CD19. Once attached, the modified T-cells destroy cancer cells, which strengthens your immune system's overall ability to fight cancer. Yescarta belongs to the drug class called CAR T-cell therapy.
Yescarta (axicabtagene ciloleucel) gained FDA approval on October 18, 2017. There is no generic. The Risk Evaluation and Mitigation Strategy (REMS) requirement for Yescarta was removed on June 27, 2025.
Approval for Yescarta was based on positive results from clinical trials, including the following:
- ZUMA-1 (NCT02348216). Phase 1/2 trial of patients with refractory large B-cell lymphoma (LBCL) who had failed two or more lines of therapy. Key results were an 83% objective response rate (ORR), a 58% complete response (CR) rate, and a 5-year overall survival (OS) rate of 43%.
- Follow-up to ZUMA-1. Among treated patients alive at five years, 92% had received no additional treatment since their one-time infusion of Yescarta, suggestive of a cure for these patients.
- ZUMA-7 (NCT03391466). Phase 3 trial of relapsed or refractory LBCL within 12 months of first-line therapy. Key Results: 27.4% reduction in the risk of death and superiority of Yescarta compared with standard of care autologous stem cell transplant after meeting the primary end point of event-free survival improvement.
FDA approvals and uses
Yescarta is approved for adults with:
- Large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy
- Relapsed or refractory large B-cell lymphoma after 2 or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma
- Relapsed or refractory follicular lymphoma (FL) after 2 or more lines of systemic therapy. This indication is approved based on the response rate. Continued approval for this indication may be contingent upon verification and description of a clinical benefit being shown in confirmatory trials.
Yescarta is not for use in patients with primary central nervous system lymphoma.
Side effects
The most common side effects of Yescarta are:
- fever (100.4°F/38°C or higher)
- low white blood cells (can occur with a fever)
- low red blood cells
- low blood pressure (dizziness or lightheadedness, headache, feeling tired, short of breath)
- fast heartbeat
- confusion
- difficulty speaking or slurred speech
- nausea
- diarrhea.
Yescarta may increase your risk of getting cancers, including certain types of blood cancers. Your healthcare provider should monitor you for this.
Serious side effects and warnings
Yescarta carries a Boxed Warning for cytokine release syndrome, neurologic toxicities, and secondary blood cancers.
Cytokine Release Syndrome (CRS): A potentially life-threatening condition where the immune system overreacts and releases excessive amounts of cytokines, leading to widespread inflammation and organ dysfunction. Tell your healthcare provider immediately if you develop symptoms such as fever, low blood pressure, trouble breathing, or vomiting. Talk to your healthcare provider about having medication available to quickly treat this condition.
Brain/Nervous System Effects: The treatment can cause confusion, seizures, difficulty speaking, or other brain problems. These neurological symptoms can be serious or fatal.
T Cell Cancer Risk: Rarely, the modified immune cells used in treatment can themselves become cancerous, creating a new type of blood cancer different from the original disease being treated.
Call or see your healthcare provider or get emergency help right away if you get any of the following:
- fever (100.4°F/38°C or higher)
- difficulty breathing
- chills or shaking chills
- confusion
- dizziness or lightheadedness
- severe nausea, vomiting, or diarrhea
- fast or irregular heartbeat
- severe fatigue or weakness.
Tell all your healthcare providers that you have received Yescarta and show them your Yescarta Patient Wallet Card. Your healthcare provider may give you other medicines to treat your side effects. Yescarta is different than other cancer medicines because it is made from your white blood cells, which have been modified to recognize and attack your lymphoma cells.
Yescarta may also cause other serious side effects:
- Hypersensitivity (allergic) reactions, including anaphylaxis, may occur during a Yescarta infusion. These may be due to dimethyl sulfoxide (DMSO) or the residual gentamicin in the infusion
- Serious infections
- Life-threatening nerve problems. including encephalopathy (a disturbance in your brain function), headache, tremor, dizziness, speech difficulties, delirium, and insomnia
- Prolonged cytopenias (low blood cell levels), such as neutropenia, thrombocytopenia, and anemia, may persist for several weeks following a Yescarta infusion
- Low levels of immunoglobulins in your blood (hypogammaglobulinemia) and B-cell aplasia can occur in Yescarta-treated patients. Your healthcare provider will monitor your immunoglobulin levels.
These are not all the possible side effects of Yescarta. Call your healthcare provider about any side effects that concern you. You may report side effects to the FDA at 1-800-FDA-1088.
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Before receiving this medicine
Before receiving Yescarta, tell your healthcare provider about all your medical problems, including if you have or have had:
- neurologic problems (such as seizures, stroke, or memory loss)
- lung or breathing problems
- heart problems
- liver problems
- kidney problems
- a recent or active infection
- are pregnant or intend to become pregnant
- are breastfeeding.
Also, tell your doctor if you have received a vaccine in the past 2 weeks. Vaccination with live virus vaccines is not recommended for at least 6 weeks before the start of lymphodepleting chemotherapy, during treatment, and until your immune system recovers following treatment with Yescarta.
Pregnancy
If you are a woman of childbearing potential, your healthcare provider may conduct pregnancy testing before receiving this medicine. You may also need to use birth control to prevent pregnancy during and shortly after treatment with Yescarta and chemotherapy.
If you receive Yescarta during pregnancy, your baby's blood may need to be tested after it is born. This is to evaluate any effects the medicine may have had on the baby.
Breastfeeding
It may not be safe to breastfeed while using this medicine. Ask your doctor about any risks.
How will I receive Yescarta?
Since Yescarta is made from your white blood cells, your blood will be collected by a process called “leukapheresis” (loo-kah-fur-ee-sis), which will concentrate your white blood cells.
- Your blood cells will be sent to a manufacturing center to make your Yescarta.
- Before you get Yescarta, you will get 3 days of chemotherapy to prepare your body.
When your Yescarta is ready, your healthcare provider will give it to you through a catheter placed into your vein (intravenous infusion). The infusion usually takes less than 30 minutes.
- You will be monitored where you received your treatment daily for at least 7 days after the infusion.
- You should plan to stay close to a certified healthcare facility for at least 4 weeks after getting Yescarta. Your healthcare provider will help you with any side effects that may occur.
- You may be hospitalized for side effects, and your healthcare provider will discharge you if your side effects are under control and it is safe for you to leave the hospital.
- Your healthcare provider will want to do blood tests to follow your progress. If you miss an appointment, call your healthcare provider as soon as possible to reschedule.
Dosing Information
Dose of Yescarta for large B-cell lymphoma or FL in adults
Three days before your Yescarta infusion, you will receive a lymphodepleting regimen of cyclophosphamide and fludarabine.
On the day of your infusion, your healthcare provider will:
- Verify your identity
- Premedicate with acetaminophen and an H1-antihistamine
- Confirm the availability of tocilizumab before infusion
- Infuse a target Yescarta dose of 2 × 106 CAR-positive viable T cells per kg body weight, with a maximum of 2 × 108 CAR-positive viable T cells, within 30 minutes.
What should I avoid after receiving Yescarta?
Avoid driving for at least 2 weeks after you get Yescarta.
Do not donate blood, organs, tissues, or cells for transplantation.
What other drugs will affect Yescarta?
Tell your doctor about all your current medicines and any medicine you start or stop using. Other drugs may interact with Yescarta, including prescription and over-the-counter medicines, vitamins, and herbal products.
- Systemic corticosteroids may interfere with the activity of this drug.
See the Yescarta Prescribing Information for a complete list of interactions.
Ingredients
Active: axicabtagene ciloleucel
Inactive: albumin (human), DMSO (dimethylsulfoxide).
Yescarta is supplied in an infusion bag (NDC 71287-119-01) containing approximately 68 mL of frozen suspension of genetically modified autologous T cells in 5% DMSO and 2.5% albumin (human).
The target Yescarta dose contains 2 × 106 CAR-positive viable T cells per kg of body weight, with a maximum of 2 × 108 CAR-positive viable T cells in approximately 68 mL.
Manufacturer
Yescarta is made by Kite Pharma, Inc., Santa Monica, CA 90404.
Popular FAQ
What is the cost of Yescarta?
The cost of Yescarta is about $424,000 per treatment regimen, but most people do not pay this amount. Your insurance or the manufacturer may cover many of the costs for this treatment. Each dose of Yescarta is a customized treatment created using a patient’s own immune system to help fight lymphoma (a type of blood cancer).
Continue readingWhat's the difference between Kymriah and Yescarta?
Kymriah and Yescarta are two cell-based gene therapies. A few differences between the two medications include who and what they are FDA approved for, their dosage, and which companies make them. Continue reading
How is Yescarta administered?
Yescarta (axicabtagene ciloleucel) is given through a catheter placed into your vein (intravenous infusion), typically in your arm. The infusion usually takes less than 30 minutes. It is given as a one-time infusion. It is a special infusion made just for you using your own white blood cells in a process called “leukapheresis” which will concentrate your white blood cells to help fight cancer.
Continue readingWhat type of drug is Yescarta (axicabtagene ciloleucel)?
Yescarta (axicabtagene ciloleucel) is a CD19-directed chimeric antigen receptor T cell (CAR T) therapy. It is a type of immunotherapy approved to treat adults with certain forms of large B-cell lymphoma or follicular lymphoma. In CAR T, a patient's T cells (type of white blood cell) are separated out and engineered to express a chimeric antigen receptor (CAR) to target the tumor antigen CD19.
Continue readingReferences
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