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WARNING
CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITIES
YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy. To prepare YESCARTA, a patient's own T cells are harvested and genetically modified ex vivo by retroviral transduction to express a chimeric antigen receptor (CAR) comprising a murine anti-CD19 single chain variable fragment (scFv) linked to CD28 and CD3-zeta co-stimulatory domains. The anti-CD19 CAR T cells are expanded and infused back into the patient, where they can recognize and eliminate CD19-expressing target cells.
YESCARTA is prepared from the patient's peripheral blood mononuclear cells, which are obtained via a standard leukapheresis procedure. The mononuclear cells are enriched for T cells and activated with anti-CD3 antibody in the presence of IL-2, then transduced with the replication incompetent retroviral vector containing the anti-CD19 CAR transgene. The transduced T cells are expanded in cell culture, washed, formulated into a suspension, and cryopreserved. The product must pass a sterility test before release for shipping as a frozen suspension in a patient-specific infusion bag. The product is thawed prior to infusion [see DOSAGE AND ADMINISTRATION, HOW SUPPLIED/Storage and Handling].
In addition to T cells, YESCARTA may contain NK and NK-T cells. The formulation contains 5% dimethylsulfoxide (DMSO) and 2.5% albumin (human).
YESCARTA is indicated for the treatment of:
YESCARTA is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
This indication is approved under accelerated approval based on response rate [see Clinical Studies (14.2)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
For autologous use only. For intravenous use only.
Each single infusion bag of YESCARTA contains a suspension of chimeric antigen receptor (CAR)-positive T cells in approximately 68 mL. The target dose is 2 × 10 CAR-positive viable T cells per kg body weight, with a maximum of 2 × 108 CAR-positive viable T cells.
YESCARTA is for autologous use only. The patient’s identity must match the patient identifiers on the YESCARTA cassette and infusion bag. Do not infuse YESCARTA if the information on the patient-specific label does not match the intended patient.
Confirm availability of YESCARTA prior to starting the lymphodepleting regimen.
Pre-treatment
Premedication
Coordinate the timing of YESCARTA thaw and infusion. Confirm the infusion time in advance, and adjust the start time of YESCARTA thaw such that it will be available for infusion when the patient is ready.
Identify CRS based on clinical presentation [see Warnings and Precautions (5.1)]. Evaluate for and treat other causes of fever, hypoxia, and hypotension. If CRS is suspected, manage according to the recommendations in Table 1. Patients who experience Grade 2 or higher CRS (e.g., hypotension not responsive to fluids, or hypoxia requiring supplemental oxygenation) should be monitored with continuous cardiac telemetry and pulse oximetry. For patients experiencing severe CRS, consider performing an echocardiogram to assess cardiac function. For severe or lifethreatening CRS, consider intensive-care supportive therapy. Physicians may also consider management per current practice guidelines.
Table 1. CRS Grading and Management Guidance
| CRS Gradea | Tocilizumab | Corticosteroids |
|---|---|---|
| Grade 1 Symptoms require symptomatic treatment only (e.g., fever, nausea, fatigue, headache, myalgia, malaise). |
If symptoms (e.g., fever) not improving after 24 hours, consider managing as Grade 2. | If not improving after 3 days, administer one dose of dexamethasone 10 mg intravenously. |
| Grade 2
Symptoms require and respond to moderate intervention. Oxygen requirement less than 40% FiO2 or hypotension responsive to fluids or low-dose of one vasopressor or Grade 2 organ toxicity. b |
Administer tocilizumabc 8 mg/kg intravenously over 1 hour (not to exceed 800 mg). If no clinical improvement in the signs and symptoms of CRS after the first dose, repeat tocilizumab every 8 hours as needed. Limit to a maximum of 3 doses in a 24- hour period; maximum total of 4 doses. If improving, discontinue tocilizumab. |
Administer dexamethasone 10 mg intravenously once daily. If improving, manage as Grade 1 above and continue corticosteroids until the severity is Grade 1 or less, then quickly taper as clinically appropriate. If not improving, manage as appropriate grade below. |
| Grade 3
Symptoms require and respond to aggressive intervention. Oxygen requirement greater than or equal to 40% FiO2 or hypotension requiring high-dose or multiple vasopressors or Grade 3 organ toxicity or Grade 4 transaminitis. |
Per Grade 2. If improving, manage as appropriate grade above. |
Dexamethasone 10 mg intravenously three times a day. If improving, manage as appropriate grade above and continue corticosteroids until the severity is Grade 1 or less, then quickly taper as clinically appropriate. If not improving, manage as Grade 4. |
| Grade 4
Life-threatening symptoms. Requirements for ventilator support, continuous veno-venous hemodialysis (CVVHD) or Grade 4 organ toxicity (excluding transaminitis). |
Per Grade 2. If improving, manage as appropriate grade above. |
Administer methylprednisolone 1000 mg intravenously once per day for 3 days. If improving, manage as appropriate grade above and continue corticosteroids until the severity is Grade 1 or less, then taper as clinically appropriate. If not improving, consider methylprednisolone 1000 mg 2-3 times a day or alternate therapy.d |
|
a. Lee et al. 2014. |
||
Monitor patients for signs and symptoms of neurologic toxicity/immune effector cell-associated neurotoxicity syndrome (ICANS) (Table 2). Rule out other causes of neurologic symptoms. Patients who experience Grade 2 or higher neurologic toxicities/ICANS should be monitored with continuous cardiac telemetry and pulse oximetry. Provide intensive-care supportive therapy for severe or life-threatening neurologic toxicities. Consider levetiracetam for seizure prophylaxis for any grade of neurologic toxicities. Physicians may also consider management per current practice guidelines.
Table 2. Neurologic Toxicity/ICANS Grading and Management Guidance
| Grading Assessmenta | Concurrent CRS | No Concurrent CRS |
|---|---|---|
| Grade 1 |
Administer tocilizumab per Table 1 for management of Grade 1 CRS. In addition, administer one dose of dexamethasone 10 mg intravenously. If not improving after 2 days, repeat dexamethasone 10 mg intravenously. |
Administer one dose of dexamethasone 10 mg intravenously. If not improving after 2 days, repeat dexamethasone 10 mg intravenously. |
| Consider levetiracetam for seizure prophylaxis. | ||
| Grade 2 |
Administer tocilizumab per Table 1 for management of Grade 2 CRS. In addition, administer dexamethasone 10 mg intravenously four times a day. If not improving after 2 days, repeat dexamethasone 10 mg intravenouslyIf improving, continue corticosteroids until the severity is Grade 1 or less, then quickly taper as clinically appropriate. If not improving, manage as appropriate grade below. |
Administer dexamethasone 10 mg intravenously four times a day. If improving, continue corticosteroids until the severity is Grade 1 or less, then quickly taper as clinically appropriate. If not improving, manage as appropriate grade below. |
| Consider levetiracetam for seizure prophylaxis. | ||
| Grade 3 |
Administer tocilizumab per Table 1 for management of Grade 2 CRS. In addition, administer methylprednisolone 1000 mg intravenously once daily. If improving, manage as appropriate grade above and continue corticosteroids until the severity is Grade 1 or less, then taper as clinically appropriate. If not improving, manage as Grade 4. |
Administer methylprednisolone 1000 mg intravenously once daily. If improving, manage as appropriate grade above and continue corticosteroids until the severity is Grade 1 or less, then taper as clinically appropriate. If not improving, manage as Grade 4. |
| Consider levetiracetam for seizure prophylaxis. | ||
| Grade 4 |
Administer tocilizumab per Table 1 for management of Grade 2 CRS. In addition, administer methylprednisolone 1000 mg intravenously twice per day. If improving, manage as appropriate grade above and continue corticosteroids until the severity is Grade 1 or less, then taper as clinically appropriate. If not improving, consider 1000 mg of methylprednisolone intravenously 3 times a day or alternate therapy.b |
Administer methylprednisolone 1000 mg intravenously twice per day. If improving, manage as appropriate grade above and continue corticosteroids until the severity is Grade 1 or less, then taper as clinically appropriate. If not improving, consider 1000 mg of methylprednisolone intravenously 3 times a day or alternate therapy.b |
| Consider levetiracetam for seizure prophylaxis. | ||
|
a. Severity based on Common Terminology Criteria for Adverse Events. |
||
YESCARTA is available as a cell suspension for infusion.
A single dose of YESCARTA contains 2 × 106 CAR-positive viable T cells per kg of body weight (or maximum of 2 × 108 CAR-positive viable T cells for patients 100 kg and above) in approximately 68 mL suspension in an infusion bag [see How Supplied/Storage and Handling (16)].
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).
Each YESCARTA infusion bag is individually packed in a metal cassette (NDC 71287-119-02). YESCARTA is stored in the vapor phase of liquid nitrogen and supplied in a liquid nitrogen dry shipper.
Manufactured by, Packed by, Distributed by:
Kite Pharma, Inc.
Santa Monica, CA 90404
US License No 2064
YESCARTA is a trademark of Kite Pharma, Inc. All other trademarks referenced herein are the property of their respective owners.
© 2025 Kite Pharma, Inc. All Rights Reserved
125643-GS-014
The following adverse reactions are described elsewhere in the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described in the WARNINGS AND PRECAUTIONS reflect exposure to a single dose of YESCARTA in one randomized, open-label study with 168 patients with relapsed or refractory LBCL (ZUMA-7) and two open-label, single-arm studies with 108 patients with relapsed or refractory LBCL (ZUMA-1 study) and 146 patients with relapsed or refractory iNHL (including 124 with FL; ZUMA-5 study).
The safety of YESCARTA was evaluated in ZUMA-7, a randomized, open-label, multicenter study in which patients with primary refractory LBCL or first relapse of LBCL received YESCARTA (N = 168) or standard therapy (N = 168) [see Clinical Studies]. Patients had not yet received treatment for relapsed or refractory lymphoma and were potential candidates for autologous HSCT. The trial excluded patients who were not deemed candidates for transplant or who had a history of central nervous system (CNS) disorders (such as seizures or cerebrovascular ischemia), serious or uncontrolled infection, or autoimmune disease requiring systemic immunosuppression. The study required ANC ≥ 1000/mm3, platelet count ≥ 75,000/mm3, creatinine clearance ≥ 60 ml/min, AST/ALT ≤ 2.5 x ULN, and total bilirubin ≤ 1.5 mg/dL.
The median age of the YESCARTA-treated safety population was 59 years (range: 21 to 80 years); 62% were male. The baseline Eastern Cooperative Oncology Group (ECOG) performance status was 0 in 54% of patients and 1 in 46%.
The most common non-laboratory adverse reactions to YESCARTA (incidence ≥ 20%) included fever, CRS, fatigue, hypotension, encephalopathy, tachycardia, diarrhea, headache, musculoskeletal pain, nausea, febrile neutropenia, chills, cough, infection with unspecified pathogen, dizziness, tremor, decreased appetite, edema, hypoxia, abdominal pain, aphasia, constipation, and vomiting. Serious adverse reactions occurred in 50% of patients. The most common serious adverse reactions (> 5%) included CRS, fever, encephalopathy, hypotension, infection with unspecified pathogen, and pneumonia. Fatal adverse reactions occurred in 2% of patients.
The most common (≥ 10%) Grade 3 or higher non-laboratory adverse reactions included febrile neutropenia, encephalopathy, and hypotension.
Sixty-seven percent (112/168) of patients received tocilizumab after infusion of YESCARTA.
Table 3 summarizes selected non-laboratory adverse reactions in patients treated with YESCARTA, and Table 4 summarizes selected new or worsening Grade 3 or 4 laboratory abnormalities.
Table 3. Adverse Reactions in ≥ 10% of Patients Treated with YESCARTA in ZUMA-7
| Adverse Reaction | YESCARTA N = 168 |
|
| Any Grade (%) | Grade 3 or Higher (%) | |
| Febrile neutropenia | 31 | 31 |
| Cardiac Disorders | ||
| Tachycardia a | 43 | 2 |
| Arrhythmia b | 14 | 3 |
| Gastrointestinal Disorders | ||
| Diarrhea c | 42 | 3 |
| Nausea | 40 | 2 |
| Abdominal pain d | 20 | 4 |
| Constipation | 20 | 0 |
| Vomiting | 20 | 0 |
| Dry Mouth | 10 | 0 |
| General Disorders and Administration Site Conditions | ||
| Fever e | 93 | 9 |
| Fatigue f | 52 | 7 |
| Chills | 28 | 1 |
| Edema g | 23 | 1 |
| Immune System Disorders | ||
| Cytokine release syndrome | 92 | 7 |
| Hypogammaglobulinemia | 11 | 0 |
| Infections and Infestations | ||
| Infections with pathogen unspecified | 25 | 8 |
| Viral infections | 15 | 4 |
| Bacterial infections | 10 | 5 |
| Fungal infections | 10 | 1 |
| Metabolism and Nutrition Disorders | ||
| Decreased appetite | 24 | 4 |
| Musculoskeletal and Connective Tissue Disorders | ||
| Musculoskeletal pain h | 40 | 1 |
| Motor dysfunction i | 15 | 4 |
| Nervous System Disorders | ||
| Encephalopathy j | 46 | 18 |
| Headache k | 41 | 3 |
| Tremor | 25 | 1 |
| Dizziness l | 25 | 4 |
| Aphasia | 20 | 7 |
| Neuropathy peripheral m | 11 | 2 |
| Psychiatric Disorders | ||
| Insomnia n | 13 | 0 |
| Delirium o | 12 | 4 |
| Renal and Urinary Disorders | ||
| Renal insufficiency p | 11 | 2 |
| Respiratory, Thoracic and Mediastinal Disorders | ||
| Cough q | 27 | 1 |
| Hypoxia | 21 | 9 |
| Skin and Subcutaneous Tissue Disorders | ||
| Rash r | 17 | 1 |
| Vascular Disorders | ||
| Hypotension s | 47 | 11 |
| The following events were also counted in the incidence of CRS: coagulopathy, tachycardia, arrhythmia, cardiac failure, diarrhea, nausea, vomiting, fever, fatigue, chills, edema, decreased appetite, musculoskeletal pain, headache, tremor, dizziness, renal insufficiency, cough, hypoxia, dyspnea, pleural effusion, respiratory failure, rash, hypotension, and hypertension. a. Tachycardia includes tachycardia, sinus tachycardia. b. Arrhythmia includes arrhythmia, atrial fibrillation, bradycardia, electrocardiogram QT prolonged, extrasystoles, sinus bradycardia, supraventricular extrasystoles, supraventricular tachycardia, ventricular extrasystoles, ventricular tachycardia. c. Diarrhea includes diarrhea, colitis. d. Abdominal pain includes abdominal pain, abdominal discomfort, abdominal pain lower, abdominal pain upper, dyspepsia. e. Fever includes pyrexia. f. Fatigue includes fatigue, asthenia, malaise. g. Edema includes edema, face edema, fluid overload, generalized edema, hypervolemia, localized edema, edema genital, edema peripheral, periorbital edema, peripheral swelling, pulmonary edema. h. Musculoskeletal pain includes musculoskeletal pain, arthralgia, arthritis, back pain, bone pain, flank pain, groin pain, musculoskeletal chest pain, myalgia, neck pain, non-cardiac chest pain, pain in extremity. i. Motor dysfunction includes muscle contractions involuntary, muscle spasms, muscle twitching, muscular weakness. j. Encephalopathy includes encephalopathy, altered state of consciousness, amnesia, apraxia, bradyphrenia, cognitive disorder, confusional state, depressed level of consciousness, disturbance in attention, dysarthria, dysgraphia, dyspraxia, lethargy, loss of consciousness, memory impairment, mental impairment, mental status changes, metabolic encephalopathy, slow speech, somnolence, toxic encephalopathy. k. Headache includes headache and tension headache. l. Dizziness includes dizziness, dizziness postural, presyncope, syncope, vertigo. m. Neuropathy peripheral includes hypoesthesia, lumbar radiculopathy, neuropathy peripheral, paresthesia, peroneal nerve palsy, sciatica. n. Insomnia includes insomnia and sleep deficit. o. Delirium includes delirium, agitation, delusion, disorientation, hallucination, irritability, restlessness. p. Renal insufficiency includes acute kidney injury, blood creatinine increased, chronic kidney disease. q. Cough includes cough, productive cough, upper-airway cough syndrome. r. Rash includes rash, dermatitis, dermatitis allergic, dermatitis bullous, drug eruption, erythema, pruritus, rash macular, rash maculo-papular, rash pruritic, urticaria. s. Hypotension includes hypotension, capillary leak syndrome, orthostatic hypotension. |
||
Other clinically important adverse reactions that occurred in less than 10% of patients treated with YESCARTA include the following:
Table 4. Grade 3 or 4 Laboratory Abnormalities Occurring in ≥ 10% of Patients in ZUMA-7 Following Treatment with YESCARTA1 (N = 168)
| Laboratory Abnormality | YESCARTA |
| Grades 3 or 4 (%) | |
| Leukocyte decrease | 95 |
| Neutrophil decrease | 94 |
| Lymphocyte decrease | 94 |
| Hemoglobin decrease | 40 |
| Platelet decrease | 26 |
| Sodium decrease | 12 |
| Glucose increase | 11 |
| 1Baseline lab values were assessed prior to lymphodepleting chemotherapy. | |
The safety of YESCARTA was evaluated in ZUMA-1, a study in which 108 patients with relapsed or refractory LBCL received CD19-positive CAR T cells based on a recommended dose which was weight-based [see Clinical Studies]. Patients with a history of CNS disorders (such as seizures or cerebrovascular ischemia) or autoimmune disease requiring systemic immunosuppression were ineligible. The median age of the study population was 58 years (range: 23 to 76 years); 68% were male. The baseline Eastern Cooperative Oncology Group (ECOG) performance status was 0 in 43% of patients and 1 in 57% of patients.
The most common adverse reactions (incidence ≥ 20%) included CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections with pathogen unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias. Serious adverse reactions occurred in 52% of patients. The most common serious adverse reactions (> 2%) included encephalopathy, fever, lung infection, febrile neutropenia, cardiac arrhythmia, cardiac failure, urinary tract infection, renal insufficiency, aphasia, cardiac arrest, Clostridium difficile infection, delirium, hypotension, and hypoxia.
The most common (≥ 10%) Grade 3 or higher reactions included febrile neutropenia, fever, CRS, encephalopathy, infections with pathogen unspecified, hypotension, hypoxia, and lung infections.
Forty-five percent (49/108) of patients received tocilizumab after infusion of YESCARTA.
Table 5 summarizes non-laboratory adverse reactions that occurred in ≥ 10% of patients treated with YESCARTA, and Table 6 describes the laboratory abnormalities of Grade 3 or 4 that occurred in ≥ 10% of patients.
Table 5. Adverse Reactions Observed in ≥ 10% of Patients Treated with YESCARTA in ZUMA-1 (N = 108)
| Adverse Reaction | Any Grade (%) | Grade 3 or Higher (%) |
| Blood and Lymphatic System Disorders | ||
| Febrile neutropenia | 34 | 31 |
| Cardiac Disorders | ||
| Tachycardia a | 57 | 2 |
| Arrhythmia b | 23 | 7 |
| Gastrointestinal Disorders | ||
| Diarrhea | 38 | 4 |
| Nausea | 34 | 0 |
| Vomiting | 26 | 1 |
| Constipation | 23 | 0 |
| Abdominal pain c | 14 | 1 |
| Dry mouth | 11 | 0 |
| General Disorders and Administration Site Conditions | ||
| Fever d | 86 | 16 |
| Fatigue e | 46 | 3 |
| Chills | 40 | 0 |
| Edema f | 19 | 1 |
| Immune System Disorders | ||
| Cytokine release syndrome | 94 | 13 |
| Hypogammaglobulinemia g | 15 | 0 |
| Infections and Infestations | ||
| Infections with pathogen unspecified | 26 | 16 |
| Viral infections | 16 | 4 |
| Bacterial infections | 13 | 9 |
| Investigations | ||
| Decreased appetite | 44 | 2 |
| Weight decreased | 16 | 0 |
| Dehydration | 11 | 3 |
| Musculoskeletal and Connective Tissue Disorders | ||
| Motor dysfunction h | 19 | 1 |
| Pain in extremity i | 17 | 2 |
| Back pain | 15 | 1 |
| Muscle pain | 14 | 1 |
| Arthralgia | 10 | 0 |
| Nervous System Disorders | ||
| Encephalopathy j | 57 | 29 |
| Headache k | 45 | 1 |
| Tremor | 31 | 2 |
| Dizziness l | 21 | 1 |
| Aphasia m | 18 | 6 |
| Psychiatric Disorders | ||
| Delirium n | 17 | 6 |
| Respiratory, Thoracic and Mediastinal Disorders | ||
| Hypoxia o | 32 | 11 |
| Cough p | 30 | 0 |
| Dyspnea q | 19 | 3 |
| Pleural effusion | 13 | 2 |
| Renal and Urinary Disorders | ||
| Renal insufficiency | 12 | 5 |
| Vascular Disorders | ||
| Hypotension r | 57 | 15 |
| Hypertension | 15 | 6 |
| Thrombosis s | 10 | 1 |
| The following events were also counted in the incidence of CRS: tachycardia, arrhythmia, fever, chills, hypoxia, renal insufficiency, and hypotension. a. Tachycardia includes tachycardia, sinus tachycardia. b. Arrhythmia includes arrhythmia, atrial fibrillation, atrial flutter, atrioventricular block, bundle branch block right, electrocardiogram QT prolonged, extra-systoles, heart rate irregular, supraventricular extra systoles, supraventricular tachycardia, ventricular arrhythmia, ventricular tachycardia. c. Abdominal pain includes abdominal pain, abdominal pain lower, abdominal pain upper. d. Fever includes fever, febrile neutropenia. e. Fatigue includes fatigue, malaise. f. Edema includes face edema, generalized edema, local swelling, localized edema, edema, edema genital, edema peripheral, periorbital edema, peripheral swelling, scrotal edema. g. Hypogammaglobulinemia includes hypogammaglobulinemia, blood immunoglobulin D decreased, blood immunoglobulin G decreased. h. Motor dysfunction includes muscle spasms, muscular weakness. i. Pain in extremity includes pain not otherwise specified, pain in extremity. j. Encephalopathy includes cognitive disorder, confusional state, depressed level of consciousness, disturbance in attention, encephalopathy, hypersomnia, leukoencephalopathy, memory impairment, mental status changes, paranoia, somnolence, stupor. k. Headache includes headache, head discomfort, sinus headache, procedural headache. l. Dizziness includes dizziness, presyncope, syncope. m. Aphasia includes aphasia, dysphasia. n. Delirium includes agitation, delirium, delusion, disorientation, hallucination, hyperactivity, irritability, restlessness. o. Hypoxia includes hypoxia, oxygen saturation decreased. p. Cough includes cough, productive cough, upper-airway cough syndrome. q. Dyspnea includes acute respiratory failure, dyspnea, orthopnea, respiratory distress. r. Hypotension includes diastolic hypotension, hypotension, orthostatic hypotension. s. Thrombosis includes deep vein thrombosis, embolism, embolism venous, pulmonary embolism, splenic infarction, splenic vein thrombosis, subclavian vein thrombosis, thrombosis, thrombosis in device. |
||
Other clinically important adverse reactions that occurred in less than 10% of patients treated with YESCARTA include the following:
Table 6. Grade 3 or 4 Laboratory Abnormalities Occurring in ≥ 10% of Patients in ZUMA-1 Following Treatment with YESCARTA1 (N = 108)
| Laboratory Abnormality | Grades 3 or 4 (%) |
| Lymphocyte decrease | 96 |
| Leukocyte decrease | 96 |
| Neutrophil decrease | 92 |
| Hemoglobin decrease | 60 |
| Platelet decrease | 56 |
| Phosphate decrease | 52 |
| Sodium decrease | 19 |
| Albumin decrease | 19 |
| Direct bilirubin increased | 14 |
| Uric acid increased | 13 |
| Potassium decrease | 11 |
| 1 Baseline lab values were assessed prior to lymphodepleting chemotherapy. | |
The safety and efficacy of YESCARTA was evaluated in two subsequent cohorts of LBCL patients. The first subsequent, open label, safety management cohort in ZUMA-1 evaluated the safety and efficacy of YESCARTA with the use of tocilizumab and/or corticosteroid and prophylactic levetiracetam (750 mg PO or IV twice daily) for Grade 1 CRS or neurologic events (see Tables 1 and 2). A total of 46 patients with relapsed or refractory LBCL were enrolled and 41 patients were treated with YESCARTA. Of the remaining 5 patients who were not treated, 2 patients died prior to receiving YESCARTA and 3 patients were ineligible due to disease progression. Twenty-eight patients (68%) treated with YESCARTA received bridging therapy between leukapheresis and lymphodepleting chemotherapy. Thirty-two patients (78%) treated with YESCARTA received tocilizumab and/or corticosteroid for CRS and/or neurologic events. Fifteen of 36 with Grade 1 CRS and 21 of 24 patients with Grade 2 CRS received tocilizumab and/or corticosteroids. Among patients who received treatment for Grade 1 or Grade 2 CRS, most patients (13 of 15 and 19 of 21 patients, respectively) received both tocilizumab and corticosteroids. Most patients received 1 or 2 doses of each drug. Ten of 27 patients with Grade 1 and 7 of 15 patients with Grade 2 neurologic events received corticosteroids alone or in combination with tocilizumab.
The second subsequent, open label, safety management cohort in ZUMA-1 evaluated the safety and efficacy of YESCARTA with the use of prophylactic corticosteroids (oral dexamethasone 10 mg once daily for 3 days, starting prior to YESCARTA infusion on Day 0) and prophylactic levetiracetam (750 mg PO or IV) [see WARNINGS AND PRECAUTIONS].
The safety of YESCARTA was evaluated in ZUMA-5, a study that included 146 patients with relapsed or refractory iNHL (124 patients with FL and 22 with marginal zone lymphoma) who received CD19-positive CAR T cells [see Clinical Studies]. Patients with a history of CNS disorders or autoimmune disease requiring systemic immunosuppression were ineligible. The median age was 61 years (range: 34 to 79 years), 43% were female, 93% were white, 3% were black, and 1% were Asian.
The most common non-laboratory adverse reactions (incidence ≥ 20%) included fever, CRS, hypotension, encephalopathy, fatigue, headache, infections with pathogen unspecified, tachycardia, febrile neutropenia, musculoskeletal pain, nausea, tremor, chills, diarrhea, constipation, decreased appetite, cough, vomiting, hypoxia, arrhythmia, and dizziness. Serious adverse reactions occurred in 48% of patients. Serious adverse reactions in > 2% of patients included febrile neutropenia, encephalopathy, fever, CRS, infections with pathogen unspecified, pneumonia, hypoxia, and hypotension.
The most common (≥ 10%) Grade 3 or higher reactions included febrile neutropenia, encephalopathy, and infections with pathogen unspecified. Fatal adverse reactions occurred in 1% of patients and included CRS and fungal infection.
Fifty-one percent (75/146) of patients received tocilizumab after infusion of YESCARTA.
Table 7 summarizes the adverse reactions, excluding laboratory terms, that occurred in at least 10% of patients treated with YESCARTA and Table 8 describes Grade 3 or 4 laboratory abnormalities that developed or worsened in at least 10% of patients.
Table 7. Adverse Reactions in ≥ 10% of Patients Treated with YESCARTA in ZUMA-5 (N = 146)
| Adverse Reaction | Any Grade (%) | Grade 3 or Higher (%) |
| Blood and lymphatic system disorders | ||
| Febrile neutropenia a | 41 | 41 |
| Cardiac Disorders | ||
| Tachycardia b | 44 | 1 |
| Arrhythmia c | 21 | 2 |
| Gastrointestinal Disorders | ||
| Nausea | 40 | 0 |
| Diarrhea d | 29 | 1 |
| Constipation | 28 | 0 |
| Vomiting | 24 | 1 |
| Abdominal pain e | 16 | 0 |
| General Disorders and Administration Site Conditions | ||
| Fever | 85 | 8 |
| Fatigue f | 49 | 1 |
| Chills | 29 | 0 |
| Edema g | 13 | 1 |
| Immune System Disorders | ||
| Cytokine release syndrome | 84 | 8 |
| Immunoglobulins decreased h | 18 | 1 |
| Infections and Infestations | ||
| Infections with pathogen unspecified | 45 | 14 |
| Pneumonia i | 13 | 8 |
| Fungal infections | 12 | 2 |
| Viral Infections | 13 | 2 |
| Metabolism and Nutrition Disorders | ||
| Decreased appetite j | 26 | 1 |
| Musculoskeletal and Connective Tissue Disorders | ||
| Musculoskeletal pain k | 40 | 1 |
| Motor dysfunction l | 18 | 2 |
| Nervous System Disorders | ||
| Encephalopathy m | 49 | 16 |
| Headache | 45 | 1 |
| Tremor | 31 | 1 |
| Dizziness n | 20 | 0 |
| Aphasia | 14 | 4 |
| Neuropathy peripheral o | 12 | 0 |
| Ataxia p | 10 | 0 |
| Psychiatric Disorders | ||
| Delirium q | 16 | 5 |
| Insomnia | 16 | 0 |
| Affective disorder r | 10 | 1 |
| Respiratory, Thoracic and Mediastinal Disorders | ||
| Cough s | 25 | 0 |
| Hypoxia | 23 | 8 |
| Dyspnea t | 12 | 1 |
| Nasal congestion | 10 | 0 |
| Skin and Subcutaneous Tissue Disorders | ||
| Rash u | 19 | 3 |
| Vascular Disorders | ||
| Hypotension v | 51 | 4 |
| Hypertension | 13 | 6 |
| Thrombosis w | 12 | 4 |
| a. Febrile neutropenia includes febrile neutropenia, fever overlapping with neutropenia. b. Tachycardia includes tachycardia, sinus tachycardia. c. Arrhythmia includes atrial fibrillation, atrioventricular block first degree, bradycardia, sinus bradycardia, supraventricular tachycardia, ventricular arrhythmia, ventricular extra systoles, ventricular tachycardia, electrocardiogram QT prolonged, electrocardiogram T wave inversion. d. Diarrhea includes diarrhea, colitis, enteritis. e. Abdominal pain includes abdominal pain, abdominal discomfort, abdominal pain lower, abdominal pain upper, abdominal tenderness, dyspepsia, epigastric discomfort. f. Fatigue includes asthenia, fatigue, decreased activity, malaise. g. Edema includes edema, face edema, generalized edema, localized edema, edema peripheral, peripheral swelling, pulmonary edema, swelling face. h. Immunoglobulins decreased includes hypogammaglobulinemia, blood immunoglobulin G decreased. i. Pneumonia includes pneumonia streptococcal, pneumonia, lung infiltration. Pneumonia is also summarized under infections with pathogen unspecified. j. Decreased appetite includes decreased appetite, hypophagia. k. Musculoskeletal pain includes musculoskeletal pain, arthralgia, back pain, bone pain, flank pain, groin pain, musculoskeletal chest pain, myalgia, neck pain, osteoarthritis, pain in extremity. l. Motor dysfunction includes motor dysfunction, muscle rigidity, muscle spasms, muscle strain, muscular weakness. m. Encephalopathy includes agraphia, amnesia, aphonia, apraxia, CAR T-cell-related encephalopathy syndrome, cognitive disorder, disturbance in attention, dysarthria, dysgraphia, dyskinesia, encephalopathy, lethargy, loss of consciousness, memory impairment, somnolence, speech disorder, confusional state, mental status changes, immune effector cell-associated neurotoxicity, neurotoxicity, toxic encephalopathy. n. Dizziness includes dizziness, presyncope, syncope, vertigo. o. Neuropathy peripheral includes allodynia, cervical radiculopathy, hyperesthesia, hypoesthesia, neuralgia, neuropathy peripheral, paresthesia, peripheral sensory neuropathy. p. Ataxia includes ataxia, balance disorder, gait disturbance, vestibular disorder. q. Delirium includes agitation, delirium, hallucination, restlessness. r. Affective disorder includes anxiety, depression, impulsive behavior, mania, panic attack. s. Cough includes cough, productive cough, upper-airway cough syndrome. t. Dyspnea includes dyspnea, dyspnea exertional. u. Rash includes dermatitis bullous, erythema, pruritus, rash, rash macular, rash maculo-papular, Stevens-Johnson syndrome, urticaria. v. Hypotension includes capillary leak syndrome, hypotension, hypoperfusion, orthostatic hypotension. w. Thrombosis includes deep vein thrombosis, embolism, peripheral ischemia, pulmonary embolism, thrombosis in device, vascular occlusion, jugular vein thrombosis. |
||
Other clinically important adverse reactions that occurred in less than 10% of patients treated with YESCARTA include the following:
Table 8. Grade 3 or 4 Laboratory Abnormalities Occurring in ≥ 10% of Patients in ZUMA-5 Following Treatment with YESCARTA1 (N = 146)
| Laboratory Abnormality | Grades 3 or 4 (%) |
| Lymphocyte decrease | 96 |
| Leukocyte decrease | 94 |
| Neutrophil decrease | 92 |
| Platelet decrease | 35 |
| Hemoglobin decrease | 32 |
| Phosphate decrease | 25 |
| Sodium decrease | 10 |
| Glucose increase | 10 |
| Calcium decrease | 10 |
| 1 Baseline lab values were assessed prior to lymphodepleting chemotherapy. | |
YESCARTA has the potential to induce anti-product antibodies. The immunogenicity of YESCARTA has been evaluated using an enzyme-linked immunosorbent assay (ELISA) for the detection of binding antibodies against FMC63, the originating antibody of the anti-CD19 CAR. Eleven patients (4%) tested positive for pre-dose anti-FMC63 antibodies at baseline in ZUMA-7 and ZUMA-1, and one patient (1%) who had a negative test result at baseline had a positive test result post administration of YESCARTA in the screening ELISA in ZUMA-7. In ZUMA-5, 19 patients (13%) were antibody-positive at baseline, and 3 patients (2%) who had negative test results at baseline had positive test results post administration of YESCARTA in the screening ELISA. Results of a confirmatory cell-based assay, leveraging a properly folded and expressed extracellular portion of the CAR (ScFv, hinge and linker) demonstrated that all patients treated with YESCARTA that had a positive result in the screening ELISA were antibody negative at all time points tested. There is no evidence that the kinetics of initial expansion and persistence of YESCARTA, or the safety or effectiveness of YESCARTA, was altered in these patients.
Because adverse events to marketed products are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to product exposure.
The following adverse event has been identified during postmarketing use of YESCARTA.
Spinal cord edema, myelitis, quadriplegia, dysphagia, and status epilepticus.
Infusion related reactions
T cell malignancies
No Information Provided
Included as part of the PRECAUTIONS section.
CRS, including fatal or life-threatening reactions, occurred following treatment with YESCARTA. CRS occurred in 90% (379/422) of patients with non-Hodgkin lymphoma (NHL) receiving YESCARTA, including ≥ Grade 3 (Lee grading system1) CRS in 9%. CRS occurred in 93% (256/276) of patients with large B-cell lymphoma (LBCL), including ≥ Grade 3 CRS in 9% [see Adverse Reactions (6)]. Among patients with LBCL who died after receiving YESCARTA, four had ongoing CRS events at the time of death. For patients with LBCL in ZUMA-1, the median time to onset of CRS was 2 days following infusion (range: 1 to 12 days) and the median duration of CRS was 7 days (range: 2 to 58 days). For patients with LBCL in ZUMA-7, the median time to onset of CRS was 3 days following infusion (range: 1 to 10 days) and the median duration was 7 days (range: 2 to 43 days).
CRS occurred in 84% (123/146) of patients with indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5, including ≥ Grade 3 CRS in 8% [see Adverse Reactions (6)]. Among patients with iNHL who died after receiving YESCARTA, one patient had an ongoing CRS event at the time of death. The median time to onset of CRS was 4 days (range: 1 to 20 days) and the median duration was 6 days (range: 1 to 27 days) for patients with iNHL.
Key manifestations of CRS (≥ 10%) in all patients combined included fever (85%), hypotension (40%), tachycardia (32%), chills (22%), hypoxia (20%), headache (15%), and fatigue (12%). Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), renal insufficiency, cardiac failure, respiratory failure, cardiac arrest, capillary leak syndrome, multi-organ failure, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) [see Adverse Reactions (6)].
The impact of tocilizumab and/or corticosteroids on the incidence and severity of CRS was assessed in two subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received tocilizumab and/or corticosteroids for ongoing Grade 1 events (see Table 1) [see Clinical Trials Experience (6.1)], CRS occurred in 93% (38/41), including 2% (1/41) with Grade 3 CRS; no patients experienced a Grade 4 or 5 event. The median time to onset of CRS was 2 days (range: 1 to 8 days) and the median duration of CRS was 7 days (range: 2 to 16 days).
Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA [see Clinical Trials Experience (6.1)]. Thirty-one of the 39 patients (79%) developed CRS at which point the patients were managed with tocilizumab and/or therapeutic doses of corticosteroids with no patients developing Grade 3 or higher CRS. The median time to onset of CRS was 5 days (range: 1 to 15 days) and the median duration of CRS was 4 days (range: 1 to 10 days). Although there is no known mechanistic explanation, consider the risk and benefits of prophylactic corticosteroids in the context of pre-existing comorbidities for the individual patient and the potential for the risk of Grade 4 and prolonged neurologic toxicities [See Neurologic Toxicities (5.2)].
Confirm that 2 doses of tocilizumab are available prior to infusion of YESCARTA. Monitor patients at least daily for 7 days following infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for 2 weeks after infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time [see Patient Counseling Information (17)]. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated [see Dosage and Administration (2.3)].
Neurologic toxicities (including ICANS) that were fatal or life-threatening occurred following treatment with YESCARTA. Neurologic toxicities occurred in 78% (330/422) of patients with NHL receiving YESCARTA, including ≥ Grade 3 cases in 25%.
Neurologic toxicities occurred in 87% (94/108) of patients with LBCL in ZUMA-1, including ≥ Grade 3 cases in 31% and in 74% (124/168) of patients in ZUMA-7 including ≥ Grade 3 cases in 25%. The median time to onset was 4 days (range: 1 to 43 days) and the median duration was 17 days in patients with LBCL in ZUMA-1. The median time to onset for neurologic toxicity was 5 days (range:1 to 133 days) and median duration was 15 days in patients with LBCL in ZUMA-7. Neurologic toxicities occurred in 77% (112/146) of patients with iNHL, including ≥ Grade 3 in 21%. The median time to onset was 6 days (range: 1 to 79 days) and the median duration was 16 days. Ninety-eight percent of all neurologic toxicities in patients with LBCL and 99% of all neurologic toxicities in patients with iNHL occurred within the first 8 weeks of YESCARTA infusion. Neurologic toxicities occurred within the first 7 days of YESCARTA infusion in 87% of affected patients with LBCL and 74% of affected patients with iNHL.
The most common neurologic toxicities (≥ 10%) in all patients combined included encephalopathy (50%), headache (43%), tremor (29%), dizziness (21%), aphasia (17%), delirium (15%), and insomnia (10%). Prolonged encephalopathy lasting up to 173 days was noted. Serious events including aphasia, leukoencephalopathy, dysarthria, lethargy, and seizures occurred with YESCARTA. Fatal and serious cases of cerebral edema and encephalopathy, including late-onset encephalopathy, have occurred in patients treated with YESCARTA.
The impact of tocilizumab and/or corticosteroids on the incidence and severity of neurologic toxicities was assessed in two subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received corticosteroids at the onset of Grade 1 toxicities (see Table 2), neurologic toxicities occurred in 78% (32/41) and 20% (8/41) had Grade 3 neurologic toxicities; no patients experienced a Grade 4 or 5 event. The median time to onset of neurologic toxicities was 6 days (range: 1 to 93 days) with a median duration of 8 days (range: 1 to 144 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA [see Clinical Trials Experience (6.1)]. Of these 39 patients, 85% (33/39) developed neurologic toxicities; 8% (3/39) developed Grade 3 and 5% (2/39) developed Grade 4 neurologic toxicities. The median time to onset of neurological toxicities was 6 days (range: 1 to 274 days) with a median duration of 12 days (range: 1 to 107 days). Prophylactic corticosteroids for management of CRS and neurologic toxicities may result in higher grade of neurologic toxicities or prolongation of neurologic toxicities, delay the onset and decrease the duration of CRS [See Cytokine Release Syndrome (5.1)] .
Monitor patients at least daily for 7 days following infusion for signs and symptoms of neurologic toxicities. Monitor patients for signs or symptoms of neurologic toxicities for 2 weeks after infusion and treat promptly [see Dosage and Administration (2.3)] . Advise patients to avoid driving for at least 2 weeks following infusion.
Allergic reactions may occur with the infusion of YESCARTA. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) or residual gentamicin in YESCARTA.
Severe or life-threatening infections occurred in patients after YESCARTA infusion. Infections (all grades) occurred in 45% of patients with NHL. Grade 3 or higher infections occurred in 17% of patients, including Grade 3 or higher infections with an unspecified pathogen in 12%, bacterial infections in 5%, viral infections in 3%, and fungal infections in 1%. YESCARTA should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after YESCARTA infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines.
Febrile neutropenia was observed in 36% of patients with NHL after YESCARTA infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated.
In immunosuppressed patients, including those who have received YESCARTA, life-threatening and fatal opportunistic infections including disseminated fungal infections (e.g., candida sepsis and aspergillus infections) and viral reactivation (e.g., human herpes virus-6 [HHV-6] encephalitis and JC virus progressive multifocal leukoencephalopathy [PML]) have been reported. The possibility of HHV-6 encephalitis and PML should be considered in immunosuppressed patients with neurologic events and appropriate diagnostic evaluations should be performed.
Hepatitis B Virus ReactivationHepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, has occurred in patients treated with drugs directed against B cells, including YESCARTA. Perform screening for HBV, HCV, and HIV and management in accordance with clinical guidelines before collection of cells for manufacturing.
Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion. Grade 3 or higher cytopenias not resolved by Day 30 following YESCARTA infusion occurred in 39% of all patients with NHL and included neutropenia (33%), thrombocytopenia (13%), and anemia (8%). Monitor blood counts after YESCARTA infusion.
B-cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with YESCARTA. Hypogammaglobulinemia was reported as an adverse reaction in 14% of all patients with NHL. Monitor immunoglobulin levels after treatment with YESCARTA and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement.
The safety of immunization with live viral vaccines during or following YESCARTA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during YESCARTA treatment, and until immune recovery following treatment with YESCARTA.
Patients treated with YESCARTA may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including YESCARTA. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes [see Boxed Warning, Adverse Reactions (6.3), Patient Counseling Information (17)] .
Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Kite at 1-844- 454-KITE (5483) to obtain instructions on patient samples to collect for testing.
No carcinogenicity or genotoxicity studies have been conducted with YESCARTA. No studies have been conducted to evaluate the effects of YESCARTA on fertility.
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Ensure that patients understand the risk of manufacturing failure (< 1% in clinical trials). In case of a manufacturing failure, a second manufacturing of YESCARTA may be attempted. In addition, while the patient awaits the product, additional chemotherapy (not the lymphodepletion) may be necessary and may increase the risk of adverse events during the pre-infusion period.
Advise patients to seek immediate attention for any of the following:
Advise patients of the need to:
Manufactured by, Packed by, Distributed by:
Kite Pharma, Inc.
Santa Monica, CA 90404
US License No 2064
YESCARTA is a trademark of Kite Pharma, Inc. All other trademarks referenced herein are the property of their respective owners.
© 2025 Kite Pharma, Inc. All Rights Reserved.
125643-GS-014
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No information provided.
YESCARTA, a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells. Studies demonstrated that following anti-CD19 CAR T cell engagement with CD19-expressing target cells, the CD28 and CD3-zeta co-stimulatory domains activate downstream signaling cascades that lead to T cell activation, proliferation, acquisition of effector functions and secretion of inflammatory cytokines and chemokines. This sequence of events leads to killing of CD19-expressing cells.
After YESCARTA infusion, pharmacodynamic responses were evaluated over a 4-week interval by measuring transient elevation of cytokines, chemokines and other molecules in blood. Levels of cytokines and chemokines such as IL-6, IL-8, IL-10, IL-15, TNF-α, IFN-γ, and sIL2Rα were analyzed. Peak elevation was observed within the first 14 days after infusion, and levels generally returned to baseline within 28 days.
Due to the on-target effect of YESCARTA, a period of B-cell aplasia is expected.
Large B-cell lymphoma
Among patients with LBCL with an ongoing response at 24 months in the ZUMA-7 study, 21 of 61 evaluable patients (34%) had no detectable B cells at baseline, and the majority of patients at Month 3 (43 of 69 evaluable patients [62%]) and Month 6 (8 of 13 evaluable patients [62%]) had no detectable B cells. At Month 24, 20 of 24 evaluable patients (83%) had detectable B cells.
Among patients with LBCL with an ongoing response at 24 months in the ZUMA-1 study, 13 of 29 evaluable patients (45%) had no detectable B cells at baseline, and the majority of patients at Month 3 (28 of 35 evaluable patients [80%]) and Month 6 (25 of 32 evaluable patients [78%]) had no detectable B cells. At Month 24, 24 of 32 evaluable patients (75%) had detectable B cells.
Following infusion of YESCARTA, anti-CD19 CAR T cells exhibited an initial rapid expansion followed by a decline to near baseline levels by 3 months. Peak levels of anti-CD19 CAR T cells occurred within the first 7 - 14 days after YESCARTA infusion.
Age (range: 21 to 80 years) and gender had no significant impact on AUC Day 0 - 28 and Cmax of YESCARTA.
Large B-cell Lymphoma
Among patients with LBCL in the ZUMA-1 study (n=96 evaluable), the number of anti-CD19 CAR T cells in blood was positively associated with objective response (CR or PR). The median anti-CD19 CAR T cell Cmax levels in responders (n=73) were 205% higher compared to the corresponding level in nonresponders (n=23) (43.6 cells/μL vs 21.2 cells/μL). Median AUC Day 0 - 28 in responding patients (n=73) was 251% of the corresponding level in nonresponders (n=23) (557.1 days × cells/μL vs. 222.0 days × cells/μL).
Among patients with LBCL in the ZUMA-7 study (n=162 evaluable), the number of anti-CD19 CAR T cells in blood was positively associated with objective response [complete remission (CR) or partial remission (PR)]. The median anti-CD19 CAR T cell Cmax levels in responders (n=142) were 275% higher compared to the corresponding level in nonresponders (n=20) (28.9 cells/μL vs 10.5 cells/μL). Median AUC Day 0 - 28 in responding patients (n=142) was 418% of the corresponding level in nonresponders (n=20) (292.9 days × cells/μL vs. 70.1 days × cells/μL). No association between peak anti-CD19 CAR T-cell levels and OS was observed among 163 subjects with an evaluable pharmacokinetic sample when anti-CD19 CAR T-cell peaks were categorized as > median relative to ≤ median.
Follicular Lymphoma
Among patients with FL in the ZUMA-5 study (n=81 evaluable), the median anti-CD19 CAR T cell Cmax levels in responders (n=74) were 40.1 cells/μL and 46.0 cells/μL in nonresponders (n=7). The median AUC Day 0 - 28 in responding FL patients (n=74) were 465.8 days × cells/μL and 404.5 days × cells/μL in nonresponders (n=7).
Some patients required tocilizumab and corticosteroids for management of CRS and neurologic toxicities. Patients treated with tocilizumab (n=44) had 262% and 232% higher anti-CD19 CAR T cells as measured by AUC Day 0 - 28 and Cmax respectively, as compared to patients who did not receive tocilizumab (n=57). Similarly, patients that received corticosteroids (n=26) had 217% and 155% higher AUC Day 0 - 28 and Cmax compared to patients who did not receive corticosteroids (n=75).
Hepatic and renal impairment studies of YESCARTA were not conducted.
MEDICATION GUIDE
YESCARTA (pronounced yes-kar-ta)
(axicabtagene ciloleucel)
Read this Medication Guide before you start your YESCARTA treatment. The more you know about your treatment, the more active you can be in your care. Talk with your healthcare provider if you have questions about your health condition or treatment. Reading this Medication Guide does not take the place of talking with your healthcare provider about your treatment.
What is the most important information I should know about YESCARTA?
YESCARTA may cause side effects that are life-threatening and can lead to death. Call or see your healthcare provider or get emergency help right away if you get any of the following:
It is important to tell your healthcare provider that you received YESCARTA and to show them your YESCARTA Patient Wallet Card. Your healthcare provider may give you other medicines to treat your side effects.
What is YESCARTA?
YESCARTA is a prescription medicine used to treat two types of non-Hodgkin lymphoma:
YESCARTA is different than other cancer medicines because it is made from your own white blood cells, which have been modified to recognize and attack your lymphoma cells.
Before getting YESCARTA, tell your healthcare provider about all your medical problems, including if you have or have had:
Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive YESCARTA?
What should I avoid after receiving YESCARTA?
What are the possible or reasonably likely side effects of YESCARTA?
The most common side effects of YESCARTA include:
YESCARTA may increase your risk of getting cancers including certain types of blood cancers. Your healthcare provider should monitor you for this.
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.
General information about the safe and effective use of YESCARTA
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information about YESCARTA, talk with your healthcare provider. You can ask your healthcare provider for information about YESCARTA that is written for health professionals. You can get additional information by contacting Kite at 1-844-454-KITE (5483) or at www.Yescarta.com.
What are the ingredients in YESCARTA?
Active ingredients: axicabtagene ciloleucel.
Inactive ingredients: albumin (human); DMSO.
YESCARTA is a trademark of Kite Pharma, Inc. All other trademarks referenced herein are the property of their respective owners.
© 2025 Kite Pharma, Inc. All Rights Reserved.
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: June 2025
