SUPPORT AND RESOURCES

FROM INSURANCE COVERAGE TO PATIENT SUPPORT, THERE IS A VARIETY OF RESOURCE INFORMATION AVAILABLE

KITE KONNECT®: A RESOURCE THROUGHOUT THE TREATMENT PROCESS

Kite Konnect® is committed to helping patients and providing information to their healthcare team throughout the YESCARTA® process.

Kite Konnect: Get your patient started by finding a YESCARTA Authorized Treatment Center.

Connect Patients to an Oncologist With YESCARTA Experience

Providing patients and healthcare professionals information on Authorized Treatment Centers.

Kite Konnect: Providing information about potential options for transportation and housing assistance.

Logistics Support

Providing information about potential options for transportation and housing assistance.

Kite Konnect: Help with benefits investigations, claims appeals information, and potential sources of support for eligible and underinsured patients.

Reimbursement Support

Help with benefits investigations, claims appeals information, and potential sources of support for eligible and underinsured patients.

Kite Konnect: Kite Konnect Case Managers are available to support you and your patients throughout treatment.

Ongoing Commitment

Kite Konnect® Case Managers are available to support you and your patient throughout the CAR T treatment journey.

SUPPORTING BOTH SIDES OF CARE

Refer for YESCARTA if you've identified a potentially eligible patient. Refer for YESCARTA if you've identified a potentially eligible patient.

Primary
hematologist/oncologist

If you’ve identified a patient who is potentially eligible for YESCARTA, find a YESCARTA Authorized Treatment Center for early consult, evaluation, and preparation. You can also call Kite Konnect® at 1-844-454-KITE (5483).

Enroll a patient for leukapheresis at an Authorized Treatment Center. Enroll a patient for leukapheresis at an Authorized Treatment Center.

Authorized Treatment Center physician

If you are ready to enroll a patient for YESCARTA, access the Hospital Portal with your login credentials. If you do not have your login information, please call 1-844-454-KITE (5483).

VVisit Kite Konnect, your resource throughout the treatment process.

Collaborative Care With Kite Konnect®

You are at the center of your patients’ treatment journey, and Kite Konnect is here to help.

Visit KiteKonnect.com

Or call Kite Konnect® at 1-844-454-KITE (5483)

RESOURCES

Kite is committed to providing information and support to patients and healthcare providers at every step of the treatment process. See the following resources available for download and be sure to check back often for new materials.

Frequently Asked Questions

CAR T TECHNOLOGY
  • What is CAR T therapy?
  • Chimeric antigen receptor T-cell therapy engineers a patient’s T cells to express a chimeric antigen receptor. This receptor allows the engineered T cells to identify, bind, and eliminate cells expressing the target antigen.1

    Learn more about the technology behind YESCARTA.

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  • What makes up the YESCARTA chimeric antigen receptor?
  • A chimeric antigen receptor has 3 domains: a target-binding domain, a costimulatory domain, and an activation domain. Because YESCARTA targets CD19, the target-binding domain is anti-CD19, designed to identify and bind to the CD19 antigen on the surface of cancerous and normal B cells. The costimulatory domain of YESCARTA is CD28, which along with the CD3-zeta activation domain, helps activate the CAR T cell upon binding to CD19. CAR T-cell activation allows the release of inflammatory cytokines and chemokines that lead to the elimination of target B cells.1

    Learn more about the technology behind YESCARTA.

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  • How is YESCARTA made?
  • YESCARTA is made by first collecting lymphocytes from the patient (leukapheresis). The patient’s T cells are then isolated and engineered ex vivo at a state-of-the-art Kite facility to become CAR T cells (cell manufacturing). In the ZUMA-5 pivotal trial, Kite demonstrated a 17-day median turnaround time and 100% success rate in manufacturing CAR T cells.1

    Learn more about the manufacturing process of YESCARTA.

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ELIGIBILITY
  • At what point in treatment is YESCARTA an option?
  • It’s important to know when to consider YESCARTA. YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after 2 lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Once a patient has relapsed and/or is refractory to 2 lines of systemic therapy, they are potentially eligible for YESCARTA.1

    Information is not inclusive of all eligibility criteria.


    See what types of patients are potentially eligible for YESCARTA.

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  • Are older patients candidates for YESCARTA?
  • The age of patients with FL who were treated in the ZUMA-5 pivotal trial ranged from 34 to 79 years with a median of 62 years (n=81).1

    GERIATRIC USE: Clinical trials of YESCARTA did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently or have different safety outcomes as compared with younger patients.1


    See what types of patients are potentially eligible for YESCARTA.

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ZUMA-5 PIVOTAL TRIAL DESIGN
  • How was the ZUMA-5 pivotal trial designed?
  • YESCARTA was studied in a phase 2, multicenter, single-arm, open-label study evaluating the efficacy and safety of YESCARTA in adults with r/r FL after 2 lines of therapy1,2:

    • 146 patients received YESCARTA and were evaluated for safety
      • 81 patients with FL were evaluated for efficacy
    • Patients received lymphodepleting chemotherapy: 500 mg/m2 intravenous (IV) cyclophosphamide and 30 mg/m2 IV fludarabine (–5, –4, and –3 days before infusion)
    • YESCARTA was administered as a single infusion to a target dose of 2 x 106 viable CAR T cells/kg body weight
    • Primary endpoint: ORR (CR + PR)
    • Median age: 62 years (range: 34 to 79 years)

    CR=complete remission; FL=follicular lymphoma; ORR=objective response rate; PR=partial remission; r/r=relapsed/refractory.


    Learn more about the design and data of the ZUMA-5 pivotal trial.

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  • What types of patients were studied?
  • ZUMA-5 spanned a range of patients (median age: 62 years, range: 34 to 79 years) with r/r FL, including those with high-risk characteristics (n=81)1:

    • 31% received prior PI3K inhibitor
    • 72% were refractory*
    • 56% had disease progression within 24 months of initiating first anti-CD20 combination therapy

    FL=follicular lymphoma; PI3K=phosphoinositide 3-kinase; r/r=relapsed/refractory.

    *Defined as progression of disease within 6 months of most recent regimen.


    Learn more about the design and data of the ZUMA-5 pivotal trial.

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  • What was the manufacturing success rate for Kite in the ZUMA-5 pivotal trial?
  • In the ZUMA-5 pivotal trial, Kite demonstrated a 17-day median turnaround time1†‡ and 100% success rate in manufacturing CAR T cells.1

    Data reflect results from the ZUMA-5 pivotal trial.

    The median time from leukapheresis to product delivery.


    Learn more about the manufacturing process of YESCARTA.

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ZUMA-5 EFFICACY
  • What was the objective response rate? Complete remission rate? Partial remission rate?
  • In patients with r/r FL, YESCARTA achieved an objective response rate of 91%, a complete remission rate of 60%, and a partial remission rate of 31%.1

    FL=follicular lymphoma; r/r=relapsed/refractory.

    ZUMA-5 STUDY DESIGN1,2

    • ZUMA-5: A phase 2, multicenter, single-arm, open-label study evaluating the efficacy and safety of YESCARTA in adults with r/r follicular lymphoma (FL) after 2 lines of therapy
    • 146 patients received YESCARTA and were evaluated for safety
      • 81 patients with FL were evaluated for efficacy
    • Patients received lymphodepleting chemotherapy: 500 mg/m2 intravenous (IV) cyclophosphamide and 30 mg/m2 IV fludarabine (–5, –4, and –3 days before infusion)
    • YESCARTA was administered as a single infusion to a target dose of 2 x 106 viable CAR T cells/kg body weight
    • Primary endpoint: ORR (CR + PR)
    • Median age: 62 years (range: 34 to 79 years)
    Learn more about the efficacy data from the ZUMA-5 pivotal trial.

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  • What was the duration of response?
  • The median duration of response was not estimable at a 14.5-month median follow-up for DOR (n=74).1

    ZUMA-5 STUDY DESIGN1,2

    • ZUMA-5: A phase 2, multicenter, single-arm, open-label study evaluating the efficacy and safety of YESCARTA in adults with r/r follicular lymphoma (FL) after 2 lines of therapy
    • 146 patients received YESCARTA and were evaluated for safety
      • 81 patients with FL were evaluated for efficacy
    • Patients received lymphodepleting chemotherapy: 500 mg/m2 intravenous (IV) cyclophosphamide and 30 mg/m2 IV fludarabine (–5, –4, and –3 days before infusion)
    • YESCARTA was administered as a single infusion to a target dose of 2 x 106 viable CAR T cells/kg body weight
    • Primary endpoint: ORR (CR + PR)
    • Median age: 62 years (range: 34 to 79 years)
    Learn more about the efficacy data from the ZUMA-5 pivotal trial.

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ZUMA-5 SAFETY
  • What was the overall incidence of cytokine release syndrome (CRS)? What was the incidence of Grade 3 CRS?
  • CRS occurred in 84% (123/146) of patients, including Grade 3 CRS in 8% (11/146) of patients. The median time to onset was 4 days (range: 1 to 20 days) and the median duration of CRS was 6 days (range: 1 to 27 days).1

    Most CRS events in ZUMA-5 occurred early, were generally reversible, and were managed per established guidance.1,3

    ZUMA-5 STUDY DESIGN1,2

    • ZUMA-5: A phase 2, multicenter, single-arm, open-label study evaluating the efficacy and safety of YESCARTA in adults with r/r follicular lymphoma (FL) after 2 lines of therapy
    • 146 patients received YESCARTA and were evaluated for safety
      • 81 patients with FL were evaluated for efficacy
    • Patients received lymphodepleting chemotherapy: 500 mg/m2 intravenous (IV) cyclophosphamide and 30 mg/m2 IV fludarabine (–5, –4, and –3 days before infusion)
    • YESCARTA was administered as a single infusion to a target dose of 2 x 106 viable CAR T cells/kg body weight
    • Primary endpoint: ORR (CR + PR)
    • Median age: 62 years (range: 34 to 79 years)
    Learn more about the safety profile from the ZUMA-5 pivotal trial.

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  • What was the overall incidence of neurologic toxicities? What was the incidence of Grade 3 neurologic toxicities?
  • Neurologic toxicities occurred in 77% (112/146) of patients, 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.1

    Most neurological events in ZUMA-5 occurred early, were generally reversible, and were managed per established guidance.1,3

    ZUMA-5 STUDY DESIGN1,2

    • ZUMA-5: A phase 2, multicenter, single-arm, open-label study evaluating the efficacy and safety of YESCARTA in adults with r/r follicular lymphoma (FL) after 2 lines of therapy
    • 146 patients received YESCARTA and were evaluated for safety
      • 81 patients with FL were evaluated for efficacy
    • Patients received lymphodepleting chemotherapy: 500 mg/m2 intravenous (IV) cyclophosphamide and 30 mg/m2 IV fludarabine (–5, –4, and –3 days before infusion)
    • YESCARTA was administered as a single infusion to a target dose of 2 x 106 viable CAR T cells/kg body weight
    • Primary endpoint: ORR (CR + PR)
    • Median age: 62 years (range: 34 to 79 years)
    Learn more about the safety profile from the ZUMA-5 pivotal trial.

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  • What were the most common adverse reactions? What percentage of patients experienced serious adverse reactions?
  • 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.1

    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.1

    ZUMA-5 STUDY DESIGN1,2

    • ZUMA-5: A phase 2, multicenter, single-arm, open-label study evaluating the efficacy and safety of YESCARTA in adults with r/r follicular lymphoma (FL) after 2 lines of therapy
    • 146 patients received YESCARTA and were evaluated for safety
      • 81 patients with FL were evaluated for efficacy
    • Patients received lymphodepleting chemotherapy: 500 mg/m2 intravenous (IV) cyclophosphamide and 30 mg/m2 IV fludarabine (–5, –4, and –3 days before infusion)
    • YESCARTA was administered as a single infusion to a target dose of 2 x 106 viable CAR T cells/kg body weight
    • Primary endpoint: ORR (CR + PR)
    • Median age: 62 years (range: 34 to 79 years)
    Learn more about the safety profile from the ZUMA-5 pivotal trial.

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  • What were the most common Grade 3 reactions?
  • 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.1

    ZUMA-5 STUDY DESIGN1,2

    • ZUMA-5: A phase 2, multicenter, single-arm, open-label study evaluating the efficacy and safety of YESCARTA in adults with r/r follicular lymphoma (FL) after 2 lines of therapy
    • 146 patients received YESCARTA and were evaluated for safety
      • 81 patients with FL were evaluated for efficacy
    • Patients received lymphodepleting chemotherapy: 500 mg/m2 intravenous (IV) cyclophosphamide and 30 mg/m2 IV fludarabine (–5, –4, and –3 days before infusion)
    • YESCARTA was administered as a single infusion to a target dose of 2 x 106 viable CAR T cells/kg body weight
    • Primary endpoint: ORR (CR + PR)
    • Median age: 62 years (range: 34 to 79 years)
    Learn more about the safety profile from the ZUMA-5 pivotal trial.

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TREATMENT PROCESS

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  • How long does cell manufacturing take?
  • Cell manufacturing takes place after the patient’s T cells are isolated. The ex vivo engineering at a state-of-the-art Kite facility to become CAR T cells takes a median of 17 days (from leukapheresis to product delivery).

    §Data reflect results from the ZUMA-5 pivotal trial.


    Learn more about the YESCARTA treatment process.

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  • What is lymphodepleting chemotherapy?
  • Lymphodepleting chemotherapy is a low-dose chemotherapy regimen that prepares the body to receive YESCARTA. It takes place over 3 days (starting 5 days before YESCARTA infusion) at the Authorized Treatment Center. In the ZUMA-5 pivotal trial, patients received 500 mg/m2 intravenous (IV) cyclophosphamide and 30 mg/m2 IV fludarabine (–5, –4, and –3 days before infusion).1

    Learn more about the YESCARTA treatment process.

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  • What is the target dose of YESCARTA infusion? How long does infusion take?
  • In the ZUMA-5 pivotal trial, YESCARTA was administered as a single infusion to a target dose of 2 x 106 viable CAR T cells/kg body weight (maximum of 2 x 108 viable CAR T cells). A single infusion of YESCARTA is administered to the patient at the YESCARTA Authorized Treatment Center in ~30 minutes.1

    Learn more about the YESCARTA treatment process.

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  • How long are patients monitored at the Authorized Treatment Center?
  • After infusion, the patient is monitored at least daily for 7 days by the YESCARTA Authorized Treatment Center for signs and symptoms of cytokine release syndrome and neurologic toxicities.1 For at least 4 weeks after infusion, the patient should stay within 2 hours of the YESCARTA Authorized Treatment Center.5

    Learn more about the YESCARTA treatment process.

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AUTHORIZED TREATMENT CENTERS
  • How do I find a YESCARTA Authorized Treatment Center?
  • YESCARTA is available only at Authorized Treatment Centers. Use the Treatment Center Locator to find a center that fits your patients’ needs. Be sure to check back often for updates as new centers will be added on an ongoing basis.

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  • How do I get my patient started with YESCARTA?
  • Once a patient has been identified as a potential candidate for YESCARTA, find a YESCARTA Authorized Treatment Center for early consult, evaluation, and preparation. Alternatively, you can call 1-844-454-KITE (5483).

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SUPPORT AND RESOURCES
  • What resources are available to help facilitate a referral?
  • If you’ve identified a patient who is potentially eligible for YESCARTA, find a YESCARTA Authorized Treatment Center for early consult, evaluation, and preparation. You can also call Kite Konnect® at 1-844-454-KITE (5483).

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INDICATION

YESCARTA® is a CD19-directed genetically modified autologous T cell immunotherapy 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES

BOXED WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES

  • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving YESCARTA. Do not administer YESCARTA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
  • Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving YESCARTA, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with YESCARTA. Provide supportive care and/or corticosteroids as needed.
  • YESCARTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the YESCARTA and TECARTUS REMS Program.

CYTOKINE RELEASE SYNDROME (CRS), including fatal or life-threatening reactions, occurred. CRS occurred in 88% (224/254) of all patients with non-Hodgkin lymphoma (NHL), including Grade ≥3 in 10%. CRS occurred in 94% (101/108) of patients with large B-cell lymphoma (LBCL), including Grade ≥3 in 13%. Among patients with LBCL who died after receiving YESCARTA, 4 had ongoing CRS events at the time of death. The median time to onset of CRS was 2 days (range: 1-12 days) and the median duration was 7 days (range: 2-58 days) for patients with LBCL. CRS occurred in 84% (123/146) of patients with indolent non-Hodgkin lymphoma (iNHL), including Grade ≥3 in 8% (11/146). Among patients with iNHL who died after receiving YESCARTA, 1 patient had an ongoing CRS event at the time of death. The median time to onset of CRS was 4 days (range: 1-20 days) and median duration was 6 days (range: 1-27 days) for patients with iNHL. Key manifestations of CRS (≥10%) in all patients combined included fever (80%), hypotension (38%), tachycardia (29%), hypoxia (21%), chills (21%), and headache (13%). Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, multi-organ failure and hemophagocytic lymphohistiocytosis/macrophage activation syndrome. In a subsequent cohort of LBCL patients, tocilizumab and/or corticosteroids were administered for ongoing Grade 1 events. CRS occurred in 93% (38/41) of these patients and 2% (1/41) had Grade 3 CRS, with no patients experiencing 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). Key manifestations of CRS (>5%) included pyrexia, hypotension, chills, headache, nausea, tachycardia, C-reactive protein increased, fatigue, hypoxia, and vomiting. Ensure that 2 doses of tocilizumab are available prior to YESCARTA infusion. Following infusion, monitor patients for signs and symptoms of CRS at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated.

NEUROLOGIC TOXICITIES that were fatal or life-threatening occurred. Neurologic toxicities occurred in 81% (206/254) of all patients with NHL receiving YESCARTA, including Grade ≥3 in 26%. Neurologic toxicities occurred in 87% (94/108) of patients with LBCL, including Grade ≥3 in 31%. The median time to onset was 4 days (range: 1-43 days) and the median duration was 17 days for patients with LBCL. 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: 1-79 days) and the median duration was 16 days for patients with iNHL. 98% 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 infusion for 89% of affected patients with LBCL and 74% of affected patients with iNHL. The most common neurologic toxicities (≥10%) in all patients combined included encephalopathy (53%), headache (45%), tremor (31%), dizziness (20%), delirium (16%), aphasia (15%), and insomnia (11%). Prolonged encephalopathy lasting up to 173 days was noted. Serious events, including leukoencephalopathy and seizures, as well as fatal and serious cases of cerebral edema, have occurred. In a subsequent cohort of LBCL patients who received corticosteroids at the onset of Grade 1 toxicities, neurologic toxicities occurred in 78% (32/41) of these patients and 20% (8/41) had Grade 3 neurologic toxicities with no patients experiencing a Grade 4 or 5 event. The median time to onset of neurologic toxicities was 6 days (range: 1-93 days) with a median duration of 8 days (range: 1-144 days). The most common neurologic toxicities were consistent with the overall LBCL population treated with YESCARTA. Following YESCARTA infusion, monitor patients for signs and symptoms of neurologic toxicities at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter, and treat promptly.

REMS: Because of the risk of CRS and neurologic toxicities, YESCARTA is available only through a restricted program called the YESCARTA and TECARTUS REMS Program which requires that: Healthcare facilities that dispense and administer YESCARTA must be enrolled and comply with the REMS requirements and must have on-site, immediate access to a minimum of 2 doses of tocilizumab for each patient for infusion within 2 hours after YESCARTA infusion, if needed for treatment of CRS. Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer YESCARTA are trained about the management of CRS and neurologic toxicities. Further information is available at www.YescartaTecartusREMS.com or 1-844-454-KITE (5483).

HYPERSENSITIVITY REACTIONS: Allergic reactions, including serious hypersensitivity reactions or anaphylaxis, may occur with the infusion of YESCARTA.

SERIOUS INFECTIONS: Severe or life-threatening infections occurred. Infections (all grades) occurred in 47% (119/254) of all patients with NHL. Grade 3 infections occurred in 19% of patients, Grade 3 infections with an unspecified pathogen occurred in 15%, bacterial infections in 5%, viral infections in 2%, 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 infusion and treat appropriately. Administer prophylactic anti-microbials according to local guidelines. Febrile neutropenia was observed in 40% of all patients with NHL 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 (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

PROLONGED CYTOPENIAS: Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion. Grade 3 cytopenias not resolved by Day 30 following YESCARTA infusion occurred in 30% of all patients with NHL and included neutropenia (22%), thrombocytopenia (13%), and anemia (5%). Monitor blood counts after infusion.

HYPOGAMMAGLOBULINEMIA and B-cell aplasia can occur. Hypogammaglobulinemia occurred in 17% of all patients with NHL. Monitor immunoglobulin levels after treatment 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.

SECONDARY MALIGNANCIES may develop. Monitor life-long for secondary malignancies. In the event that one occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following YESCARTA infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

ADVERSE REACTIONS: The most common non-laboratory adverse reactions (incidence 20%) in patients with iNHL 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.

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

INDICATION

YESCARTA® is a CD19-directed genetically modified autologous T cell immunotherapy 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES

BOXED WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES

  • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving YESCARTA. Do not administer YESCARTA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
  • Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving YESCARTA, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with YESCARTA. Provide supportive care and/or corticosteroids as needed.
  • YESCARTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the YESCARTA and TECARTUS REMS Program.

CYTOKINE RELEASE SYNDROME (CRS), including fatal or life-threatening reactions, occurred. CRS occurred in 88% (224/254) of all patients with non-Hodgkin lymphoma (NHL), including Grade ≥3 in 10%. CRS occurred in 94% (101/108) of patients with large B-cell lymphoma (LBCL), including Grade ≥3 in 13%. Among patients with LBCL who died after receiving YESCARTA, 4 had ongoing CRS events at the time of death. The median time to onset of CRS was 2 days (range: 1-12 days) and the median duration was 7 days (range: 2-58 days) for patients with LBCL. CRS occurred in 84% (123/146) of patients with indolent non-Hodgkin lymphoma (iNHL), including Grade ≥3 in 8% (11/146). Among patients with iNHL who died after receiving YESCARTA, 1 patient had an ongoing CRS event at the time of death. The median time to onset of CRS was 4 days (range: 1-20 days) and median duration was 6 days (range: 1-27 days) for patients with iNHL. Key manifestations of CRS (≥10%) in all patients combined included fever (80%), hypotension (38%), tachycardia (29%), hypoxia (21%), chills (21%), and headache (13%). Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, multi-organ failure and hemophagocytic lymphohistiocytosis/macrophage activation syndrome. In a subsequent cohort of LBCL patients, tocilizumab and/or corticosteroids were administered for ongoing Grade 1 events. CRS occurred in 93% (38/41) of these patients and 2% (1/41) had Grade 3 CRS, with no patients experiencing 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). Key manifestations of CRS (>5%) included pyrexia, hypotension, chills, headache, nausea, tachycardia, C-reactive protein increased, fatigue, hypoxia, and vomiting. Ensure that 2 doses of tocilizumab are available prior to YESCARTA infusion. Following infusion, monitor patients for signs and symptoms of CRS at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated.

NEUROLOGIC TOXICITIES that were fatal or life-threatening occurred. Neurologic toxicities occurred in 81% (206/254) of all patients with NHL receiving YESCARTA, including Grade ≥3 in 26%. Neurologic toxicities occurred in 87% (94/108) of patients with LBCL, including Grade ≥3 in 31%. The median time to onset was 4 days (range: 1-43 days) and the median duration was 17 days for patients with LBCL. 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: 1-79 days) and the median duration was 16 days for patients with iNHL. 98% 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 infusion for 89% of affected patients with LBCL and 74% of affected patients with iNHL. The most common neurologic toxicities (≥10%) in all patients combined included encephalopathy (53%), headache (45%), tremor (31%), dizziness (20%), delirium (16%), aphasia (15%), and insomnia (11%). Prolonged encephalopathy lasting up to 173 days was noted. Serious events, including leukoencephalopathy and seizures, as well as fatal and serious cases of cerebral edema, have occurred. In a subsequent cohort of LBCL patients who received corticosteroids at the onset of Grade 1 toxicities, neurologic toxicities occurred in 78% (32/41) of these patients and 20% (8/41) had Grade 3 neurologic toxicities with no patients experiencing a Grade 4 or 5 event. The median time to onset of neurologic toxicities was 6 days (range: 1-93 days) with a median duration of 8 days (range: 1-144 days). The most common neurologic toxicities were consistent with the overall LBCL population treated with YESCARTA. Following YESCARTA infusion, monitor patients for signs and symptoms of neurologic toxicities at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter, and treat promptly.

REMS: Because of the risk of CRS and neurologic toxicities, YESCARTA is available only through a restricted program called the YESCARTA and TECARTUS REMS Program which requires that: Healthcare facilities that dispense and administer YESCARTA must be enrolled and comply with the REMS requirements and must have on-site, immediate access to a minimum of 2 doses of tocilizumab for each patient for infusion within 2 hours after YESCARTA infusion, if needed for treatment of CRS. Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer YESCARTA are trained about the management of CRS and neurologic toxicities. Further information is available at www.YescartaTecartusREMS.com or 1-844-454-KITE (5483).

HYPERSENSITIVITY REACTIONS: Allergic reactions, including serious hypersensitivity reactions or anaphylaxis, may occur with the infusion of YESCARTA.

SERIOUS INFECTIONS: Severe or life-threatening infections occurred. Infections (all grades) occurred in 47% (119/254) of all patients with NHL. Grade 3 infections occurred in 19% of patients, Grade 3 infections with an unspecified pathogen occurred in 15%, bacterial infections in 5%, viral infections in 2%, 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 infusion and treat appropriately. Administer prophylactic anti-microbials according to local guidelines. Febrile neutropenia was observed in 40% of all patients with NHL 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 (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

PROLONGED CYTOPENIAS: Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion. Grade 3 cytopenias not resolved by Day 30 following YESCARTA infusion occurred in 30% of all patients with NHL and included neutropenia (22%), thrombocytopenia (13%), and anemia (5%). Monitor blood counts after infusion.

HYPOGAMMAGLOBULINEMIA and B-cell aplasia can occur. Hypogammaglobulinemia occurred in 17% of all patients with NHL. Monitor immunoglobulin levels after treatment 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.

SECONDARY MALIGNANCIES may develop. Monitor life-long for secondary malignancies. In the event that one occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following YESCARTA infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

ADVERSE REACTIONS: The most common non-laboratory adverse reactions (incidence 20%) in patients with iNHL 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.

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

INDICATION

YESCARTA® is a CD19-directed genetically modified autologous T cell immunotherapy 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES

BOXED WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES

  • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving YESCARTA. Do not administer YESCARTA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
  • Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving YESCARTA, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with YESCARTA. Provide supportive care and/or corticosteroids as needed.
  • YESCARTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the YESCARTA and TECARTUS REMS Program.

CYTOKINE RELEASE SYNDROME (CRS), including fatal or life-threatening reactions, occurred. CRS occurred in 88% (224/254) of all patients with non-Hodgkin lymphoma (NHL), including Grade ≥3 in 10%. CRS occurred in 94% (101/108) of patients with large B-cell lymphoma (LBCL), including Grade ≥3 in 13%. Among patients with LBCL who died after receiving YESCARTA, 4 had ongoing CRS events at the time of death. The median time to onset of CRS was 2 days (range: 1-12 days) and the median duration was 7 days (range: 2-58 days) for patients with LBCL. CRS occurred in 84% (123/146) of patients with indolent non-Hodgkin lymphoma (iNHL), including Grade ≥3 in 8% (11/146). Among patients with iNHL who died after receiving YESCARTA, 1 patient had an ongoing CRS event at the time of death. The median time to onset of CRS was 4 days (range: 1-20 days) and median duration was 6 days (range: 1-27 days) for patients with iNHL. Key manifestations of CRS (≥10%) in all patients combined included fever (80%), hypotension (38%), tachycardia (29%), hypoxia (21%), chills (21%), and headache (13%). Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, multi-organ failure and hemophagocytic lymphohistiocytosis/macrophage activation syndrome. In a subsequent cohort of LBCL patients, tocilizumab and/or corticosteroids were administered for ongoing Grade 1 events. CRS occurred in 93% (38/41) of these patients and 2% (1/41) had Grade 3 CRS, with no patients experiencing 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). Key manifestations of CRS (>5%) included pyrexia, hypotension, chills, headache, nausea, tachycardia, C-reactive protein increased, fatigue, hypoxia, and vomiting. Ensure that 2 doses of tocilizumab are available prior to YESCARTA infusion. Following infusion, monitor patients for signs and symptoms of CRS at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated.

NEUROLOGIC TOXICITIES that were fatal or life-threatening occurred. Neurologic toxicities occurred in 81% (206/254) of all patients with NHL receiving YESCARTA, including Grade ≥3 in 26%. Neurologic toxicities occurred in 87% (94/108) of patients with LBCL, including Grade ≥3 in 31%. The median time to onset was 4 days (range: 1-43 days) and the median duration was 17 days for patients with LBCL. 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: 1-79 days) and the median duration was 16 days for patients with iNHL. 98% 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 infusion for 89% of affected patients with LBCL and 74% of affected patients with iNHL. The most common neurologic toxicities (≥10%) in all patients combined included encephalopathy (53%), headache (45%), tremor (31%), dizziness (20%), delirium (16%), aphasia (15%), and insomnia (11%). Prolonged encephalopathy lasting up to 173 days was noted. Serious events, including leukoencephalopathy and seizures, as well as fatal and serious cases of cerebral edema, have occurred. In a subsequent cohort of LBCL patients who received corticosteroids at the onset of Grade 1 toxicities, neurologic toxicities occurred in 78% (32/41) of these patients and 20% (8/41) had Grade 3 neurologic toxicities with no patients experiencing a Grade 4 or 5 event. The median time to onset of neurologic toxicities was 6 days (range: 1-93 days) with a median duration of 8 days (range: 1-144 days). The most common neurologic toxicities were consistent with the overall LBCL population treated with YESCARTA. Following YESCARTA infusion, monitor patients for signs and symptoms of neurologic toxicities at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter, and treat promptly.

REMS: Because of the risk of CRS and neurologic toxicities, YESCARTA is available only through a restricted program called the YESCARTA and TECARTUS REMS Program which requires that: Healthcare facilities that dispense and administer YESCARTA must be enrolled and comply with the REMS requirements and must have on-site, immediate access to a minimum of 2 doses of tocilizumab for each patient for infusion within 2 hours after YESCARTA infusion, if needed for treatment of CRS. Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer YESCARTA are trained about the management of CRS and neurologic toxicities. Further information is available at www.YescartaTecartusREMS.com or 1-844-454-KITE (5483).

HYPERSENSITIVITY REACTIONS: Allergic reactions, including serious hypersensitivity reactions or anaphylaxis, may occur with the infusion of YESCARTA.

SERIOUS INFECTIONS: Severe or life-threatening infections occurred. Infections (all grades) occurred in 47% (119/254) of all patients with NHL. Grade 3 infections occurred in 19% of patients, Grade 3 infections with an unspecified pathogen occurred in 15%, bacterial infections in 5%, viral infections in 2%, 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 infusion and treat appropriately. Administer prophylactic anti-microbials according to local guidelines. Febrile neutropenia was observed in 40% of all patients with NHL 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 (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

PROLONGED CYTOPENIAS: Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion. Grade 3 cytopenias not resolved by Day 30 following YESCARTA infusion occurred in 30% of all patients with NHL and included neutropenia (22%), thrombocytopenia (13%), and anemia (5%). Monitor blood counts after infusion.

HYPOGAMMAGLOBULINEMIA and B-cell aplasia can occur. Hypogammaglobulinemia occurred in 17% of all patients with NHL. Monitor immunoglobulin levels after treatment 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.

SECONDARY MALIGNANCIES may develop. Monitor life-long for secondary malignancies. In the event that one occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following YESCARTA infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

ADVERSE REACTIONS: The most common non-laboratory adverse reactions (incidence 20%) in patients with iNHL 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.

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

Authorized Treatment Centers (ATCs) are independently owned and operated. Kite does not endorse any Authorized Treatment Center.

References: 1. YESCARTA® (axicabtagene ciloleucel). Prescribing information. Kite Pharma, Inc; 2021. 2. A phase 2 multicenter study of axicabtagene ciloleucel in subjects with relapsed/refractory indolent non-Hodgkin lymphoma (ZUMA-5). Clinicaltrials.gov. Published April 7, 2017. Updated February 25, 2021. Accessed March 5, 2021. Clinicaltrials.gov. https://clinicaltrials.gov/ct2/show/NCT03105336 3. Data on file. Kite Pharma, Inc; 2020. 4. Roberts ZJ, Better M, Bot A, Roberts MR, Ribas A. Axicabtagene ciloleucel, a first-in-class CAR T cell therapy for aggressive NHL. Leuk Lymphoma. 2018;59(8):1785-1796. 5. YESCARTA and TECARTUS REMS Patient Wallet Card. REMS-CTF-0023. March 2021.