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SUPPORT AND RESOURCES

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

KITE KONNECT®: DEDICATED SUPPORT THROUGHOUT THE TREATMENT PROCESS

Kite Konnect: Providing patients and healthcare professionals information on Authorized Treatment Centers.

Find a Treatment Center

Provide patients and healthcare professionals information on CAR T Authorized Treatment Centers.

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

Logistics Support

Patients can learn about potential resources 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 uninsured and underinsured patients.

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

Enroll a Patient

Register a patient for therapy if you are a healthcare professional.

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

Ongoing Commitment

Kite Konnect® Case Managers are available to support healthcare professionals and patients 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], Monday–Friday, 5 am–6 pm PT.

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], Monday–Friday, 5 am–6 pm PT.

VVisit Kite Konnect, your resource throughout the treatment process.

Dedicated support throughout the treatment journey.

Visit KiteKonnect.com

Or call Kite Konnect® at 1-844-454-KITE [5483], Monday–Friday, 5 am–6 pm PT.

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-ζ 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

    *The median time from leukapheresis to product delivery.


    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 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

    Note: 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 r/r 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

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


    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?
  • ZUMA-5 was 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

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

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


    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 time‡§ 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)

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

    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

    DOR=duration of response.

    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)

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


    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)

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

    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)

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

    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

    CRS=cytokine release syndrome.

    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)

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

    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

    CRS=cytokine release syndrome.


    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)

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

    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).

    ǁData 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, neurologic toxicities, and any other side effects.1 For at least 4 weeks after infusion, the patient should stay within 2 hours of the YESCARTA Authorized Treatment Center.1,5

    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 patient’s needs. Be sure to check back often for updates as new centers will be added on an ongoing basis.1

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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 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

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)

CRS, including fatal or life-threatening reactions, occurred. CRS occurred in 90% (379/422) of patients with non-Hodgkin lymphoma (NHL), including Grade 3 in 9%. CRS occurred in 93% (256/276) of patients with large B-cell lymphoma (LBCL), including Grade 3 in 9%. Among patients with LBCL who died after receiving YESCARTA, 4 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: 1-12 days) and the median duration was 7 days (range: 2-58 days). For patients with LBCL in ZUMA-7, the median time to onset of CRS was 3 days following infusion (range: 1-10 days) and the median duration was 7 days (range: 2-43 days). CRS occurred in 84% (123/146) of patients with indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5, including Grade 3 in 8%. 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 (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.

The impact of tocilizumab and/or corticosteroids on the incidence and severity of CRS was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received tocilizumab and/or corticosteroids for ongoing Grade 1 events, 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: 1-8 days) and the median duration of CRS was 7 days (range: 2-16 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Thirty-one of the 39 patients (79%) developed CRS and were managed with tocilizumab and/or therapeutic doses of corticosteroids with no patients developing Grade 3 CRS. The median time to onset of CRS was 5 days (range: 1-15 days) and the median duration of CRS was 4 days (range: 1-10 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.

Ensure that 2 doses of tocilizumab are available prior to YESCARTA 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

Neurologic toxicities (including immune effector cell-associated neurotoxicity syndrome) that were fatal or life-threatening occurred. Neurologic toxicities occurred in 78% (330/422) of patients with NHL receiving YESCARTA, including Grade 3 in 25%. Neurologic toxicities occurred in 87% (94/108) of patients with LBCL in ZUMA-1, including Grade 3 in 31% and in 74% (124/168) of patients in ZUMA-7 including Grade 3 in 25%. The median time to onset was 4 days (range: 1-43 days) and the median duration was 17 days for patients with LBCL in ZUMA-1. The median time to onset for neurologic toxicity was 5 days (range: 1-133 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: 1-79 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 infusion for 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. Fatal and serious cases of cerebral edema and encephalopathy, including late-onset encephalopathy, have occurred.

The impact of tocilizumab and/or corticosteroids on the incidence and severity of neurologic toxicities was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received corticosteroids at the onset of Grade 1 toxicities, 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: 1-93 days) with a median duration of 8 days (range: 1-144 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Of those 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 neurologic toxicities was 6 days (range: 1-274 days) with a median duration of 12 days (range: 1-107 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.

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 45% of patients with NHL. Grade 3 infections occurred in 17% of patients, including Grade 3 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 infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines.

Febrile neutropenia was observed in 36% of 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, 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.

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 39% of all patients with NHL and included neutropenia (33%), thrombocytopenia (13%), and anemia (8%). Monitor blood counts after infusion.

HYPOGAMMAGLOBULINEMIA

B-cell aplasia and hypogammaglobulinemia can occur. Hypogammaglobulinemia was reported as an adverse reaction in 14% 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

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 in ZUMA-5 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 accompanying 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

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)

CRS, including fatal or life-threatening reactions, occurred. CRS occurred in 90% (379/422) of patients with non-Hodgkin lymphoma (NHL), including Grade 3 in 9%. CRS occurred in 93% (256/276) of patients with large B-cell lymphoma (LBCL), including Grade 3 in 9%. Among patients with LBCL who died after receiving YESCARTA, 4 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: 1-12 days) and the median duration was 7 days (range: 2-58 days). For patients with LBCL in ZUMA-7, the median time to onset of CRS was 3 days following infusion (range: 1-10 days) and the median duration was 7 days (range: 2-43 days). CRS occurred in 84% (123/146) of patients with indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5, including Grade 3 in 8%. 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 (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.

The impact of tocilizumab and/or corticosteroids on the incidence and severity of CRS was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received tocilizumab and/or corticosteroids for ongoing Grade 1 events, 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: 1-8 days) and the median duration of CRS was 7 days (range: 2-16 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Thirty-one of the 39 patients (79%) developed CRS and were managed with tocilizumab and/or therapeutic doses of corticosteroids with no patients developing Grade 3 CRS. The median time to onset of CRS was 5 days (range: 1-15 days) and the median duration of CRS was 4 days (range: 1-10 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.

Ensure that 2 doses of tocilizumab are available prior to YESCARTA 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

Neurologic toxicities (including immune effector cell-associated neurotoxicity syndrome) that were fatal or life-threatening occurred. Neurologic toxicities occurred in 78% (330/422) of patients with NHL receiving YESCARTA, including Grade 3 in 25%. Neurologic toxicities occurred in 87% (94/108) of patients with LBCL in ZUMA-1, including Grade 3 in 31% and in 74% (124/168) of patients in ZUMA-7 including Grade 3 in 25%. The median time to onset was 4 days (range: 1-43 days) and the median duration was 17 days for patients with LBCL in ZUMA-1. The median time to onset for neurologic toxicity was 5 days (range: 1-133 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: 1-79 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 infusion for 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. Fatal and serious cases of cerebral edema and encephalopathy, including late-onset encephalopathy, have occurred.

The impact of tocilizumab and/or corticosteroids on the incidence and severity of neurologic toxicities was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received corticosteroids at the onset of Grade 1 toxicities, 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: 1-93 days) with a median duration of 8 days (range: 1-144 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Of those 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 neurologic toxicities was 6 days (range: 1-274 days) with a median duration of 12 days (range: 1-107 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.

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 45% of patients with NHL. Grade 3 infections occurred in 17% of patients, including Grade 3 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 infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines.

Febrile neutropenia was observed in 36% of 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, 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.

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 39% of all patients with NHL and included neutropenia (33%), thrombocytopenia (13%), and anemia (8%). Monitor blood counts after infusion.

HYPOGAMMAGLOBULINEMIA

B-cell aplasia and hypogammaglobulinemia can occur. Hypogammaglobulinemia was reported as an adverse reaction in 14% 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

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 in ZUMA-5 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 accompanying 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

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)

CRS, including fatal or life-threatening reactions, occurred. CRS occurred in 90% (379/422) of patients with non-Hodgkin lymphoma (NHL), including Grade 3 in 9%. CRS occurred in 93% (256/276) of patients with large B-cell lymphoma (LBCL), including Grade 3 in 9%. Among patients with LBCL who died after receiving YESCARTA, 4 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: 1-12 days) and the median duration was 7 days (range: 2-58 days). For patients with LBCL in ZUMA-7, the median time to onset of CRS was 3 days following infusion (range: 1-10 days) and the median duration was 7 days (range: 2-43 days). CRS occurred in 84% (123/146) of patients with indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5, including Grade 3 in 8%. 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 (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.

The impact of tocilizumab and/or corticosteroids on the incidence and severity of CRS was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received tocilizumab and/or corticosteroids for ongoing Grade 1 events, 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: 1-8 days) and the median duration of CRS was 7 days (range: 2-16 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Thirty-one of the 39 patients (79%) developed CRS and were managed with tocilizumab and/or therapeutic doses of corticosteroids with no patients developing Grade 3 CRS. The median time to onset of CRS was 5 days (range: 1-15 days) and the median duration of CRS was 4 days (range: 1-10 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.

Ensure that 2 doses of tocilizumab are available prior to YESCARTA 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

Neurologic toxicities (including immune effector cell-associated neurotoxicity syndrome) that were fatal or life-threatening occurred. Neurologic toxicities occurred in 78% (330/422) of patients with NHL receiving YESCARTA, including Grade 3 in 25%. Neurologic toxicities occurred in 87% (94/108) of patients with LBCL in ZUMA-1, including Grade 3 in 31% and in 74% (124/168) of patients in ZUMA-7 including Grade 3 in 25%. The median time to onset was 4 days (range: 1-43 days) and the median duration was 17 days for patients with LBCL in ZUMA-1. The median time to onset for neurologic toxicity was 5 days (range: 1-133 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: 1-79 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 infusion for 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. Fatal and serious cases of cerebral edema and encephalopathy, including late-onset encephalopathy, have occurred.

The impact of tocilizumab and/or corticosteroids on the incidence and severity of neurologic toxicities was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received corticosteroids at the onset of Grade 1 toxicities, 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: 1-93 days) with a median duration of 8 days (range: 1-144 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Of those 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 neurologic toxicities was 6 days (range: 1-274 days) with a median duration of 12 days (range: 1-107 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.

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 45% of patients with NHL. Grade 3 infections occurred in 17% of patients, including Grade 3 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 infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines.

Febrile neutropenia was observed in 36% of 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, 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.

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 39% of all patients with NHL and included neutropenia (33%), thrombocytopenia (13%), and anemia (8%). Monitor blood counts after infusion.

HYPOGAMMAGLOBULINEMIA

B-cell aplasia and hypogammaglobulinemia can occur. Hypogammaglobulinemia was reported as an adverse reaction in 14% 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

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 in ZUMA-5 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 accompanying full Prescribing Information, including BOXED WARNING and Medication Guide.

Authorized Treatment Centers are independent facilities certified to dispense Kite CAR T therapies. Choice of an Authorized Treatment Center is within the sole discretion of the physician and patient. Kite does not endorse any individual treatment sites.

Resources may include referrals to independent third-party nonprofit patient assistance programs. These programs are not operated or controlled by Kite. Nonprofit patient assistance program eligibility requirements may vary and are established solely by each independent organization. Kite makes no guarantee with respect to reimbursement or copay assistance for any item or service.

Cell therapy patient programs are for eligible prescribed patients.

CAR T=chimeric antigen receptor T cell.

References: 1. YESCARTA® (axicabtagene ciloleucel). Prescribing information. Kite Pharma, Inc; 2021. 2. Zhang C, Liu J, Zhong JF, et al. Engineering CAR-T cells. Biomark Res. 2017;5(22):1-6. 3. 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 June 3, 2021. Accessed July 21, 2021. https://clinicaltrials.gov/ct2/show/NCT03105336 4. Data on file. Kite Pharma, Inc; 2020. 5. 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. doi: 10.1080/10428194.2017.1387905 6. YESCARTA® and TECARTUS REMS Patient Wallet Card. REMS-CTF-0023. March 2021.