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

Kite Konnect® can direct patients to an Authorized Treatment Center near them.

Kite Konnect: Search a directory of independent, nationwide programs for patient assistance, including housing, transportation, and financial support.

Travel Support

Kite Konnect® can provide information about transportation and housing resources that may be available to your patient.

Kite Konnect: Search a directory of independent, nationwide programs for patient assistance, including housing, transportation, and financial support.

Reimbursement Support

Benefits investigations, claims appeals information, and support for eligible and underinsured patients.

Kite Konnect: We're committed to supporting you and your patients throughout treatment.

Ongoing Commitment

Case managers support before, during, and after treatment.

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).

Resources from the Kite Konnect® Referral Portal

Find patient eligibility information, educational and support resources for patients, and more.

Visit KITEKONNECTREFER.com

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

Coverage Support

100%
Coverage
  • 100% of targeted commercial and Medicare plans have confirmed coverage for YESCARTA1*
  • The Centers for Medicare & Medicaid Services has issued a national coverage determination covering approved CAR T therapies and related services2

Use this interactive map to learn about insurance coverage in your patient’s area.

View coverage in your area

*Targeted commercial plans have 100,000 lives or greater. Data as of March 2020. Coverage may vary by patient or by plan. Contact the insurer for more information.

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.3

    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 CD3ζ 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.3

    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). The latest real-world data have demonstrated a median time of 16 days from leukapheresis to product release4* and a 96% success rate in manufacturing CAR T cells.5*

    *Data as of March 31, 2020.


    Learn more about the manufacturing process of YESCARTA.

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ELIGIBILITY
  • At what point in treatment is YESCARTA an option?
  • YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after 2 lines of systemic therapy. Once a patient has relapsed and/or is refractory to 2 lines of systemic therapy, they are potentially eligible for YESCARTA. Early patient identification is critical to outcomes. It’s important to know when to consider YESCARTA.3

    Limitation of Use: YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma.

    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 treated in the ZUMA-1 pivotal trial ranged from 23 to 76 years with a median of 58 years (N=101). At the median follow-up of 11.6-months, the overall response rate per independent review committee was 72%. 24% of patients who were aged 65 years or older demonstrated a 92% objective response rate (95% CI: 0.73, 0.99) as determined by an investigator-assessed subgroup analysis at an 8.7-month median follow-up.3,6†

    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.

    Data from the investigator analysis of ZUMA-1 is based on assessments performed by individual investigators at their respective trial sites and should be interpreted with caution. Investigator-assessed data are not included in the full Prescribing Information. For FDA approval, efficacy was established on the basis of complete remission rate and duration of response, as determined by an independent review committee.

    Subgroup data not included in the full Prescribing Information. The efficacy in these subgroups was not a study objective and the study was not powered to assess efficacy in these subgroups.

    ZUMA-1 STUDY DESIGN

    • YESCARTA was studied in a phase 2, open-label, single-arm, multicenter trial in 101 adults with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma
    • Patients had refractory disease to the most recent therapy or relapsed within 1 year after autologous stem cell transplantation (ASCT)
    • 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 (maximum of 2 x 108 viable CAR T cells)
    • Bridging chemotherapy between leukapheresis and lymphodepleting chemotherapy was not permitted
      • In the commercial setting, the use of bridging therapy after leukapheresis and before lymphodepleting chemotherapy is at the discretion of the treating physician
    See what types of patients are potentially eligible for YESCARTA.

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  • How many patients have been treated with YESCARTA?
  • YESCARTA is the only CAR T therapy to have treated more than 3500 patients.7‡

    Global commercial and clinical trial data in patients with relapsed/refractory LBCL after 2 lines of systemic therapy as of August 2, 2020.


    See what types of patients are potentially eligible for YESCARTA.

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ZUMA-1 PIVOTAL TRIAL DESIGN
  • How was the ZUMA-1 pivotal trial designed?
  • YESCARTA was studied in a phase 2, open-label, single-arm, multicenter trial in 101 adults with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma.3,6

    • Patients had refractory disease to the most recent therapy or relapsed within 1 year after autologous stem cell transplantation
    • 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 (maximum of 2 x 108 viable CAR T cells)
    • Bridging chemotherapy between leukapheresis and lymphodepleting chemotherapy was not permitted§

    §In the commercial setting, the use of bridging therapy after leukapheresis and before lymphodepleting chemotherapy is at the discretion of the treating physician.


    Learn more about the design and data of the ZUMA-1 pivotal trial.

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  • What types of patients were studied?
  • The ZUMA-1 population spanned a wide range of patients with progressive disease, including3,6:

    • 24% were aged 65 years or older
    • 77% were refractory to 2 lines of therapy
    • 21% had relapsed 1 year after autologous stem cell transplantation

    Learn more about the design and data of the ZUMA-1 pivotal trial.

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  • What were the endpoints of ZUMA-1?
  • The primary endpoint of the ZUMA-1 pivotal trial was the proportion of patients achieving an objective response (ie, the combined proportion of participants who had a complete or partial response). Select secondary endpoints included duration of response (defined as the time from first objective response to disease progression or death from any cause) and overall survival (defined as the time from infusion to the date of death from any cause).8

    For FDA approval, efficacy was established on the basis of complete remission rate and duration of response, as determined by an independent review committee.


    Learn more about the design and data of the ZUMA-1 pivotal trial.

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  • What was the manufacturing success rate for Kite in the ZUMA-1 pivotal trial?
  • In the ZUMA-1 pivotal trial, Kite demonstrated a 17-day median turnaround time‖¶ and 99% success rate in manufacturing CAR T cells.3‖ The latest real-world data have demonstrated a median time of 16 days from leukapheresis to product release4# and a 96% success rate in manufacturing CAR T cells.5#

    Data reflect results from the ZUMA-1 pivotal trial.

    The median time from leukapheresis to product delivery.

    #Data as of March 31, 2020.


    Learn more about the manufacturing process of YESCARTA.

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ZUMA-1 EFFICACY
  • What was the overall response rate? Complete remission rate? Partial remission rate?
  • At an 11.6-month median follow-up, the objective response rate was 72%, the complete remission rate was 51%, and the partial remission rate was 21% (N=101; independent review committee).3,9

    At a later 27.1-month median follow-up, the objective response rate was 74%, the complete remission rate was 54%, and the partial remission rate was 20% (N=101; independent review committee).8**

    **Data from the 27.1-month median follow-up of ZUMA-1 are not included in the Prescribing Information and should be carefully interpreted.

    ZUMA-1 STUDY DESIGN

    • YESCARTA was studied in a phase 2, open-label, single-arm, multicenter trial in 101 adults with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma
    • Patients had refractory disease to the most recent therapy or relapsed within 1 year after autologous stem cell transplantation (ASCT)
    • 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 (maximum of 2 x 108 viable CAR T cells)
    • Bridging chemotherapy between leukapheresis and lymphodepleting chemotherapy was not permitted
      • In the commercial setting, the use of bridging therapy after leukapheresis and before lymphodepleting chemotherapy is at the discretion of the treating physician
    Learn more about the efficacy data from the ZUMA-1 pivotal trial.

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  • For how long were patients followed? What was the duration of response?
  • Patients in the ZUMA-1 pivotal trial were initially followed for a median of 11.6 months.9 At a median follow-up of 27.1 months, the median duration of response was not yet reached.8

    • At the time of FDA approval, the median follow-up was 11.6 months.9 Efficacy was established on the basis of CR rate and DOR, as determined by an independent review committee. At this time, the median DOR for all responders was 9.2 months (95% CI: 5.4, NR). The median DOR if best response was CR was not reached (95% CI: 8.1, NR); if best response was PR, the median DOR was 2.1 months (95% CI: 1.3, 5.3). In the pivotal trial, of the 52 patients who achieved CR, 14 initially had stable disease (7 patients) or PR (7 patients), with a median time to improvement of 2.1 months (range: 1.6 to 5.3 months)3
    • The median DOR in the updated analysis (median follow-up of 27.1 months) for all responders was not reached (95% CI: 10.9, NR). Two patients previously read as not evaluable were determined to be in CR upon follow-up disease assessments, leading to a prolongation of the DOR. The median DOR if best response was CR was not reached (95% CI: NR, NR)10
    • Data from the 27.1-month median follow-up of ZUMA-1 are not included in the PI and should be carefully interpreted

    CR=complete remission; DOR=duration of response; NR=not reached; PI=Prescribing Information; PR=partial remission.

    ZUMA-1 STUDY DESIGN

    • YESCARTA was studied in a phase 2, open-label, single-arm, multicenter trial in 101 adults with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma
    • Patients had refractory disease to the most recent therapy or relapsed within 1 year after autologous stem cell transplantation (ASCT)
    • 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 (maximum of 2 x 108 viable CAR T cells)
    • Bridging chemotherapy between leukapheresis and lymphodepleting chemotherapy was not permitted
      • In the commercial setting, the use of bridging therapy after leukapheresis and before lymphodepleting chemotherapy is at the discretion of the treating physician
    Learn more about the efficacy data from the ZUMA-1 pivotal trial.

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  • What percentage of patients were still alive at the latest follow-up?
  • At the median follow-up of 11.6-months, the overall response rate was 72%.3,9 Overall survival (OS) is a secondary endpoint of ZUMA-1.8 ~Half of the patients were alive after 3 years (47% alive and 25.8-month median OS with a 39.1-month median follow-up).11††

    ††ZUMA-1 was a phase 2, open-label, single-arm, multicenter pivotal trial in 101 adults with relapsed or refractory large B-cell lymphoma. For FDA approval, efficacy was established on the basis of complete remission rate and duration of response, as determined by an independent review committee.3,8 OS was a secondary endpoint in the ZUMA-1 trial.8 OS data are descriptive and should be carefully interpreted in light of the single-arm design. OS data are not included in the Prescribing Information for YESCARTA. Not all data continued to be captured at the 3-year follow-up; only OS, investigator-assessed response, and adverse event reporting were captured.12

    ZUMA-1 STUDY DESIGN

    • YESCARTA was studied in a phase 2, open-label, single-arm, multicenter trial in 101 adults with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma
    • Patients had refractory disease to the most recent therapy or relapsed within 1 year after autologous stem cell transplantation (ASCT)
    • 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 (maximum of 2 x 108 viable CAR T cells)
    • Bridging chemotherapy between leukapheresis and lymphodepleting chemotherapy was not permitted
      • In the commercial setting, the use of bridging therapy after leukapheresis and before lymphodepleting chemotherapy is at the discretion of the treating physician
    Learn more about the efficacy data from the ZUMA-1 pivotal trial.

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ZUMA-1 SAFETY
  • What was the overall incidence of cytokine release syndrome (CRS)? What was the incidence of Grade 3 CRS?
  • In the ZUMA-1 pivotal trial, CRS occurred in 94% (101/108) of patients receiving YESCARTA, including Grade 3 CRS in 13% (14/108) of patients. The median time to onset was 2 days (range: 1 to 12 days) and the median duration of CRS was 7 days (range: 2 to 58 days).3

    ZUMA-1 STUDY DESIGN

    • YESCARTA was studied in a phase 2, open-label, single-arm, multicenter trial in 101 adults with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma
    • Patients had refractory disease to the most recent therapy or relapsed within 1 year after autologous stem cell transplantation (ASCT)
    • 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 (maximum of 2 x 108 viable CAR T cells)
    • Bridging chemotherapy between leukapheresis and lymphodepleting chemotherapy was not permitted
      • In the commercial setting, the use of bridging therapy after leukapheresis and before lymphodepleting chemotherapy is at the discretion of the treating physician
    Learn more about the safety profile from the ZUMA-1 pivotal trial.

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  • What was the overall incidence of neurologic toxicities? What was the incidence of Grade 3 neurologic toxicities?
  • In the ZUMA-1 pivotal trial, neurologic toxicities occurred in 87% of patients, with 31% of patients experiencing Grade 3 neurologic toxicities. The median time to onset was 4 days (range: 1 to 43 days) and the median duration was 17 days.3

    ZUMA-1 STUDY DESIGN

    • YESCARTA was studied in a phase 2, open-label, single-arm, multicenter trial in 101 adults with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma
    • Patients had refractory disease to the most recent therapy or relapsed within 1 year after autologous stem cell transplantation (ASCT)
    • 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 (maximum of 2 x 108 viable CAR T cells)
    • Bridging chemotherapy between leukapheresis and lymphodepleting chemotherapy was not permitted
      • In the commercial setting, the use of bridging therapy after leukapheresis and before lymphodepleting chemotherapy is at the discretion of the treating physician
    Learn more about the safety profile from the ZUMA-1 pivotal trial.

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  • What were the most common adverse reactions? What percentage of patients experienced serious adverse reactions?
  • The most common adverse reactions (incidence 20%) include cytokine release syndrome, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections-pathogen unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias.3

    Serious adverse reactions occurred in 52% of patients. The most common serious adverse reactions (>2%) included encephalopathy, fever, lung infection, febrile neutropenia, cardiac arrhythmia, cardiac failure, urinary tract infection, renal insufficiency, aphasia, cardiac arrest, Clostridium difficile infection, delirium, hypotension, and hypoxia.3

    ZUMA-1 STUDY DESIGN

    • YESCARTA was studied in a phase 2, open-label, single-arm, multicenter trial in 101 adults with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma
    • Patients had refractory disease to the most recent therapy or relapsed within 1 year after autologous stem cell transplantation (ASCT)
    • 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 (maximum of 2 x 108 viable CAR T cells)
    • Bridging chemotherapy between leukapheresis and lymphodepleting chemotherapy was not permitted
      • In the commercial setting, the use of bridging therapy after leukapheresis and before lymphodepleting chemotherapy is at the discretion of the treating physician
    Learn more about the safety profile from the ZUMA-1 pivotal trial.

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  • What were the most common Grade 3 reactions?
  • The most common (10%) Grade 3 reactions included febrile neutropenia, fever, cytokine release syndrome, encephalopathy, infections-pathogen unspecified, hypotension, hypoxia, and lung infections.3

    ZUMA-1 STUDY DESIGN

    • YESCARTA was studied in a phase 2, open-label, single-arm, multicenter trial in 101 adults with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma
    • Patients had refractory disease to the most recent therapy or relapsed within 1 year after autologous stem cell transplantation (ASCT)
    • 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 (maximum of 2 x 108 viable CAR T cells)
    • Bridging chemotherapy between leukapheresis and lymphodepleting chemotherapy was not permitted
      • In the commercial setting, the use of bridging therapy after leukapheresis and before lymphodepleting chemotherapy is at the discretion of the treating physician
    Learn more about the safety profile from the ZUMA-1 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 16 days (from leukapheresis to product release).4‡‡

    ‡‡Data as of March 31, 2020.


    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-1 pivotal trial, patients received 500 mg/m2 intravenous (IV) cyclophosphamide and 30 mg/m2 IV fludarabine (–5, –4, and –3 days before infusion).3

    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-1 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).3 A single infusion of YESCARTA is administered to the patient at the YESCARTA Authorized Treatment Center in 30 minutes.

    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. For at least 4 weeks after infusion, the patient should stay within 2 hours of the YESCARTA Authorized Treatment Center.3

    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 large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

Limitation of Use: YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma.

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) occurred in 94% of patients, with 13%  Grade 3. Among patients who died after receiving YESCARTA, 4 had ongoing CRS at death. The median time to onset was 2 days (range: 1-12 days) and median duration was 7 days (range: 2-58 days). Key manifestations include fever (78%), hypotension (41%), tachycardia (28%), hypoxia (22%), and chills (20%). 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, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome. 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 occurred in 87% of patients, 98% of which occurred within the first 8 weeks with a median time to onset of 4 days (range: 1-43 days) and a median duration of 17 days. Grade 3 occurred in 31% of patients. The most common neurologic toxicities included encephalopathy (57%), headache (44%), tremor (31%), dizziness (21%), aphasia (18%), delirium (17%), insomnia (9%), and anxiety (9%). 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. 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 38% of patients. Grade 3 infections occurred in 23% of patients; those due to an unspecified pathogen occurred in 16% of patients, bacterial infections in 9%, and viral infections in 4%. 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 36% of patients 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. 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 28% of patients and included thrombocytopenia (18%), neutropenia (15%), and anemia (3%). Monitor blood counts after infusion.

HYPOGAMMAGLOBULINEMIA and B-cell aplasia can occur. Hypogammaglobulinemia occurred in 15% of patients. 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 (incidence 20%) include CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections-pathogen unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias.

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 large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

Limitation of Use: YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma.

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) occurred in 94% of patients, with 13%  Grade 3. Among patients who died after receiving YESCARTA, 4 had ongoing CRS at death. The median time to onset was 2 days (range: 1-12 days) and median duration was 7 days (range: 2-58 days). Key manifestations include fever (78%), hypotension (41%), tachycardia (28%), hypoxia (22%), and chills (20%). 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, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome. 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 occurred in 87% of patients, 98% of which occurred within the first 8 weeks with a median time to onset of 4 days (range: 1-43 days) and a median duration of 17 days. Grade 3 occurred in 31% of patients. The most common neurologic toxicities included encephalopathy (57%), headache (44%), tremor (31%), dizziness (21%), aphasia (18%), delirium (17%), insomnia (9%), and anxiety (9%). 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. 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 38% of patients. Grade 3 infections occurred in 23% of patients; those due to an unspecified pathogen occurred in 16% of patients, bacterial infections in 9%, and viral infections in 4%. 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 36% of patients 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. 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 28% of patients and included thrombocytopenia (18%), neutropenia (15%), and anemia (3%). Monitor blood counts after infusion.

HYPOGAMMAGLOBULINEMIA and B-cell aplasia can occur. Hypogammaglobulinemia occurred in 15% of patients. 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 (incidence 20%) include CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections-pathogen unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias.

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 large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

Limitation of Use: YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma.

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) occurred in 94% of patients, with 13%  Grade 3. Among patients who died after receiving YESCARTA, 4 had ongoing CRS at death. The median time to onset was 2 days (range: 1-12 days) and median duration was 7 days (range: 2-58 days). Key manifestations include fever (78%), hypotension (41%), tachycardia (28%), hypoxia (22%), and chills (20%). 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, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome. 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 occurred in 87% of patients, 98% of which occurred within the first 8 weeks with a median time to onset of 4 days (range: 1-43 days) and a median duration of 17 days. Grade 3 occurred in 31% of patients. The most common neurologic toxicities included encephalopathy (57%), headache (44%), tremor (31%), dizziness (21%), aphasia (18%), delirium (17%), insomnia (9%), and anxiety (9%). 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. 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 38% of patients. Grade 3 infections occurred in 23% of patients; those due to an unspecified pathogen occurred in 16% of patients, bacterial infections in 9%, and viral infections in 4%. 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 36% of patients 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. 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 28% of patients and included thrombocytopenia (18%), neutropenia (15%), and anemia (3%). Monitor blood counts after infusion.

HYPOGAMMAGLOBULINEMIA and B-cell aplasia can occur. Hypogammaglobulinemia occurred in 15% of patients. 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 (incidence 20%) include CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections-pathogen unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias.

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

References: 1. Data on file [1]. Kite Pharma, Inc; 2020. 2. Decision memo for chimeric antigen receptor (CAR) T-cell therapy for cancers (CAG-00451N). CMS.gov. Accessed January 31, 2020. https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=291 3. YESCARTA® (axicabtagene ciloleucel). Prescribing information. Kite Pharma, Inc; 2020. 4. Data on file [2]. Kite Pharma, Inc; 2020. 5. Data on file [3]. Kite Pharma, Inc; 2020. 6. Neelapu SS, Locke FL, Bartlett NL, et al. Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma. N Engl J Med. 2017;377(26):2531-2544. 7. Data on file [4]. Kite Pharma, Inc; 2020. 8. Locke FL, Ghobadi A, Jacobson CA, et al. Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1-2 trial. Lancet Oncol. 2019;20(1):31-42. 9. Locke FL, Ghobadi A, Jacobson CA, et al. Durability of response in ZUMA-1, the pivotal phase 2 study of axicabtagene ciloleucel (Axi-Cel) in patients (Pts) with refractory large B-cell lymphoma. Presented at: 2018 ASCO Annual Meeting; June 1-5, 2018; Chicago, IL. Abstract 3003. 10. Data on file [1]. Kite Pharma, Inc; 2019. 11. Neelapu SS, Rossi JM, Jacobson CA, et al. CD19-loss with preservation of other B cell lineage features in patients with large B cell lymphoma who relapsed post–axi-cel. Presented at: 61st ASH Annual Meeting and Exposition; December 7-10, 2019; Orlando, FL. Abstract 203. 12. Data on file [2]. Kite Pharma, Inc; 2019. 13. 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.