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LABELS · 5900ea09-1687-4d73-912f-5b0527cba6be

TECVAYLI

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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2026-03-10
Captured
2026-09-09T23:37:47.659725+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY, including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Initiate treatment with TECVAYLI step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 , 2.5) and Warnings and Precautions (5.1) ] . Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious, life-threatening, or fatal reactions, can occur in patients receiving TECVAYLI. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI until neurologic toxicity resolves or permanently discontinue based on severity [see Dosage and Administration (2.5) and Warnings and Precautions (5.2) ] . Because of the risk of CRS and neurologic toxicity, including ICANS, TECVAYLI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TECVAYLI and TALVEY REMS [see Warnings and Precautions (5.3) ] . WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME See full prescribing information for complete boxed warning. Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Initiate treatment with TECVAYLI step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI until CRS resolves or permanently discontinue based on severity. ( 2.1 , 2.5 , 5.1 ) Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious, life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI until neurologic toxicity resolves or permanently discontinue based on severity. ( 2.5 , 5.2 ) TECVAYLI is available only through a restricted program called the TECVAYLI and TALVEY Risk Evaluation and Mitigation Strategy (REMS). ( 5.3 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE TECVAYLI is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma in combination with daratumumab and hyaluronidase-fihj in patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. as monotherapy, in patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. TECVAYLI is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma: in combination with daratumumab and hyaluronidase-fihj in patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent ( 1 ). as monotherapy, in patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody ( 1 ).
Full extracted label fields
application numbers
  1. BLA761291
boxed warning exact
  1. WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY, including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Initiate treatment with TECVAYLI step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 , 2.5) and Warnings and Precautions (5.1) ] . Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious, life-threatening, or fatal reactions, can occur in patients receiving TECVAYLI. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI until neurologic toxicity resolves or permanently discontinue based on severity [see Dosage and Administration (2.5) and Warnings and Precautions (5.2) ] . Because of the risk of CRS and neurologic toxicity, including ICANS, TECVAYLI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TECVAYLI and TALVEY REMS [see Warnings and Precautions (5.3) ] . WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME See full prescribing information for complete boxed warning. Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Initiate treatment with TECVAYLI step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI until CRS resolves or permanently discontinue based on severity. ( 2.1 , 2.5 , 5.1 ) Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious, life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI until neurologic toxicity resolves or permanently discontinue based on severity. ( 2.5 , 5.2 ) TECVAYLI is available only through a restricted program called the TECVAYLI and TALVEY Risk Evaluation and Mitigation Strategy (REMS). ( 5.3 )
brand names
  1. TECVAYLI
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54e0f974-ccee-44ea-9254-40e9883cee1e
generic names
  1. TECLISTAMAB-CQYV
id
5900ea09-1687-4d73-912f-5b0527cba6be
indications and usage exact
  1. 1 INDICATIONS AND USAGE TECVAYLI is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma in combination with daratumumab and hyaluronidase-fihj in patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. as monotherapy, in patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. TECVAYLI is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma: in combination with daratumumab and hyaluronidase-fihj in patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent ( 1 ). as monotherapy, in patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody ( 1 ).
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Janssen Biotech, Inc.
    matched search terms
    1. myeloma
    package ndcs
    1. 57894-449-01
    2. 57894-450-01
    product ndcs
    1. 57894-449
    2. 57894-450
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Boxed Warnings 8/2025 Indications and Usage ( 1 ) 3/2026 Dosage and Administration ( 2.1 , 2.2 , 2.4 , 2.5 , 2.6 ) 3/2026 Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 , 5.5 , 5.6 , 5.7 ) 3/2026
    record type
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    1. SUBCUTANEOUS
    rxcuis
    1. 2619432
    2. 2619438
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    4. 2619444
    source batch
    file
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    meta
    disclaimer
    Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
    last updated
    2026-09-09
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    sha256
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    url
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    source url
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    spl effective date
    2026-03-10
    spl effective time
    20260310
    spl set id
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    spl version
    16
    substance names
    1. TECLISTAMAB
    uniis
    1. 54534MX6Z9
    verification flags
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    Drugs@FDA application source records
    1. application number
      BLA761291
      payload
      all indexed label documents
      1. Appl No
        761291
        Application Docs Date
        2022-10-26 00:00:00
        Application Docs ID
        72465
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        ORIG
      2. Appl No
        761291
        Application Docs Date
        2023-08-10 00:00:00
        Application Docs ID
        75038
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        4
        Submission Type
        SUPPL
      3. Appl No
        761291
        Application Docs Date
        2024-02-21 00:00:00
        Application Docs ID
        77591
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        3
        Submission Type
        SUPPL
      4. Appl No
        761291
        Application Docs Date
        2024-05-30 00:00:00
        Application Docs ID
        78585
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        8
        Submission Type
        SUPPL
      5. Appl No
        761291
        Application Docs Date
        2025-08-21 00:00:00
        Application Docs ID
        83164
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        13
        Submission Type
        SUPPL
      6. Appl No
        761291
        Application Docs Date
        2026-03-12 00:00:00
        Application Docs ID
        85345
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        18
        Submission Type
        SUPPL
      all submission records
      1. Appl No
        761291
        Review Priority
        PRIORITY
        Submission Class Code ID
        2
        Submission No
        18
        Submission Status
        AP
        Submission Status Date
        2026-03-05 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      2. Appl No
        761291
        Review Priority
        N/A
        Submission Class Code ID
        21
        Submission No
        17
        Submission Status
        AP
        Submission Status Date
        2026-05-06 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      3. Appl No
        761291
        Review Priority
        N/A
        Submission Class Code ID
        21
        Submission No
        15
        Submission Status
        AP
        Submission Status Date
        2025-10-02 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      4. Appl No
        761291
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        13
        Submission Status
        AP
        Submission Status Date
        2025-08-19 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      5. Appl No
        761291
        Review Priority
        N/A
        Submission Class Code ID
        21
        Submission No
        11
        Submission Status
        AP
        Submission Status Date
        2024-12-02 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      6. Appl No
        761291
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        9
        Submission Status
        AP
        Submission Status Date
        2024-11-22 00:00:00
        Submission Type
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        Submissions Public Notes
      7. Appl No
        761291
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        8
        Submission Status
        AP
        Submission Status Date
        2024-05-28 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      8. Appl No
        761291
        Review Priority
        N/A
        Submission Class Code ID
        21
        Submission No
        7
        Submission Status
        AP
        Submission Status Date
        2024-07-02 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      9. Appl No
        761291
        Review Priority
        N/A
        Submission Class Code ID
        21
        Submission No
        5
        Submission Status
        AP
        Submission Status Date
        2023-11-16 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      10. Appl No
        761291
        Review Priority
        N/A
        Submission Class Code ID
        21
        Submission No
        4
        Submission Status
        AP
        Submission Status Date
        2023-08-09 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      11. Appl No
        761291
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        3
        Submission Status
        AP
        Submission Status Date
        2024-02-20 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      12. Appl No
        761291
        Review Priority
        PRIORITY
        Submission Class Code ID
        7
        Submission No
        1
        Submission Status
        AP
        Submission Status Date
        2022-10-25 00:00:00
        Submission Type
        ORIG
        Submissions Public Notes
      application number
      BLA761291
      approval interpretation
      Application linkage and approved submission are not indication-level current approval verification
      current indication status
      not_reconciled
      has approved submission record
      true
      latest approved submission date
      2026-05-06
      latest label selection rule
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      latest posted label documents
      1. Appl No
        761291
        Application Docs Date
        2026-03-12 00:00:00
        Application Docs ID
        85345
        Application Docs Title
        0
        Application Docs Type ID
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        Submission No
        18
        Submission Type
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      official application record
      Appl No
      761291
      Appl Public Notes
      Appl Type
      BLA
      Sponsor Name
      JANSSEN BIOTECH
      openfda application present
      true
      products
      1. Active Ingredient
        TECLISTAMAB-CQYV
        Appl No
        761291
        Drug Name
        TECVAYLI
        Form
        INJECTABLE;INJECTION
        Product No
        001
        Reference Drug
        0
        Reference Standard
        0
        Strength
        30MG/3ML(10MG/ML)
        marketing status
        1. Prescription
      2. Active Ingredient
        TECLISTAMAB-CQYV
        Appl No
        761291
        Drug Name
        TECVAYLI
        Form
        INJECTABLE;INJECTION
        Product No
        002
        Reference Drug
        0
        Reference Standard
        0
        Strength
        153MG/1.7ML(90MG/ML)
        marketing status
        1. Prescription

    Source passages and status connections

    Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

    Passage 1 · positive indication candidate
    application numbers
    1. BLA761291
    brand names
    1. TECVAYLI
    classification reasons
    1. explicit_positive_indication_predicate
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    clinical review status
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    content role
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    exact text
    1 INDICATIONS AND USAGE TECVAYLI is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma in combination with daratumumab and hyaluronidase-fihj in patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. as monotherapy, in patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. TECVAYLI is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma: in combination with d
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    generic names
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    1. context exact
      ATIONS AND USAGE TECVAYLI is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma in combination
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      not_inferred
      span
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    3. context exact
      VAYLI is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma in combination with daratumumab and hyaluronidase-fihj in patie
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    4. context exact
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    6. context exact
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            Preserved source evidence · Not medical advice