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LABELS · 47afa519-4a05-4ac2-8604-437371837128

Gazyva

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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
2025-12-19
Captured
2026-09-09T23:37:44.904352+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients receiving CD20-directed cytolytic antibodies, including GAZYVA. Screen all patients for HBV infection before treatment initiation. Monitor HBV-positive patients during and after treatment with GAZYVA. Discontinue GAZYVA and concomitant medications in the event of HBV reactivation [see Warnings and Precautions (5.1) ] . Progressive Multifocal Leukoencephalopathy (PML) including fatal PML, can occur in patients receiving GAZYVA [see Warnings and Precautions (5.2) ] . WARNING: HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning. Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death. ( 5.1 ) Progressive Multifocal Leukoencephalopathy (PML) resulting in death. ( 5.2 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE GAZYVA is a CD20-directed cytolytic antibody indicated: in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). ( 1.1 , 14 ) in combination with bendamustine followed by GAZYVA monotherapy, for the treatment of patients with follicular lymphoma (FL)who relapsed after, or are refractory to, a rituximab-containing regimen. ( 1.2 , 14 ) in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma. ( 1.2 , 14 ) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy ( 1.3 , 14 ) 1.1 Chronic Lymphocytic Leukemia (CLL) GAZYVA, in combination with chlorambucil, is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia. 1.2 Follicular Lymphoma (FL) GAZYVA, in combination with bendamustine followed by GAZYVA monotherapy, is indicated for the treatment of patients with follicular lymphoma who relapsed after, or are refractory to, a rituximab-containing regimen . GAZYVA, in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission, is indicated for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma . 1.3 Lupus Nephritis (LN) GAZYVA is indicated for the treatment of adult patients with active lupus nephritis who are receiving standard therapy.
Full extracted label fields
application numbers
  1. BLA125486
boxed warning exact
  1. WARNING: HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients receiving CD20-directed cytolytic antibodies, including GAZYVA. Screen all patients for HBV infection before treatment initiation. Monitor HBV-positive patients during and after treatment with GAZYVA. Discontinue GAZYVA and concomitant medications in the event of HBV reactivation [see Warnings and Precautions (5.1) ] . Progressive Multifocal Leukoencephalopathy (PML) including fatal PML, can occur in patients receiving GAZYVA [see Warnings and Precautions (5.2) ] . WARNING: HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning. Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death. ( 5.1 ) Progressive Multifocal Leukoencephalopathy (PML) resulting in death. ( 5.2 )
brand names
  1. Gazyva
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df12ceb2-5b4b-4ab5-a317-2a36bf2a3cda
generic names
  1. OBINUTUZUMAB
id
47afa519-4a05-4ac2-8604-437371837128
indications and usage exact
  1. 1 INDICATIONS AND USAGE GAZYVA is a CD20-directed cytolytic antibody indicated: in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). ( 1.1 , 14 ) in combination with bendamustine followed by GAZYVA monotherapy, for the treatment of patients with follicular lymphoma (FL)who relapsed after, or are refractory to, a rituximab-containing regimen. ( 1.2 , 14 ) in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma. ( 1.2 , 14 ) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy ( 1.3 , 14 ) 1.1 Chronic Lymphocytic Leukemia (CLL) GAZYVA, in combination with chlorambucil, is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia. 1.2 Follicular Lymphoma (FL) GAZYVA, in combination with bendamustine followed by GAZYVA monotherapy, is indicated for the treatment of patients with follicular lymphoma who relapsed after, or are refractory to, a rituximab-containing regimen . GAZYVA, in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission, is indicated for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma . 1.3 Lupus Nephritis (LN) GAZYVA is indicated for the treatment of adult patients with active lupus nephritis who are receiving standard therapy.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Genentech, Inc.
    matched search terms
    1. lymphoma
    2. leukemia
    package ndcs
    1. 50242-070-01
    2. 50242-070-86
    product ndcs
    1. 50242-070
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Indication and Usage, Lupus Nephritis ( 1.3 ) 10/2025 Dosage and Administration ( 2.4 ) 10/2025 Warnings and Precautions ( 5 ) 10/2025
    record type
    complete_spl_indications_section_candidate
    routes
    1. INTRAVENOUS
    rxcuis
    1. 1442693
    2. 1442698
    source batch
    file
    /private/tmp/cancer-full-research/indications/raw/labels-00200.json
    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
    results
    limit
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    skip
    200
    total
    830
    sha256
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    url
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    source url
    https://api.fda.gov/drug/label.json?search=id%3A%2247afa519-4a05-4ac2-8604-437371837128%22
    spl effective date
    2025-12-19
    spl effective time
    20251219
    spl set id
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    spl version
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    substance names
    1. OBINUTUZUMAB
    uniis
    1. O43472U9X8
    verification flags
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    Drugs@FDA application source records
    1. application number
      BLA125486
      payload
      all indexed label documents
      1. Appl No
        125486
        Application Docs Date
        2013-11-01 00:00:00
        Application Docs ID
        18921
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        ORIG
      2. Appl No
        125486
        Application Docs Date
        2015-10-06 00:00:00
        Application Docs ID
        18922
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        10
        Submission Type
        SUPPL
      3. Appl No
        125486
        Application Docs Date
        2014-07-01 00:00:00
        Application Docs ID
        39976
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        8
        Submission Type
        SUPPL
      4. Appl No
        125486
        Application Docs Date
        2016-02-26 00:00:00
        Application Docs ID
        39977
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        13
        Submission Type
        SUPPL
      5. Appl No
        125486
        Application Docs Date
        2017-11-16 00:00:00
        Application Docs ID
        50433
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        18
        Submission Type
        SUPPL
      6. Appl No
        125486
        Application Docs Date
        2017-11-16 00:00:00
        Application Docs ID
        50434
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        17
        Submission Type
        SUPPL
      7. Appl No
        125486
        Application Docs Date
        2020-03-30 00:00:00
        Application Docs ID
        62366
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        25
        Submission Type
        SUPPL
      8. Appl No
        125486
        Application Docs Date
        2022-02-15 00:00:00
        Application Docs ID
        70173
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        29
        Submission Type
        SUPPL
      9. Appl No
        125486
        Application Docs Date
        2022-07-15 00:00:00
        Application Docs ID
        71562
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        33
        Submission Type
        SUPPL
      10. Appl No
        125486
        Application Docs Date
        2022-07-28 00:00:00
        Application Docs ID
        71658
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        34
        Submission Type
        SUPPL
      11. Appl No
        125486
        Application Docs Date
        2025-10-20 00:00:00
        Application Docs ID
        83821
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        38
        Submission Type
        SUPPL
      12. Appl No
        125486
        Application Docs Date
        2025-10-20 00:00:00
        Application Docs ID
        83822
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        37
        Submission Type
        SUPPL
      all submission records
      1. Appl No
        125486
        Review Priority
        PRIORITY
        Submission Class Code ID
        7
        Submission No
        1
        Submission Status
        AP
        Submission Status Date
        2013-11-01 00:00:00
        Submission Type
        ORIG
        Submissions Public Notes
      2. Appl No
        125486
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        8
        Submission Status
        AP
        Submission Status Date
        2014-06-27 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      3. Appl No
        125486
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        9
        Submission Status
        AP
        Submission Status Date
        2014-12-24 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      4. Appl No
        125486
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        10
        Submission Status
        AP
        Submission Status Date
        2015-09-23 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      5. Appl No
        125486
        Review Priority
        PRIORITY
        Submission Class Code ID
        2
        Submission No
        13
        Submission Status
        AP
        Submission Status Date
        2016-02-26 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      6. Appl No
        125486
        Review Priority
        PRIORITY
        Submission Class Code ID
        2
        Submission No
        17
        Submission Status
        AP
        Submission Status Date
        2017-11-16 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      7. Appl No
        125486
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        18
        Submission Status
        AP
        Submission Status Date
        2017-11-16 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      8. Appl No
        125486
        Review Priority
        PRIORITY
        Submission Class Code ID
        2
        Submission No
        25
        Submission Status
        AP
        Submission Status Date
        2020-03-27 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      9. Appl No
        125486
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        29
        Submission Status
        AP
        Submission Status Date
        2022-02-14 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      10. Appl No
        125486
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        33
        Submission Status
        AP
        Submission Status Date
        2022-07-12 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      11. Appl No
        125486
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        34
        Submission Status
        AP
        Submission Status Date
        2022-07-27 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      12. Appl No
        125486
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        37
        Submission Status
        AP
        Submission Status Date
        2025-10-17 00:00:00
        Submission Type
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        Submissions Public Notes
      application number
      BLA125486
      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
      2025-12-17
      latest label selection rule
      max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
      latest posted label documents
      1. Appl No
        125486
        Application Docs Date
        2025-12-22 00:00:00
        Application Docs ID
        84482
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        40
        Submission Type
        SUPPL
      official application record
      Appl No
      125486
      Appl Public Notes
      Appl Type
      BLA
      Sponsor Name
      GENENTECH
      openfda application present
      true
      products
      1. Active Ingredient
        OBINUTUZUMAB
        Appl No
        125486
        Drug Name
        GAZYVA
        Form
        INJECTABLE;INJECTION
        Product No
        001
        Reference Drug
        0
        Reference Standard
        Strength
        1000MG/40ML
        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. BLA125486
    brand names
    1. Gazyva
    classification reasons
    1. explicit_positive_indication_predicate
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    clinical review status
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    context span
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    405
    end exclusive
    true
    exact text
    1 INDICATIONS AND USAGE GAZYVA is a CD20-directed cytolytic antibody indicated: in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). ( 1.1 , 14 ) in combination with bendamustine followed by GAZYVA monotherapy, for the treatment of patients with follicular lymphoma (FL)who relapsed after, or are refractory to, a rituximab-containi
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    positive predicate support span
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    is a CD20-directed cytolytic antibody indicated
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    1. context exact
      1 INDICATIONS AND USAGE GAZYVA is a CD20-directed cytolytic antibody indicated: in combination with chlorambucil, for the treatment of patie
      kind
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      polarity
      not_inferred
      span
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      end exclusive
      true
      exact text
      CD20-directed cytolytic antibody indicated:
      label id
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      ation with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).
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      previously untreated chronic lymphocytic leukemia (CLL)
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    3. context exact
      AGE GAZYVA is a CD20-directed cytolytic antibody indicated: in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).
      kind
      regimen
      polarity
      not_inferred
      span
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      exact text
      in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL)
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    regulatory links
      schema version
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      source batch sha256
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      source defined aliases
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        definition exact
        follicular lymphoma
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        follicular lymphoma (FL)
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      1 INDICATIONS AND USAGE GAZYVA is a CD20-directed cytolytic antibody indicated: in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).
      label id
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      spl effective date
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      spl set id
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      structured fields status
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      Source null
      approval pathway
      Source null
      biomarker and test
      Source null
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      Source null
      limitations
      Source null
      line
      Source null
      prior therapy
      Source null
      regimen
      Source null
      tumor histology
      Source null
      use intent
      tumor_directed_candidate
      Passage 2 · positive indication candidate
      application numbers
      1. BLA125486
      brand names
      1. Gazyva
      classification reasons
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      exact text
      CATIONS AND USAGE GAZYVA is a CD20-directed cytolytic antibody indicated: in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). ( 1.1 , 14 ) in combination with bendamustine followed by GAZYVA monotherapy, for the treatment of patients with follicular lymphoma (FL)who relapsed after, or are refractory to, a rituximab-containing regimen. ( 1.2 , 14 ) in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II
      label id
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      positive predicate support span
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      exact text
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