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LABELS · 33693fc1-cb24-4ce6-8ceb-b34ebf3536c0

Columvi

Open original source → · Download preserved record

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
2026-06-25
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: CYTOKINE RELEASE SYNDROME Cytokine Release Syndrome (CRS), including serious or fatal reactions, can occur in patients receiving COLUMVI. Premedicate before each dose, and initiate treatment with the COLUMVI step-up dosing schedule to reduce the risk of CRS. Withhold COLUMVI until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 , 2.2 , 2.3 , and 2.4) and Warnings and Precautions (5.1) ] . WARNING: CYTOKINE RELEASE SYNDROME See full prescribing information for complete boxed warning Cytokine Release Syndrome (CRS), including serious or fatal reactions, can occur in patients receiving COLUMVI. Premedicate before each dose, and initiate treatment with the COLUMVI step-up dosing schedule to reduce the risk of CRS. Withhold COLUMVI until CRS resolves or permanently discontinue based on severity. ( 2.1 , 2.2 , 2.3 , 2.4 , 5.1 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE COLUMVI is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). COLUMVI is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )
Full extracted label fields
application numbers
  1. BLA761309
boxed warning exact
  1. WARNING: CYTOKINE RELEASE SYNDROME Cytokine Release Syndrome (CRS), including serious or fatal reactions, can occur in patients receiving COLUMVI. Premedicate before each dose, and initiate treatment with the COLUMVI step-up dosing schedule to reduce the risk of CRS. Withhold COLUMVI until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 , 2.2 , 2.3 , and 2.4) and Warnings and Precautions (5.1) ] . WARNING: CYTOKINE RELEASE SYNDROME See full prescribing information for complete boxed warning Cytokine Release Syndrome (CRS), including serious or fatal reactions, can occur in patients receiving COLUMVI. Premedicate before each dose, and initiate treatment with the COLUMVI step-up dosing schedule to reduce the risk of CRS. Withhold COLUMVI until CRS resolves or permanently discontinue based on severity. ( 2.1 , 2.2 , 2.3 , 2.4 , 5.1 )
brand names
  1. Columvi
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3516e753-f064-4d30-9bd5-e3f2e143f75d
generic names
  1. GLOFITAMAB
id
33693fc1-cb24-4ce6-8ceb-b34ebf3536c0
indications and usage exact
  1. 1 INDICATIONS AND USAGE COLUMVI is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). COLUMVI is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Genentech, Inc.
    matched search terms
    1. lymphoma
    package ndcs
    1. 50242-127-01
    2. 50242-125-01
    product ndcs
    1. 50242-125
    2. 50242-127
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Dosage and Administration ( 2.1 , 2.3 , 2.5 , 2.6 , 2.7 ) 10/2025 Warnings and Precautions ( 5.1 ) 5/2026 Warnings and Precautions ( 5.3 ) 6/2026
    record type
    complete_spl_indications_section_candidate
    routes
    1. INTRAVENOUS
    rxcuis
    1. 2639786
    2. 2639792
    3. 2639794
    4. 2639795
    source batch
    file
    /private/tmp/cancer-full-research/indications/raw/labels-00100.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
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    total
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    sha256
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    url
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    source url
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    spl effective date
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    spl effective time
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    spl set id
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    spl version
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    substance names
    1. GLOFITAMAB
    uniis
    1. 06P3KLK2J8
    verification flags
    1. oncology_keyword_candidate_not_clinically_classified
    2. spl_text_not_verified_identical_to_latest_approved_label
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    Drugs@FDA application source records
    1. application number
      BLA761309
      payload
      all indexed label documents
      1. Appl No
        761309
        Application Docs Date
        2023-06-16 00:00:00
        Application Docs ID
        74501
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        ORIG
      2. Appl No
        761309
        Application Docs Date
        2025-06-10 00:00:00
        Application Docs ID
        82529
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        3
        Submission Type
        SUPPL
      3. Appl No
        761309
        Application Docs Date
        2025-10-28 00:00:00
        Application Docs ID
        83940
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        4
        Submission Type
        SUPPL
      4. Appl No
        761309
        Application Docs Date
        2026-06-01 00:00:00
        Application Docs ID
        86090
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        6
        Submission Type
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      5. Appl No
        761309
        Application Docs Date
        2026-06-23 00:00:00
        Application Docs ID
        86342
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        7
        Submission Type
        SUPPL
      all submission records
      1. Appl No
        761309
        Review Priority
        PRIORITY
        Submission Class Code ID
        7
        Submission No
        1
        Submission Status
        AP
        Submission Status Date
        2023-06-15 00:00:00
        Submission Type
        ORIG
        Submissions Public Notes
      2. Appl No
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        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        3
        Submission Status
        AP
        Submission Status Date
        2025-06-09 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      3. Appl No
        761309
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        4
        Submission Status
        AP
        Submission Status Date
        2025-10-27 00:00:00
        Submission Type
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        Submissions Public Notes
      4. Appl No
        761309
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        6
        Submission Status
        AP
        Submission Status Date
        2026-05-28 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      5. Appl No
        761309
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        7
        Submission Status
        AP
        Submission Status Date
        2026-06-22 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      application number
      BLA761309
      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
      2026-06-22
      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
        761309
        Application Docs Date
        2026-06-23 00:00:00
        Application Docs ID
        86342
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        7
        Submission Type
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      official application record
      Appl No
      761309
      Appl Public Notes
      Appl Type
      BLA
      Sponsor Name
      GENENTECH INC
      openfda application present
      true
      products
      1. Active Ingredient
        GLOFITAMAB-GXBM
        Appl No
        761309
        Drug Name
        COLUMVI
        Form
        INJECTABLE;INJECTION
        Product No
        001
        Reference Drug
        0
        Reference Standard
        0
        Strength
        2.5MG/2.5ML(1MG/ML)
        marketing status
        1. Prescription
      2. Active Ingredient
        GLOFITAMAB-GXBM
        Appl No
        761309
        Drug Name
        COLUMVI
        Form
        INJECTABLE;INJECTION
        Product No
        002
        Reference Drug
        0
        Reference Standard
        0
        Strength
        10MG/10ML(1MG/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. BLA761309
    brand names
    1. Columvi
    classification reasons
    1. explicit_positive_indication_predicate
    2. tumor_or_malignant_hematology_words_in_positive_statement
    clinical review status
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    content role
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    487
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    true
    exact text
    1 INDICATIONS AND USAGE COLUMVI is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon
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    qualifier mentions
    1. context exact
      CATIONS AND USAGE COLUMVI is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma,
      kind
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    2. context exact
      LUMVI is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-c
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      not_inferred
      span
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      exact text
      relapsed or refractory diffuse large B-cell
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        true
        exact text
        1 INDICATIONS AND USAGE COLUMVI is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy.
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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
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        Source null
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        Passage 2 · approval contingency
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        true
        exact text
        lapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). COLUMVI is a bispecific CD20-directed CD3 T-cell engager ind
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              This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14.1) ] .
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              source url
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              Source null
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              Source null
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              Passage 3 · approval contingency
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              icular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). COLUMVI is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS)
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                    Passage 4 · positive indication candidate
                    application numbers
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                    exact text
                    and durability of response [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). COLUMVI is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of
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                                          Preserved source evidence · Not medical advice