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LABELS · 49d73fc8-03e2-8b9c-e063-6294a90a3a97

MONJUVI

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
2026-02-02
Captured
2026-09-09T23:37:44.904352+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE MONJUVI, in combination with lenalidomide, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). MONJUVI is a CD19-directed cytolytic antibody indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. 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. BLA761163
boxed warning exact
    brand names
    1. MONJUVI
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ec13ac6b-bfde-4e84-907a-83bd69584d95
    generic names
    1. TAFASITAMAB-CXIX
    id
    49d73fc8-03e2-8b9c-e063-6294a90a3a97
    indications and usage exact
    1. 1 INDICATIONS AND USAGE MONJUVI, in combination with lenalidomide, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). MONJUVI is a CD19-directed cytolytic antibody indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. 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. Incyte Corporation
      matched search terms
      1. lymphoma
      package ndcs
      1. 73535-208-01
      product ndcs
      1. 73535-208
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVENOUS
        rxcuis
        1. 2387338
        2. 2387343
        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
        100
        skip
        200
        total
        830
        sha256
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        url
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        source url
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        spl effective date
        2026-02-02
        spl effective time
        20260202
        spl set id
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        spl version
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        substance names
        1. TAFASITAMAB
        uniis
        1. QQA9MLH692
        verification flags
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        2. spl_text_not_verified_identical_to_latest_approved_label
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        Drugs@FDA application source records
        1. application number
          BLA761163
          payload
          all indexed label documents
          1. Appl No
            761163
            Application Docs Date
            2020-07-31 00:00:00
            Application Docs ID
            64162
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            761163
            Application Docs Date
            2021-06-03 00:00:00
            Application Docs ID
            67688
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            SUPPL
          3. Appl No
            761163
            Application Docs Date
            2025-06-20 00:00:00
            Application Docs ID
            82614
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            13
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            761163
            Review Priority
            PRIORITY
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2020-07-31 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            761163
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2021-06-02 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            761163
            Review Priority
            PRIORITY
            Submission Class Code ID
            2
            Submission No
            13
            Submission Status
            AP
            Submission Status Date
            2025-06-18 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          BLA761163
          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
          2025-06-18
          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
            761163
            Application Docs Date
            2025-06-20 00:00:00
            Application Docs ID
            82614
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            13
            Submission Type
            SUPPL
          official application record
          Appl No
          761163
          Appl Public Notes
          Appl Type
          BLA
          Sponsor Name
          MORPHOSYS US INC
          openfda application present
          true
          products
          1. Active Ingredient
            TAFASITAMAB-CXIX
            Appl No
            761163
            Drug Name
            MONJUVI
            Form
            SOLUTION;INTRAVENOUS
            Product No
            001
            Reference Drug
            0
            Reference Standard
            0
            Strength
            12MG/KG
            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. BLA761163
        brand names
        1. MONJUVI
        classification reasons
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        clinical review status
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        content role
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        context span
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        524
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        true
        exact text
        1 INDICATIONS AND USAGE MONJUVI, in combination with lenalidomide, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and des
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        qualifier mentions
        1. context exact
          nation with lenalidomide, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (
          kind
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        3. context exact
          1 INDICATIONS AND USAGE MONJUVI, in combination with lenalidomide, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not
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          exact text
          in combination with lenalidomide, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, inclu
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          source defined aliases
          1. abbreviation
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            definition exact
            diffuse large B-cell lymphoma
            definition span
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            true
            exact text
            diffuse large B-cell lymphoma (DLBCL)
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          exact text
          1 INDICATIONS AND USAGE MONJUVI, in combination with lenalidomide, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).
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          source url
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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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          approval pathway
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          biomarker and test
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          disease stage
          Source null
          limitations
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          prior therapy
          Source null
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          tumor histology
          Source null
          use intent
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          Passage 2 · approval contingency
          application numbers
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          1. approval_contingency_words
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          exact text
          psed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). MONJUVI is a CD19-directed cytolytic antibody indicated in c
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          label id
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          positive predicate support span
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              This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14) ] .
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              ade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). MONJUVI is a CD19-directed cytolytic antibody indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not othe
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                  ased on overall response rate [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). MONJUVI is a CD19-directed cytolytic antibody indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit i
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                                Preserved source evidence · Not medical advice