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LABELS · a70f85e0-c22b-419a-9be2-51f575932633

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
2025-06-23
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE 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). ( 1.1 ) in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). ( 1.2 ) Limitations of Use : MONJUVI is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials. ( 1.2 , 14.3 ) 1.1 Relapsed or Refractory Diffuse Large B-cell Lymphoma 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 ( 14.1 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.2 Relapsed or Refractory Follicular Lymphoma MONJUVI, in combination with lenalidomide and rituximab, is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Limitations of Use : MONJUVI is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials [see Clinical Studies ( 14.3 )].
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=9e0a220b-517f-4c86-b581-ffbab493fb58
    generic names
    1. TAFASITAMAB-CXIX
    id
    a70f85e0-c22b-419a-9be2-51f575932633
    indications and usage exact
    1. 1 INDICATIONS AND USAGE 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). ( 1.1 ) in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). ( 1.2 ) Limitations of Use : MONJUVI is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials. ( 1.2 , 14.3 ) 1.1 Relapsed or Refractory Diffuse Large B-cell Lymphoma 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 ( 14.1 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.2 Relapsed or Refractory Follicular Lymphoma MONJUVI, in combination with lenalidomide and rituximab, is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Limitations of Use : MONJUVI is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials [see Clinical Studies ( 14.3 )].
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Incyte Corporation
      matched search terms
      1. lymphoma
      package ndcs
      1. 50881-013-03
      product ndcs
      1. 50881-013
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Indications and Usage, Relapsed or Refractory Follicular Lymphoma ( 1.2 ) 6/2025 Dosage and Administration, Recommended Dosage for Relapsed or Refractory Follicular Lymphoma ( 2.3 ) 6/2025 Dosage and Administration, Recommended Premedications and Prophylactic Medication ( 2.4 ) 6/2025 Warnings and Precautions, Infusion-Related Reactions ( 5.1 ) 6/2025 Warnings and Precautions, Myelosuppression ( 5.2 ) 6/2025 Warnings and Precautions, Infections ( 5.3 ) 6/2025
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      1. INTRAVENOUS
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      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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      url
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      spl effective date
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      spl effective time
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      substance names
      1. TAFASITAMAB
      uniis
      1. QQA9MLH692
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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
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          0
          Application Docs Type ID
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          761163
          Application Docs Date
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          Application Docs ID
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        3. Appl No
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          Application Docs ID
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          0
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          Submission No
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        1. Appl No
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          PRIORITY
          Submission Class Code ID
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          Submission Status Date
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        2. Appl No
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          STANDARD
          Submission Class Code ID
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          Submission No
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          Submission Status Date
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          Submissions Public Notes
        3. Appl No
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          Submission Status Date
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          Submission Type
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          Submissions Public Notes
        application number
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        has approved submission record
        true
        latest approved submission date
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        latest posted label documents
        1. Appl No
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          Application Docs Date
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          Application Docs ID
          82614
          Application Docs Title
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          Application Docs Type ID
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          Submission No
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          Submission Type
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        official application record
        Appl No
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        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
      1. explicit_positive_indication_predicate
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      clinical review status
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      content role
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      558
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      true
      exact text
      1 INDICATIONS AND USAGE 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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      is a CD19-directed cytolytic antibody indicated
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        ated: in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (
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      2. context exact
        1 INDICATIONS AND USAGE MONJUVI is a CD19-directed cytolytic antibody indicated: in combination with lenalidomide for the treatment of adult
        kind
        biomarker
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        span
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        end exclusive
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        exact text
        CD19-directed cytolytic antibody indicated:
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      4. context exact
        GE 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 a
        kind
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        exact text
        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 ari
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      regulatory links
      1. candidate source span
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        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE 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).
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        fda indication exact
        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).
        fda source row index
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          definition exact
          diffuse large B-cell lymphoma
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        exact text
        1 INDICATIONS AND USAGE 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).
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        spl effective date
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        Read indication-specific status → · whole_fda_indication_text_present

        Passage 2 · approval contingency
        application numbers
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        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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.1 ) in combination with lenalidomide and rituximab for t
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              exact text
              diffuse large B-cell lymphoma (DLBCL)
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                                        1.2 Relapsed or Refractory Follicular Lymphoma MONJUVI, in combination with lenalidomide and rituximab, is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).
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                                        apsed or Refractory Follicular Lymphoma MONJUVI, in combination with lenalidomide and rituximab, is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Limitations of Use : MONJUVI is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials [see Clinical Studies ( 14.3 )].
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                                          Limitations of Use : MONJUVI is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials [see Clinical Studies ( 14.3 )].
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                                          Preserved source evidence · Not medical advice