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LABELS · 3916b425-789c-4223-bb91-1ee4b65ace41

POLIVY

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
2026-08-24
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 POLIVY is a CD79b-directed antibody and microtubule inhibitor conjugate indicated: in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index score of 2 or greater. ( 1.1 ) in combination with bendamustine and a rituximab product for the treatment of adult patients with relapsed or refractory DLBCL, NOS, after at least two prior therapies. ( 1.2 ) 1.1 Previously Untreated DLBCL, NOS or HGBL POLIVY in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) is indicated for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index score of 2 or greater. 1.2 Relapsed or Refractory DLBCL, NOS POLIVY in combination with bendamustine and a rituximab product is indicated for the treatment of adult patients with relapsed or refractory DLBCL, NOS, after at least two prior therapies.
Full extracted label fields
application numbers
  1. BLA761121
boxed warning exact
    brand names
    1. POLIVY
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=20a16ab2-f338-4abb-9dcd-254bd949a2bc
    generic names
    1. POLATUZUMAB VEDOTIN
    id
    3916b425-789c-4223-bb91-1ee4b65ace41
    indications and usage exact
    1. 1 INDICATIONS AND USAGE POLIVY is a CD79b-directed antibody and microtubule inhibitor conjugate indicated: in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index score of 2 or greater. ( 1.1 ) in combination with bendamustine and a rituximab product for the treatment of adult patients with relapsed or refractory DLBCL, NOS, after at least two prior therapies. ( 1.2 ) 1.1 Previously Untreated DLBCL, NOS or HGBL POLIVY in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) is indicated for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index score of 2 or greater. 1.2 Relapsed or Refractory DLBCL, NOS POLIVY in combination with bendamustine and a rituximab product is indicated for the treatment of adult patients with relapsed or refractory DLBCL, NOS, after at least two prior therapies.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Genentech, Inc.
      matched search terms
      1. lymphoma
      package ndcs
      1. 50242-105-01
      2. 50242-103-01
      product ndcs
      1. 50242-103
      2. 50242-105
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Dosage and Administration ( 2.4 ) 8/2026 Warnings and Precautions ( 5.8 ) 3/2026
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      rxcuis
      1. 2174095
      2. 2174100
      3. 2398131
      4. 2398133
      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
      d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
      url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=200&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%223916b425-789c-4223-bb91-1ee4b65ace41%22
      spl effective date
      2026-08-24
      spl effective time
      20260824
      spl set id
      20a16ab2-f338-4abb-9dcd-254bd949a2bc
      spl version
      15
      substance names
      1. POLATUZUMAB VEDOTIN
      uniis
      1. KG6VO684Z6
      verification flags
      1. oncology_keyword_candidate_not_clinically_classified
      2. spl_text_not_verified_identical_to_latest_approved_label
      3. individual_indications_not_split_or_reconciled
      Drugs@FDA application source records
      1. application number
        BLA761121
        payload
        all indexed label documents
        1. Appl No
          761121
          Application Docs Date
          2019-06-10 00:00:00
          Application Docs ID
          58998
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          761121
          Application Docs Date
          2021-01-12 00:00:00
          Application Docs ID
          65898
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        3. Appl No
          761121
          Application Docs Date
          2023-04-20 00:00:00
          Application Docs ID
          74031
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          8
          Submission Type
          SUPPL
        4. Appl No
          761121
          Application Docs Date
          2026-03-24 00:00:00
          Application Docs ID
          85483
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          17
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          761121
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2019-06-10 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          761121
          Review Priority
          N/A
          Submission Class Code ID
          4
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2020-09-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          761121
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          8
          Submission Status
          AP
          Submission Status Date
          2023-04-19 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          761121
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          17
          Submission Status
          AP
          Submission Status Date
          2026-03-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        BLA761121
        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
        2026-03-18
        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
          761121
          Application Docs Date
          2026-03-24 00:00:00
          Application Docs ID
          85483
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          17
          Submission Type
          SUPPL
        official application record
        Appl No
        761121
        Appl Public Notes
        Appl Type
        BLA
        Sponsor Name
        GENENTECH
        openfda application present
        true
        products
        1. Active Ingredient
          POLATUZUMAB VEDOTIN-PIIQ
          Appl No
          761121
          Drug Name
          POLIVY
          Form
          POWDER;INTRAVENOUS
          Product No
          001
          Reference Drug
          0
          Reference Standard
          0
          Strength
          140MG/VIAL
          marketing status
          1. Prescription
        2. Active Ingredient
          POLATUZUMAB VEDOTIN-PIIQ
          Appl No
          761121
          Drug Name
          POLIVY
          Form
          POWDER;INTRAVENOUS
          Product No
          002
          Reference Drug
          0
          Reference Standard
          0
          Strength
          30MG/VIAL
          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. BLA761121
      brand names
      1. POLIVY
      classification reasons
      1. explicit_positive_indication_predicate
      2. tumor_or_malignant_hematology_words_in_positive_statement
      clinical review status
      pending
      content role
      positive_indication_candidate
      context span
      end
      643
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE POLIVY is a CD79b-directed antibody and microtubule inhibitor conjugate indicated: in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index score of 2 or greater. ( 1.1 ) in combination with bendamustine and a rituximab product for the treatment of adult patients with relapsed or refractory DLBCL, NOS, after at least two prior therapies. ( 1.2 ) 1.1 Previously
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      duplicate text group
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      generic names
      1. POLATUZUMAB VEDOTIN
      id
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      exact text
      is a CD79b-directed antibody and microtubule inhibitor conjugate indicated
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      qualifier mentions
      1. context exact
        e, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma
        kind
        age
        polarity
        not_inferred
        span
        end
        237
        end exclusive
        true
        exact text
        adult patients
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      2. context exact
        nisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index score of 2 or greater.
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        end exclusive
        true
        exact text
        previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index score
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      3. context exact
        ted antibody and microtubule inhibitor conjugate indicated: in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-g
        kind
        regimen
        polarity
        not_inferred
        span
        end
        286
        end exclusive
        true
        exact text
        in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-ce
        label id
        3916b425-789c-4223-bb91-1ee4b65ace41
        offset unit
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        source field
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        source text sha256
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      regulatory links
        schema version
        0.1.0
        source batch sha256
        d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
        source defined aliases
        1. abbreviation
          DLBCL
          definition exact
          diffuse large B-cell lymphoma
          definition span
          end
          305
          end exclusive
          true
          exact text
          diffuse large B-cell lymphoma (DLBCL)
          label id
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        source span
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        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE POLIVY is a CD79b-directed antibody and microtubule inhibitor conjugate indicated: in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index score of 2 or greater.
        label id
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        offset unit
        unicode_code_points
        source array index
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        source field
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        source text sha256
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        source url
        https://api.fda.gov/drug/label.json?search=id%3A%223916b425-789c-4223-bb91-1ee4b65ace41%22
        spl effective date
        2026-08-24
        spl set id
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        spl version
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        structured fields status
        not_extracted_no_values_inferred_from_mentions
        structured indication
        age
        Source null
        approval pathway
        Source null
        biomarker and test
        Source null
        disease stage
        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 · unclassified context
        application numbers
        1. BLA761121
        brand names
        1. POLIVY
        classification reasons
        1. no_unambiguous_positive_indication_predicate
        clinical review status
        pending
        content role
        unclassified_context
        context span
        end
        651
        end exclusive
        true
        exact text
        ve previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index score of 2 or greater. ( 1.1 ) in combination with bendamustine and a rituximab product for the treatment of adult patients with relapsed or refractory DLBCL, NOS, after at least two prior therapies. ( 1.2 ) 1.1 Previously Untreat
        label id
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        current approval status
        not_reconciled
        duplicate text group
        dup-55001aa7d0edcb32efeb
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. POLATUZUMAB VEDOTIN
        id
        ind-span-2828249c28672d47846c
        label id
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        positive predicate support span
        Source null
        qualifier mentions
          regulatory links
            schema version
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            source batch sha256
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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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              end exclusive
              true
              exact text
              diffuse large B-cell lymphoma (DLBCL)
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            ( 1.1 )
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            source url
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            spl effective date
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            limitations
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            tumor histology
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            unclear
            Passage 3 · positive indication candidate
            application numbers
            1. BLA761121
            brand names
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            classification reasons
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            clinical review status
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            context span
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            820
            end exclusive
            true
            exact text
            ously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index score of 2 or greater. ( 1.1 ) in combination with bendamustine and a rituximab product for the treatment of adult patients with relapsed or refractory DLBCL, NOS, after at least two prior therapies. ( 1.2 ) 1.1 Previously Untreated DLBCL, NOS or HGBL POLIVY in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) is indicated for the treatment of adult patie
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            current approval status
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            duplicate text group
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            generic names
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            exact text
            is a CD79b-directed antibody and microtubule inhibitor conjugate indicated
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            qualifier mentions
            1. context exact
              h bendamustine and a rituximab product for the treatment of adult patients with relapsed or refractory DLBCL, NOS, after at least two
              kind
              age
              polarity
              not_inferred
              span
              end
              544
              end exclusive
              true
              exact text
              adult patients
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              offset unit
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            2. context exact
              rituximab product for the treatment of adult patients with relapsed or refractory DLBCL, NOS, after at least two prior therapies.
              kind
              stage_or_setting
              polarity
              not_inferred
              span
              end
              578
              end exclusive
              true
              exact text
              relapsed or refractory DLBCL
              label id
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            3. context exact
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                      Preserved source evidence · Not medical advice