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LABELS · caa201eb-143f-4390-9788-894e1810fee8

JUBEREQ

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
2026-07-14
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Jubereq is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Jubereq is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. 1.2 Giant Cell Tumor of Bone Jubereq is indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity [see Clinical Trials ( 14.2 )] . 1.3 Hypercalcemia of Malignancy Jubereq is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
Full extracted label fields
application numbers
  1. BLA761424
boxed warning exact
    brand names
    1. JUBEREQ
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e15dfe74-1575-4a2a-895e-323c05613362
    generic names
    1. DENOSUMAB-DESU
    id
    caa201eb-143f-4390-9788-894e1810fee8
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Jubereq is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Jubereq is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. 1.2 Giant Cell Tumor of Bone Jubereq is indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity [see Clinical Trials ( 14.2 )] . 1.3 Hypercalcemia of Malignancy Jubereq is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Accord BioPharma Inc.
      matched search terms
      1. myeloma
      2. tumor
      3. tumors
      4. malignancy
      package ndcs
      1. 69448-022-63
      product ndcs
      1. 69448-022
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. SUBCUTANEOUS
        rxcuis
        1. 2747255
        2. 2747262
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00600.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
        600
        total
        830
        sha256
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        url
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        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22caa201eb-143f-4390-9788-894e1810fee8%22
        spl effective date
        2026-07-14
        spl effective time
        20260714
        spl set id
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        spl version
        3
        substance names
        1. DENOSUMAB
        uniis
        1. 4EQZ6YO2HI
        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
          BLA761424
          payload
          all indexed label documents
          1. Appl No
            761424
            Application Docs Date
            2025-10-31 00:00:00
            Application Docs ID
            84006
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          all submission records
          1. Appl No
            761424
            Review Priority
            STANDARD
            Submission Class Code ID
            19
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2025-10-29 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          application number
          BLA761424
          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
          2025-10-29
          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
            761424
            Application Docs Date
            2025-10-31 00:00:00
            Application Docs ID
            84006
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          official application record
          Appl No
          761424
          Appl Public Notes
          Appl Type
          BLA
          Sponsor Name
          ACCORD BIOPHARMA INC.
          openfda application present
          true
          products
          1. Active Ingredient
            denosumab-desu
            Appl No
            761424
            Drug Name
            OSVYRTI
            Form
            INJECTABLE;SUBCUTANEOUS
            Product No
            001
            Reference Drug
            0
            Reference Standard
            0
            Strength
            60MG/ML
            marketing status
            1. Prescription
          2. Active Ingredient
            denosumab-desu
            Appl No
            761424
            Drug Name
            JUBEREQ
            Form
            INJECTABLE;SUBCUTANEOUS
            Product No
            002
            Reference Drug
            0
            Reference Standard
            0
            Strength
            120MG/1.7ML
            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. BLA761424
        brand names
        1. JUBEREQ
        classification reasons
        1. explicit_positive_indication_predicate
        2. supportive_or_complication_use_words
        clinical review status
        pending
        content role
        positive_indication_candidate
        context span
        end
        409
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE Jubereq is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) Tr
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        generic names
        1. DENOSUMAB-DESU
        id
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        label id
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        positive predicate support span
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        exact text
        is a RANK ligand (RANKL) inhibitor indicated
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        qualifier mentions
        1. context exact
          in patients with multiple myeloma and in patients with bone metastases from solid tumors.
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          208
          end exclusive
          true
          exact text
          metastases from solid tumors
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        regulatory links
          schema version
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          source defined aliases
            source span
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            209
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE Jubereq is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
            label id
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            offset unit
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            start
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            source url
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            spl effective date
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            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
            supportive_care_candidate
            Passage 2 · positive indication candidate
            application numbers
            1. BLA761424
            brand names
            1. JUBEREQ
            classification reasons
            1. inherited_predicate_from_same_label_section_requires_review
            2. tumor_or_malignant_hematology_words_in_positive_statement
            clinical review status
            pending
            content role
            positive_indication_candidate
            context span
            end
            591
            end exclusive
            true
            exact text
            ONS AND USAGE Jubereq is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Jubereq is indicated for the preventio
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            source array index
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            source text sha256
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            not_reconciled
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            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. DENOSUMAB-DESU
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            label id
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            positive predicate support span
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            true
            exact text
            is a RANK ligand (RANKL) inhibitor indicated
            label id
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            offset unit
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            source text sha256
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            qualifier mentions
            1. context exact
              ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of
              kind
              age
              polarity
              not_inferred
              span
              end
              237
              end exclusive
              true
              exact text
              adults
              label id
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              source array index
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            2. context exact
              ly mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
              kind
              stage_or_setting
              polarity
              not_inferred
              span
              end
              357
              end exclusive
              true
              exact text
              unresectable or where surgical resection is lik
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              offset unit
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              source array index
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              source field
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            regulatory links
              schema version
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              source batch sha256
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              source defined aliases
                source span
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                end exclusive
                true
                exact text
                ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
                label id
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                offset unit
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                source array index
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                source field
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                source text sha256
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                source url
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                spl effective date
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                spl set id
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                spl version
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                structured fields status
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                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 3 · unclassified context
                application numbers
                1. BLA761424
                brand names
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                classification reasons
                1. no_unambiguous_positive_indication_predicate
                clinical review status
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                685
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                exact text
                rom solid tumors. ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Jubereq is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metas
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                  ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
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                    ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
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                    source url
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                    spl effective date
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                    Source null
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                    Source null
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                    Source null
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                    Source null
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                    Source null
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                    Source null
                    use intent
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                    Passage 4 · unclassified context
                    application numbers
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                    l tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Jubereq is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases fr
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                    current approval status
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                          exact text
                          ( 1.3 )
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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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                          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
                          unclear
                          Passage 5 · positive indication candidate
                          application numbers
                          1. BLA761424
                          brand names
                          1. JUBEREQ
                          classification reasons
                          1. explicit_positive_indication_predicate
                          2. supportive_or_complication_use_words
                          clinical review status
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                          content role
                          positive_indication_candidate
                          context span
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                                      Preserved source evidence · Not medical advice