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LABELS · 70159c7c-a439-4a9c-82d4-8c6da6c345eb

XTRENBO

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
2025-09-02
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Xtrenbo 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 Xtrenbo 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 Xtrenbo 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 Xtrenbo is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
Full extracted label fields
application numbers
  1. BLA761439
boxed warning exact
    brand names
    1. XTRENBO
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a48a3a33-6b0e-4cf4-8786-8f662d6ee77b
    generic names
    1. DENOSUMAB-QBDE
    id
    70159c7c-a439-4a9c-82d4-8c6da6c345eb
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Xtrenbo 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 Xtrenbo 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 Xtrenbo 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 Xtrenbo 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. Hikma Pharmaceuticals USA Inc.
      matched search terms
      1. myeloma
      2. tumor
      3. tumors
      4. malignancy
      package ndcs
      1. 0143-9166-01
      product ndcs
      1. 0143-9166
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. SUBCUTANEOUS
        rxcuis
        1. 2725590
        2. 2725597
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00400.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
        400
        total
        830
        sha256
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        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=400&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%2270159c7c-a439-4a9c-82d4-8c6da6c345eb%22
        spl effective date
        2025-09-02
        spl effective time
        20250902
        spl set id
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        spl version
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        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
        4. fda_label_posted_after_spl_effective_date_requires_version_review
        Drugs@FDA application source records
        1. application number
          BLA761439
          payload
          all indexed label documents
          1. Appl No
            761439
            Application Docs Date
            2025-09-26 00:00:00
            Application Docs ID
            83570
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            761439
            Application Docs Date
            2025-10-31 00:00:00
            Application Docs ID
            84024
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            2
            Submission Type
            ORIG
          all submission records
          1. Appl No
            761439
            Review Priority
            STANDARD
            Submission Class Code ID
            19
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2025-09-26 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            761439
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            2
            Submission Status
            AP
            Submission Status Date
            2025-10-29 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          application number
          BLA761439
          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
            761439
            Application Docs Date
            2025-10-31 00:00:00
            Application Docs ID
            84024
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            2
            Submission Type
            ORIG
          official application record
          Appl No
          761439
          Appl Public Notes
          Appl Type
          BLA
          Sponsor Name
          HIKMA PHARMACEUTICALS USA INC
          openfda application present
          true
          products
          1. Active Ingredient
            DENOSUMAB-QBDE
            Appl No
            761439
            Drug Name
            ENOBY
            Form
            SOLUTION;INJECTION
            Product No
            001
            Reference Drug
            0
            Reference Standard
            0
            Strength
            60MG/ML
            marketing status
            1. Prescription
          2. Active Ingredient
            DENOSUMAB-QBDE
            Appl No
            761439
            Drug Name
            XTRENBO
            Form
            SOLUTION;INJECTION
            Product No
            002
            Reference Drug
            0
            Reference Standard
            0
            Strength
            120MG/1.7ML(70MG/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. BLA761439
        brand names
        1. XTRENBO
        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 Xtrenbo 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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        1. DENOSUMAB-QBDE
        id
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        true
        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
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          source defined aliases
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            true
            exact text
            1 INDICATIONS AND USAGE Xtrenbo 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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            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. BLA761439
            brand names
            1. XTRENBO
            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
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            591
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            true
            exact text
            ONS AND USAGE Xtrenbo 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 Xtrenbo is indicated for the preventio
            label id
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            current approval status
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            extraction review status
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            generic names
            1. DENOSUMAB-QBDE
            id
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            label id
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            positive predicate support span
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            end exclusive
            true
            exact text
            is a RANK ligand (RANKL) inhibitor indicated
            label id
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            offset unit
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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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            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
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              end
              357
              end exclusive
              true
              exact text
              unresectable or where surgical resection is lik
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            regulatory links
              schema version
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              source defined aliases
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                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.
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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 indication
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                Source null
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                Source null
                biomarker and test
                Source null
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                Source null
                limitations
                Source null
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                Source null
                prior therapy
                Source null
                regimen
                Source null
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                Source null
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                tumor_directed_candidate
                Passage 3 · unclassified context
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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 Xtrenbo 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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                    Passage 4 · unclassified context
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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 Xtrenbo 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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                          exact text
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                          source url
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                          spl effective date
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                                      Preserved source evidence · Not medical advice