Skip to content
Triangle logo TriangleGet started
← Back to this collection

LABELS · ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b

Osenvelt

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
2026-02-05
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 Osenvelt 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 Osenvelt 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 Osenvelt 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 Osenvelt is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
Full extracted label fields
application numbers
  1. BLA761404
boxed warning exact
    brand names
    1. Osenvelt
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c5a5d750-80be-49cd-b4a6-c8a815956059
    generic names
    1. DENOSUMAB-BMWO
    id
    ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Osenvelt 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 Osenvelt 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 Osenvelt 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 Osenvelt 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. CELLTRION USA, Inc.
      matched search terms
      1. myeloma
      2. tumor
      3. tumors
      4. malignancy
      package ndcs
      1. 72606-038-01
      product ndcs
      1. 72606-038
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. SUBCUTANEOUS
        rxcuis
        1. 2717866
        2. 2717873
        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
        a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
        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=600&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b%22
        spl effective date
        2026-02-05
        spl effective time
        20260205
        spl set id
        c5a5d750-80be-49cd-b4a6-c8a815956059
        spl version
        7
        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
          BLA761404
          payload
          all indexed label documents
          1. Appl No
            761404
            Application Docs Date
            2025-02-28 00:00:00
            Application Docs ID
            81384
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            761404
            Application Docs Date
            2025-03-10 00:00:00
            Application Docs ID
            81505
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          3. Appl No
            761404
            Application Docs Date
            2025-09-17 00:00:00
            Application Docs ID
            83361
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            3
            Submission Type
            SUPPL
          4. Appl No
            761404
            Application Docs Date
            2025-10-31 00:00:00
            Application Docs ID
            84010
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            2
            Submission Type
            ORIG
          all submission records
          1. Appl No
            761404
            Review Priority
            STANDARD
            Submission Class Code ID
            19
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2025-02-28 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            761404
            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
          3. Appl No
            761404
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            3
            Submission Status
            AP
            Submission Status Date
            2025-09-10 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          BLA761404
          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
            761404
            Application Docs Date
            2025-10-31 00:00:00
            Application Docs ID
            84010
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            2
            Submission Type
            ORIG
          official application record
          Appl No
          761404
          Appl Public Notes
          Appl Type
          BLA
          Sponsor Name
          CELLTRION INC
          openfda application present
          true
          products
          1. Active Ingredient
            DENOSUMAB-BMWO
            Appl No
            761404
            Drug Name
            STOBOCLO
            Form
            INJECTABLE;INJECTION
            Product No
            001
            Reference Drug
            0
            Reference Standard
            0
            Strength
            60MG/ML
            marketing status
            1. Prescription
          2. Active Ingredient
            DENOSUMAB-BMWO
            Appl No
            761404
            Drug Name
            OSENVELT
            Form
            INJECTABLE;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. BLA761404
        brand names
        1. Osenvelt
        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
        410
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE Osenvelt 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
        label id
        ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        6a1d86ec6323ea50e95e914a5ae0e42159686b50d7d499faeaef6849726fb90a
        start
        0
        current approval status
        not_reconciled
        duplicate text group
        dup-3f84370b81e70e3c3798
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. DENOSUMAB-BMWO
        id
        ind-span-89ed976bb0d11930e6e7
        label id
        ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
        positive predicate support span
        end
        77
        end exclusive
        true
        exact text
        is a RANK ligand (RANKL) inhibitor indicated
        label id
        ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        6a1d86ec6323ea50e95e914a5ae0e42159686b50d7d499faeaef6849726fb90a
        start
        33
        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
          209
          end exclusive
          true
          exact text
          metastases from solid tumors
          label id
          ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          6a1d86ec6323ea50e95e914a5ae0e42159686b50d7d499faeaef6849726fb90a
          start
          181
        regulatory links
          schema version
          0.1.0
          source batch sha256
          a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
          source defined aliases
            source span
            end
            210
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE Osenvelt 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
            ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            6a1d86ec6323ea50e95e914a5ae0e42159686b50d7d499faeaef6849726fb90a
            start
            0
            source url
            https://api.fda.gov/drug/label.json?search=id%3A%22ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b%22
            spl effective date
            2026-02-05
            spl set id
            c5a5d750-80be-49cd-b4a6-c8a815956059
            spl version
            7
            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. BLA761404
            brand names
            1. Osenvelt
            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
            592
            end exclusive
            true
            exact text
            NS AND USAGE Osenvelt 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 Osenvelt is indicated for the preventi
            label id
            ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            6a1d86ec6323ea50e95e914a5ae0e42159686b50d7d499faeaef6849726fb90a
            start
            11
            current approval status
            not_reconciled
            duplicate text group
            dup-9859a4ecced4d55d7bdf
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. DENOSUMAB-BMWO
            id
            ind-span-b4c27219e75c7aa2ce5e
            label id
            ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
            positive predicate support span
            end
            77
            end exclusive
            true
            exact text
            is a RANK ligand (RANKL) inhibitor indicated
            label id
            ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            6a1d86ec6323ea50e95e914a5ae0e42159686b50d7d499faeaef6849726fb90a
            start
            33
            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
              238
              end exclusive
              true
              exact text
              adults
              label id
              ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              6a1d86ec6323ea50e95e914a5ae0e42159686b50d7d499faeaef6849726fb90a
              start
              232
            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
              358
              end exclusive
              true
              exact text
              unresectable or where surgical resection is lik
              label id
              ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              6a1d86ec6323ea50e95e914a5ae0e42159686b50d7d499faeaef6849726fb90a
              start
              311
            regulatory links
              schema version
              0.1.0
              source batch sha256
              a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
              source defined aliases
                source span
                end
                392
                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
                ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                6a1d86ec6323ea50e95e914a5ae0e42159686b50d7d499faeaef6849726fb90a
                start
                211
                source url
                https://api.fda.gov/drug/label.json?search=id%3A%22ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b%22
                spl effective date
                2026-02-05
                spl set id
                c5a5d750-80be-49cd-b4a6-c8a815956059
                spl version
                7
                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 3 · unclassified context
                application numbers
                1. BLA761404
                brand names
                1. Osenvelt
                classification reasons
                1. no_unambiguous_positive_indication_predicate
                clinical review status
                pending
                content role
                unclassified_context
                context span
                end
                686
                end exclusive
                true
                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 Osenvelt is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone meta
                label id
                ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                6a1d86ec6323ea50e95e914a5ae0e42159686b50d7d499faeaef6849726fb90a
                start
                193
                current approval status
                not_reconciled
                duplicate text group
                dup-b9985b68b1c2cd0d810c
                extraction review status
                automated_candidate_pending_source_review
                generic names
                1. DENOSUMAB-BMWO
                id
                ind-span-657e818a6d9c4aedc010
                label id
                ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
                positive predicate support span
                Source null
                qualifier mentions
                1. context exact
                  ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
                  kind
                  stage_or_setting
                  polarity
                  not_inferred
                  span
                  end
                  485
                  end exclusive
                  true
                  exact text
                  refractory to bisphosphonate therapy
                  label id
                  ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  6a1d86ec6323ea50e95e914a5ae0e42159686b50d7d499faeaef6849726fb90a
                  start
                  449
                regulatory links
                  schema version
                  0.1.0
                  source batch sha256
                  a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                  source defined aliases
                    source span
                    end
                    486
                    end exclusive
                    true
                    exact text
                    ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
                    label id
                    ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    6a1d86ec6323ea50e95e914a5ae0e42159686b50d7d499faeaef6849726fb90a
                    start
                    393
                    source url
                    https://api.fda.gov/drug/label.json?search=id%3A%22ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b%22
                    spl effective date
                    2026-02-05
                    spl set id
                    c5a5d750-80be-49cd-b4a6-c8a815956059
                    spl version
                    7
                    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
                    unclear
                    Passage 4 · unclassified context
                    application numbers
                    1. BLA761404
                    brand names
                    1. Osenvelt
                    classification reasons
                    1. no_unambiguous_positive_indication_predicate
                    clinical review status
                    pending
                    content role
                    unclassified_context
                    context span
                    end
                    694
                    end exclusive
                    true
                    exact text
                    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 Osenvelt is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases f
                    label id
                    ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    6a1d86ec6323ea50e95e914a5ae0e42159686b50d7d499faeaef6849726fb90a
                    start
                    287
                    current approval status
                    not_reconciled
                    duplicate text group
                    dup-ceb2fb07f57259119e17
                    extraction review status
                    automated_candidate_pending_source_review
                    generic names
                    1. DENOSUMAB-BMWO
                    id
                    ind-span-5be2e471692f646f80de
                    label id
                    ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
                    positive predicate support span
                    Source null
                    qualifier mentions
                      regulatory links
                        schema version
                        0.1.0
                        source batch sha256
                        a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                        source defined aliases
                          source span
                          end
                          494
                          end exclusive
                          true
                          exact text
                          ( 1.3 )
                          label id
                          ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
                          offset unit
                          unicode_code_points
                          source array index
                          0
                          source field
                          indications_and_usage_exact
                          source text sha256
                          6a1d86ec6323ea50e95e914a5ae0e42159686b50d7d499faeaef6849726fb90a
                          start
                          487
                          source url
                          https://api.fda.gov/drug/label.json?search=id%3A%22ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b%22
                          spl effective date
                          2026-02-05
                          spl set id
                          c5a5d750-80be-49cd-b4a6-c8a815956059
                          spl version
                          7
                          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
                          unclear
                          Passage 5 · positive indication candidate
                          application numbers
                          1. BLA761404
                          brand names
                          1. Osenvelt
                          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
                          911
                          end exclusive
                          true
                          exact text
                          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 Osenvelt 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 Osenvelt 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 like
                          label id
                          ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
                          offset unit
                          unicode_code_points
                          source array index
                          0
                          source field
                          indications_and_usage_exact
                          source text sha256
                          6a1d86ec6323ea50e95e914a5ae0e42159686b50d7d499faeaef6849726fb90a
                          start
                          295
                          current approval status
                          not_reconciled
                          duplicate text group
                          dup-3452c63aa1836965f784
                          extraction review status
                          automated_candidate_pending_source_review
                          generic names
                          1. DENOSUMAB-BMWO
                          id
                          ind-span-d585c7afbfbf7963fc6b
                          label id
                          ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
                          positive predicate support span
                          end
                          575
                          end exclusive
                          true
                          exact text
                          is indicated
                          label id
                          ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
                          offset unit
                          unicode_code_points
                          source array index
                          0
                          source field
                          indications_and_usage_exact
                          source text sha256
                          6a1d86ec6323ea50e95e914a5ae0e42159686b50d7d499faeaef6849726fb90a
                          start
                          563
                          qualifier mentions
                          1. context exact
                            1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Osenvelt is indicated for the prevention of skeletal-related events in pat
                            kind
                            biomarker
                            polarity
                            not_inferred
                            span
                            end
                            568
                            end exclusive
                            true
                            exact text
                            Metastasis from Solid Tumors Osenvelt is in
                            label id
                            ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            6a1d86ec6323ea50e95e914a5ae0e42159686b50d7d499faeaef6849726fb90a
                            start
                            525
                          2. context exact
                            in patients with multiple myeloma and in patients with bone metastases from solid tumors.
                            kind
                            biomarker
                            polarity
                            not_inferred
                            span
                            end
                            710
                            end exclusive
                            true
                            exact text
                            metastases from solid tumors
                            label id
                            ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            6a1d86ec6323ea50e95e914a5ae0e42159686b50d7d499faeaef6849726fb90a
                            start
                            682
                          regulatory links
                            schema version
                            0.1.0
                            source batch sha256
                            a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                            source defined aliases
                              source span
                              end
                              711
                              end exclusive
                              true
                              exact text
                              1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Osenvelt is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
                              label id
                              ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              6a1d86ec6323ea50e95e914a5ae0e42159686b50d7d499faeaef6849726fb90a
                              start
                              495
                              source url
                              https://api.fda.gov/drug/label.json?search=id%3A%22ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b%22
                              spl effective date
                              2026-02-05
                              spl set id
                              c5a5d750-80be-49cd-b4a6-c8a815956059
                              spl version
                              7
                              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 6 · positive indication candidate
                              application numbers
                              1. BLA761404
                              brand names
                              1. Osenvelt
                              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
                              1116
                              end exclusive
                              true
                              exact text
                              oma and Bone Metastasis from Solid Tumors Osenvelt 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 Osenvelt 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 Osenvelt is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
                              label id
                              ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              6a1d86ec6323ea50e95e914a5ae0e42159686b50d7d499faeaef6849726fb90a
                              start
                              512
                              current approval status
                              not_reconciled
                              duplicate text group
                              dup-ffea4e9d0a763dd419f2
                              extraction review status
                              automated_candidate_pending_source_review
                              generic names
                              1. DENOSUMAB-BMWO
                              id
                              ind-span-9faa2ef3568a51c64807
                              label id
                              ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
                              positive predicate support span
                              end
                              762
                              end exclusive
                              true
                              exact text
                              is indicated
                              label id
                              ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              6a1d86ec6323ea50e95e914a5ae0e42159686b50d7d499faeaef6849726fb90a
                              start
                              750
                              qualifier mentions
                              1. context exact
                                ll Tumor of Bone Osenvelt is indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of
                                kind
                                age
                                polarity
                                not_inferred
                                span
                                end
                                790
                                end exclusive
                                true
                                exact text
                                adults
                                label id
                                ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                6a1d86ec6323ea50e95e914a5ae0e42159686b50d7d499faeaef6849726fb90a
                                start
                                784
                              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 [see Clinical Trials (14.2
                                kind
                                stage_or_setting
                                polarity
                                not_inferred
                                span
                                end
                                910
                                end exclusive
                                true
                                exact text
                                unresectable or where surgical resection is lik
                                label id
                                ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                6a1d86ec6323ea50e95e914a5ae0e42159686b50d7d499faeaef6849726fb90a
                                start
                                863
                              regulatory links
                                schema version
                                0.1.0
                                source batch sha256
                                a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                                source defined aliases
                                  source span
                                  end
                                  975
                                  end exclusive
                                  true
                                  exact text
                                  1.2 Giant Cell Tumor of Bone Osenvelt 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) ] .
                                  label id
                                  ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  6a1d86ec6323ea50e95e914a5ae0e42159686b50d7d499faeaef6849726fb90a
                                  start
                                  712
                                  source url
                                  https://api.fda.gov/drug/label.json?search=id%3A%22ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b%22
                                  spl effective date
                                  2026-02-05
                                  spl set id
                                  c5a5d750-80be-49cd-b4a6-c8a815956059
                                  spl version
                                  7
                                  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 7 · positive indication candidate
                                  application numbers
                                  1. BLA761404
                                  brand names
                                  1. Osenvelt
                                  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
                                  1116
                                  end exclusive
                                  true
                                  exact text
                                  ment 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 Osenvelt is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
                                  label id
                                  ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  6a1d86ec6323ea50e95e914a5ae0e42159686b50d7d499faeaef6849726fb90a
                                  start
                                  776
                                  current approval status
                                  not_reconciled
                                  duplicate text group
                                  dup-ab9eb1a80ef7462f71ca
                                  extraction review status
                                  automated_candidate_pending_source_review
                                  generic names
                                  1. DENOSUMAB-BMWO
                                  id
                                  ind-span-f8bd6d52bec3bd422017
                                  label id
                                  ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
                                  positive predicate support span
                                  end
                                  1029
                                  end exclusive
                                  true
                                  exact text
                                  is indicated
                                  label id
                                  ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  6a1d86ec6323ea50e95e914a5ae0e42159686b50d7d499faeaef6849726fb90a
                                  start
                                  1017
                                  qualifier mentions
                                  1. context exact
                                    indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
                                    kind
                                    stage_or_setting
                                    polarity
                                    not_inferred
                                    span
                                    end
                                    1115
                                    end exclusive
                                    true
                                    exact text
                                    refractory to bisphosphonate therapy
                                    label id
                                    ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
                                    offset unit
                                    unicode_code_points
                                    source array index
                                    0
                                    source field
                                    indications_and_usage_exact
                                    source text sha256
                                    6a1d86ec6323ea50e95e914a5ae0e42159686b50d7d499faeaef6849726fb90a
                                    start
                                    1079
                                  regulatory links
                                    schema version
                                    0.1.0
                                    source batch sha256
                                    a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                                    source defined aliases
                                      source span
                                      end
                                      1116
                                      end exclusive
                                      true
                                      exact text
                                      1.3 Hypercalcemia of Malignancy Osenvelt is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
                                      label id
                                      ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
                                      offset unit
                                      unicode_code_points
                                      source array index
                                      0
                                      source field
                                      indications_and_usage_exact
                                      source text sha256
                                      6a1d86ec6323ea50e95e914a5ae0e42159686b50d7d499faeaef6849726fb90a
                                      start
                                      976
                                      source url
                                      https://api.fda.gov/drug/label.json?search=id%3A%22ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b%22
                                      spl effective date
                                      2026-02-05
                                      spl set id
                                      c5a5d750-80be-49cd-b4a6-c8a815956059
                                      spl version
                                      7
                                      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

                                      Preserved source evidence · Not medical advice