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LABELS · 3ce47aaf-105d-4615-9320-1f378a9d8d84

XGEVA

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
2026-06-23
Captured
2026-09-09T23:37:44.904352+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Xgeva 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 Xgeva 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 Xgeva 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 Xgeva is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
Full extracted label fields
application numbers
  1. BLA125320
boxed warning exact
    brand names
    1. XGEVA
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=628f0998-1206-4001-aeee-18133aa9f3bf
    generic names
    1. DENOSUMAB
    id
    3ce47aaf-105d-4615-9320-1f378a9d8d84
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Xgeva 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 Xgeva 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 Xgeva 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 Xgeva 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. Amgen, Inc
      matched search terms
      1. myeloma
      2. tumor
      3. tumors
      4. malignancy
      package ndcs
      1. 55513-730-01
      2. 55513-730-21
      product ndcs
      1. 55513-730
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Dosage and Administration ( 2.1 ) 05/2025
      record type
      complete_spl_indications_section_candidate
      routes
      1. SUBCUTANEOUS
      rxcuis
      1. 1046398
      2. 1046402
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00200.json
      meta
      disclaimer
      Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
      last updated
      2026-09-09
      results
      limit
      100
      skip
      200
      total
      830
      sha256
      d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
      url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=200&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%223ce47aaf-105d-4615-9320-1f378a9d8d84%22
      spl effective date
      2026-06-23
      spl effective time
      20260623
      spl set id
      628f0998-1206-4001-aeee-18133aa9f3bf
      spl version
      177
      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
        BLA125320
        payload
        all indexed label documents
        1. Appl No
          125320
          Application Docs Date
          2010-06-02 00:00:00
          Application Docs ID
          18862
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          125320
          Application Docs Date
          2011-09-20 00:00:00
          Application Docs ID
          18863
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        3. Appl No
          125320
          Application Docs Date
          2010-11-19 00:00:00
          Application Docs ID
          18864
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          7
          Submission Type
          SUPPL
        4. Appl No
          125320
          Application Docs Date
          2012-09-25 00:00:00
          Application Docs ID
          18865
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          51
          Submission Type
          SUPPL
        5. Appl No
          125320
          Application Docs Date
          2012-05-01 00:00:00
          Application Docs ID
          18866
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          54
          Submission Type
          SUPPL
        6. Appl No
          125320
          Application Docs Date
          2013-02-20 00:00:00
          Application Docs ID
          18867
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          80
          Submission Type
          SUPPL
        7. Appl No
          125320
          Application Docs Date
          2012-09-18 00:00:00
          Application Docs ID
          18868
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          85
          Submission Type
          SUPPL
        8. Appl No
          125320
          Application Docs Date
          2014-06-04 00:00:00
          Application Docs ID
          18869
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          155
          Submission Type
          SUPPL
        9. Appl No
          125320
          Application Docs Date
          2015-06-10 00:00:00
          Application Docs ID
          18870
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          168
          Submission Type
          SUPPL
        10. Appl No
          125320
          Application Docs Date
          2016-03-04 00:00:00
          Application Docs ID
          18871
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          177
          Submission Type
          SUPPL
        11. Appl No
          125320
          Application Docs Date
          2011-09-20 00:00:00
          Application Docs ID
          39919
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
          SUPPL
        12. Appl No
          125320
          Application Docs Date
          2012-05-16 00:00:00
          Application Docs ID
          39920
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          53
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          125320
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          225
          Submission Status
          AP
          Submission Status Date
          2026-06-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          125320
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          224
          Submission Status
          AP
          Submission Status Date
          2026-06-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          125320
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          222
          Submission Status
          AP
          Submission Status Date
          2025-05-30 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          125320
          Review Priority
          N/A
          Submission Class Code ID
          4
          Submission No
          221
          Submission Status
          AP
          Submission Status Date
          2025-04-28 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          125320
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          219
          Submission Status
          AP
          Submission Status Date
          2025-05-22 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          125320
          Review Priority
          N/A
          Submission Class Code ID
          21
          Submission No
          218
          Submission Status
          AP
          Submission Status Date
          2024-04-09 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          125320
          Review Priority
          N/A
          Submission Class Code ID
          21
          Submission No
          217
          Submission Status
          AP
          Submission Status Date
          2024-03-05 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          125320
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          216
          Submission Status
          AP
          Submission Status Date
          2024-01-19 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          125320
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          213
          Submission Status
          AP
          Submission Status Date
          2024-03-05 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          125320
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          211
          Submission Status
          AP
          Submission Status Date
          2023-01-03 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          125320
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          210
          Submission Status
          AP
          Submission Status Date
          2022-05-19 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          125320
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          207
          Submission Status
          AP
          Submission Status Date
          2021-05-12 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        BLA125320
        approval interpretation
        Application linkage and approved submission are not indication-level current approval verification
        current indication status
        not_reconciled
        has approved submission record
        true
        latest approved submission date
        2026-06-23
        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
          125320
          Application Docs Date
          2026-06-29 00:00:00
          Application Docs ID
          86373
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          224
          Submission Type
          SUPPL
        2. Appl No
          125320
          Application Docs Date
          2026-06-29 00:00:00
          Application Docs ID
          86374
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          225
          Submission Type
          SUPPL
        official application record
        Appl No
        125320
        Appl Public Notes
        Appl Type
        BLA
        Sponsor Name
        AMGEN
        openfda application present
        true
        products
        1. Active Ingredient
          DENOSUMAB
          Appl No
          125320
          Drug Name
          PROLIA
          Form
          INJECTABLE; SUBCUTANEOUS
          Product No
          001
          Reference Drug
          0
          Reference Standard
          Strength
          60MG/ML
          marketing status
          1. Prescription
        2. Active Ingredient
          DENOSUMAB
          Appl No
          125320
          Drug Name
          XGEVA
          Form
          INJECTABLE; SUBCUTANEOUS
          Product No
          002
          Reference Drug
          0
          Reference Standard
          Strength
          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. BLA125320
      brand names
      1. XGEVA
      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
      407
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE Xgeva 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
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      label id
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      true
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      is a RANK ligand (RANKL) inhibitor indicated
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      offset unit
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      start
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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
        206
        end exclusive
        true
        exact text
        metastases from solid tumors
        label id
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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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          true
          exact text
          1 INDICATIONS AND USAGE Xgeva 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.
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          source url
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          spl effective date
          2026-06-23
          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
          supportive_care_candidate
          Passage 2 · positive indication candidate
          application numbers
          1. BLA125320
          brand names
          1. XGEVA
          classification reasons
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          clinical review status
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          true
          exact text
          TIONS AND USAGE Xgeva 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 Xgeva is indicated for the prevention
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            ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of
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          2. context exact
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            unresectable or where surgical resection is lik
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              ( 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 fields status
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              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
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              brand names
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              clinical review status
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