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LABELS · 019c406f-d5d0-d9d0-25c1-664d4dc4e776

AUKELSO

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
2026-03-27
Captured
2026-09-09T23:37:39.774134+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Aukelso 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 Aukelso 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 Aukelso 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 Aukelso is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
Full extracted label fields
application numbers
  1. BLA761436
boxed warning exact
    brand names
    1. AUKELSO
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=547cb095-f7f5-f933-75ce-5e6abf2ad5bc
    generic names
    1. DENOSUMAB-KYQQ
    id
    019c406f-d5d0-d9d0-25c1-664d4dc4e776
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Aukelso 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 Aukelso 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 Aukelso 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 Aukelso 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. Biocon Biologics Inc.
      matched search terms
      1. myeloma
      2. tumor
      3. tumors
      4. malignancy
      package ndcs
      1. 83257-030-11
      product ndcs
      1. 83257-030
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      record type
      complete_spl_indications_section_candidate
      routes
      1. SUBCUTANEOUS
      rxcuis
      1. 2725939
      2. 2725946
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00000.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
      0
      total
      830
      sha256
      0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
      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=0&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%22019c406f-d5d0-d9d0-25c1-664d4dc4e776%22
      spl effective date
      2026-03-27
      spl effective time
      20260327
      spl set id
      547cb095-f7f5-f933-75ce-5e6abf2ad5bc
      spl version
      3
      substance names
      1. DENOSUMAB
      uniis
      1. 4EQZ6YO2HI
      verification flags
      1. oncology_keyword_candidate_not_clinically_classified
      2. spl_text_not_verified_identical_to_latest_approved_label
      3. individual_indications_not_split_or_reconciled
      Drugs@FDA application source records
      1. application number
        BLA761436
        payload
        all indexed label documents
        1. Appl No
          761436
          Application Docs Date
          2025-09-17 00:00:00
          Application Docs ID
          83371
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          761436
          Application Docs Date
          2025-10-31 00:00:00
          Application Docs ID
          84020
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          ORIG
        all submission records
        1. Appl No
          761436
          Review Priority
          STANDARD
          Submission Class Code ID
          19
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2025-09-16 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          761436
          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
        BLA761436
        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
          761436
          Application Docs Date
          2025-10-31 00:00:00
          Application Docs ID
          84020
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          ORIG
        official application record
        Appl No
        761436
        Appl Public Notes
        Appl Type
        BLA
        Sponsor Name
        BIOCON BIOLOGICS INC
        openfda application present
        true
        products
        1. Active Ingredient
          DENOSUMAB-KYQQ
          Appl No
          761436
          Drug Name
          AUKELSO
          Form
          INJECTABLE;INJECTION
          Product No
          001
          Reference Drug
          0
          Reference Standard
          0
          Strength
          120MG/1.7ML(70MG/ML)
          marketing status
          1. Prescription
        2. Active Ingredient
          DENOSUMAB-KYQQ
          Appl No
          761436
          Drug Name
          BOSAYA
          Form
          INJECTABLE;INJECTION
          Product No
          002
          Reference Drug
          0
          Reference Standard
          0
          Strength
          60MG/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. BLA761436
      brand names
      1. AUKELSO
      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 Aukelso 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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      duplicate text group
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      generic names
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      id
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      label id
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      positive predicate support span
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      true
      exact text
      is a RANK ligand (RANKL) inhibitor indicated
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      unicode_code_points
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      source field
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      source text sha256
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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
        label id
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      regulatory links
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          true
          exact text
          1 INDICATIONS AND USAGE Aukelso 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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          source field
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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. BLA761436
          brand names
          1. AUKELSO
          classification reasons
          1. inherited_predicate_from_same_label_section_requires_review
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          clinical review status
          pending
          content role
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          context span
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          591
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          true
          exact text
          ONS AND USAGE Aukelso 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 Aukelso is indicated for the preventio
          label id
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          extraction review status
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          generic names
          1. DENOSUMAB-KYQQ
          id
          ind-span-34d14e726c14f2d7a672
          label id
          019c406f-d5d0-d9d0-25c1-664d4dc4e776
          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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          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
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            end exclusive
            true
            exact text
            unresectable or where surgical resection is lik
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          regulatory links
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              391
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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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              spl version
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              structured fields status
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              Source null
              approval pathway
              Source null
              biomarker and test
              Source null
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              Source null
              limitations
              Source null
              line
              Source null
              prior therapy
              Source null
              regimen
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              Source null
              use intent
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              Passage 3 · unclassified context
              application numbers
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              brand names
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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 Aukelso is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metas
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                  source url
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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 Aukelso 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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                        ( 1.3 )
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                        source url
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                        spl effective date
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                        structured fields status
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                                    Preserved source evidence · Not medical advice