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LABELS · 316974bf-2b6d-9d66-e063-6294a90a33a9

Zytiga

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2025-03-28
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE ZYTIGA is indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prostate cancer (CSPC) ZYTIGA is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). ( 1 ) metastatic high-risk castration-sensitive prostate cancer (CSPC). ( 1 )
Full extracted label fields
application numbers
  1. NDA202379
boxed warning exact
    brand names
    1. Zytiga
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4e338e89-3cf2-48eb-b6e2-a06c608c6513
    generic names
    1. ABIRATERONE ACETATE
    id
    316974bf-2b6d-9d66-e063-6294a90a33a9
    indications and usage exact
    1. 1 INDICATIONS AND USAGE ZYTIGA is indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prostate cancer (CSPC) ZYTIGA is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). ( 1 ) metastatic high-risk castration-sensitive prostate cancer (CSPC). ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Janssen Biotech, Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 57894-150-12
      2. 57894-150-25
      3. 57894-195-06
      4. 57894-195-15
      product ndcs
      1. 57894-150
      2. 57894-195
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 1100075
        2. 1100079
        3. 1918042
        4. 1918044
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00100.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
        100
        total
        830
        sha256
        fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
        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=100&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22316974bf-2b6d-9d66-e063-6294a90a33a9%22
        spl effective date
        2025-03-28
        spl effective time
        20250328
        spl set id
        4e338e89-3cf2-48eb-b6e2-a06c608c6513
        spl version
        40
        substance names
        1. ABIRATERONE ACETATE
        uniis
        1. EM5OCB9YJ6
        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
          NDA202379
          payload
          all indexed label documents
          1. Appl No
            202379
            Application Docs Date
            2011-04-28 00:00:00
            Application Docs ID
            19336
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            202379
            Application Docs Date
            2012-12-14 00:00:00
            Application Docs ID
            19337
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            5
            Submission Type
            SUPPL
          3. Appl No
            202379
            Application Docs Date
            2013-09-17 00:00:00
            Application Docs ID
            19338
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            7
            Submission Type
            SUPPL
          4. Appl No
            202379
            Application Docs Date
            2014-05-15 00:00:00
            Application Docs ID
            19339
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            9
            Submission Type
            SUPPL
          5. Appl No
            202379
            Application Docs Date
            2015-03-24 00:00:00
            Application Docs ID
            19340
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            16
            Submission Type
            SUPPL
          6. Appl No
            202379
            Application Docs Date
            2015-05-27 00:00:00
            Application Docs ID
            19341
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            18
            Submission Type
            SUPPL
          7. Appl No
            202379
            Application Docs Date
            2015-12-15 00:00:00
            Application Docs ID
            19342
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            21
            Submission Type
            SUPPL
          8. Appl No
            202379
            Application Docs Date
            2012-07-13 00:00:00
            Application Docs ID
            40175
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            3
            Submission Type
            SUPPL
          9. Appl No
            202379
            Application Docs Date
            2012-09-17 00:00:00
            Application Docs ID
            40176
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            4
            Submission Type
            SUPPL
          10. Appl No
            202379
            Application Docs Date
            2015-01-29 00:00:00
            Application Docs ID
            40177
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            15
            Submission Type
            SUPPL
          11. Appl No
            202379
            Application Docs Date
            2016-05-20 00:00:00
            Application Docs ID
            40178
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            23
            Submission Type
            SUPPL
          12. Appl No
            202379
            Application Docs Date
            2018-02-12 00:00:00
            Application Docs ID
            52563
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            24
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            202379
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            35
            Submission Status
            AP
            Submission Status Date
            2021-08-23 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          2. Appl No
            202379
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            33
            Submission Status
            AP
            Submission Status Date
            2020-10-02 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            202379
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            31
            Submission Status
            AP
            Submission Status Date
            2020-10-02 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            202379
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            28
            Submission Status
            AP
            Submission Status Date
            2019-06-03 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            202379
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            27
            Submission Status
            AP
            Submission Status Date
            2019-06-03 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            202379
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            25
            Submission Status
            AP
            Submission Status Date
            2018-09-25 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            202379
            Review Priority
            PRIORITY
            Submission Class Code ID
            2
            Submission No
            24
            Submission Status
            AP
            Submission Status Date
            2018-02-07 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            202379
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            23
            Submission Status
            AP
            Submission Status Date
            2016-05-17 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            202379
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            21
            Submission Status
            AP
            Submission Status Date
            2015-12-10 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          10. Appl No
            202379
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            20
            Submission Status
            AP
            Submission Status Date
            2015-08-18 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          11. Appl No
            202379
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            18
            Submission Status
            AP
            Submission Status Date
            2015-05-20 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          12. Appl No
            202379
            Review Priority
            PRIORITY
            Submission Class Code ID
            4
            Submission No
            17
            Submission Status
            AP
            Submission Status Date
            2015-03-03 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA202379
          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
          2021-08-23
          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
            202379
            Application Docs Date
            2021-08-25 00:00:00
            Application Docs ID
            68458
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            35
            Submission Type
            SUPPL
          official application record
          Appl No
          202379
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          JANSSEN BIOTECH
          openfda application present
          true
          products
          1. Active Ingredient
            ABIRATERONE ACETATE
            Appl No
            202379
            Drug Name
            ZYTIGA
            Form
            TABLET;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            0
            Strength
            250MG
            marketing status
            1. Prescription
          2. Active Ingredient
            ABIRATERONE ACETATE
            Appl No
            202379
            Drug Name
            ZYTIGA
            Form
            TABLET;ORAL
            Product No
            002
            Reference Drug
            1
            Reference Standard
            1
            Strength
            500MG
            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. NDA202379
        brand names
        1. Zytiga
        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
        467
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE ZYTIGA is indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prostate cancer (CSPC) ZYTIGA is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). ( 1 ) metastatic high-risk castration-sensitive prostate cancer (CSPC). ( 1 )
        label id
        316974bf-2b6d-9d66-e063-6294a90a33a9
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        6f2398d8846d93870e5e65bdd1861fbaedb0b5e00922dd7e3667aab34b1b9509
        start
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        current approval status
        not_reconciled
        duplicate text group
        dup-26dad8b9b761d44a1e6e
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. ABIRATERONE ACETATE
        id
        ind-span-472d6cfaa14084dea6d3
        label id
        316974bf-2b6d-9d66-e063-6294a90a33a9
        positive predicate support span
        end
        43
        end exclusive
        true
        exact text
        is indicated
        label id
        316974bf-2b6d-9d66-e063-6294a90a33a9
        offset unit
        unicode_code_points
        source array index
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        source field
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        source text sha256
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        start
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        qualifier mentions
        1. context exact
          bination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prosta
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          153
          end exclusive
          true
          exact text
          Metastatic castration-resistant prostate ca
          label id
          316974bf-2b6d-9d66-e063-6294a90a33a9
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
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          start
          110
        2. context exact
          with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prostate cancer (CSPC) ZYTIGA is a CYP17 inhibitor indicated
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          208
          end exclusive
          true
          exact text
          Metastatic high-risk castration-sensitive p
          label id
          316974bf-2b6d-9d66-e063-6294a90a33a9
          offset unit
          unicode_code_points
          source array index
          0
          source field
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          source text sha256
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          start
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        3. context exact
          bination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          377
          end exclusive
          true
          exact text
          metastatic castration-resistant prostate ca
          label id
          316974bf-2b6d-9d66-e063-6294a90a33a9
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          6f2398d8846d93870e5e65bdd1861fbaedb0b5e00922dd7e3667aab34b1b9509
          start
          334
        4. context exact
          bination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prostate
          kind
          stage_or_setting
          polarity
          not_inferred
          span
          end
          155
          end exclusive
          true
          exact text
          Metastatic castration-resistant prostate canc
          label id
          316974bf-2b6d-9d66-e063-6294a90a33a9
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          6f2398d8846d93870e5e65bdd1861fbaedb0b5e00922dd7e3667aab34b1b9509
          start
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        5. context exact
          with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prostate cancer (CSPC) ZYTIGA is a CYP17 inhibitor indicated in
          kind
          stage_or_setting
          polarity
          not_inferred
          span
          end
          210
          end exclusive
          true
          exact text
          Metastatic high-risk castration-sensitive pro
          label id
          316974bf-2b6d-9d66-e063-6294a90a33a9
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          6f2398d8846d93870e5e65bdd1861fbaedb0b5e00922dd7e3667aab34b1b9509
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        6. context exact
          bination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).
          kind
          stage_or_setting
          polarity
          not_inferred
          span
          end
          379
          end exclusive
          true
          exact text
          metastatic castration-resistant prostate canc
          label id
          316974bf-2b6d-9d66-e063-6294a90a33a9
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          6f2398d8846d93870e5e65bdd1861fbaedb0b5e00922dd7e3667aab34b1b9509
          start
          334
        7. context exact
          1 INDICATIONS AND USAGE ZYTIGA is indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prostate cancer (CSPC) ZYTIGA is a CYP17 inhibitor indicated in combination
          kind
          regimen
          polarity
          not_inferred
          span
          end
          223
          end exclusive
          true
          exact text
          in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prostate cancer
          label id
          316974bf-2b6d-9d66-e063-6294a90a33a9
          offset unit
          unicode_code_points
          source array index
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          source field
          indications_and_usage_exact
          source text sha256
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          start
          44
        8. context exact
          rostate cancer (CSPC) ZYTIGA is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).
          kind
          regimen
          polarity
          not_inferred
          span
          end
          388
          end exclusive
          true
          exact text
          in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC)
          label id
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          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
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          start
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        regulatory links
          schema version
          0.1.0
          source batch sha256
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          source defined aliases
            source span
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            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE ZYTIGA is indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prostate cancer (CSPC) ZYTIGA is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).
            label id
            316974bf-2b6d-9d66-e063-6294a90a33a9
            offset unit
            unicode_code_points
            source array index
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            source field
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            source text sha256
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            start
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            source url
            https://api.fda.gov/drug/label.json?search=id%3A%22316974bf-2b6d-9d66-e063-6294a90a33a9%22
            spl effective date
            2025-03-28
            spl set id
            4e338e89-3cf2-48eb-b6e2-a06c608c6513
            spl version
            40
            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 2 · unclassified context
            application numbers
            1. NDA202379
            brand names
            1. Zytiga
            classification reasons
            1. no_unambiguous_positive_indication_predicate
            clinical review status
            pending
            content role
            unclassified_context
            context span
            end
            467
            end exclusive
            true
            exact text
            ration-sensitive prostate cancer (CSPC) ZYTIGA is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). ( 1 ) metastatic high-risk castration-sensitive prostate cancer (CSPC). ( 1 )
            label id
            316974bf-2b6d-9d66-e063-6294a90a33a9
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
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            start
            190
            current approval status
            not_reconciled
            duplicate text group
            dup-ef5d9c4669a0ef36d6c6
            extraction review status
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            qualifier mentions
            1. context exact
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              span
              end
              439
              end exclusive
              true
              exact text
              metastatic high-risk castration-sensitive p
              label id
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              ( 1 ) metastatic high-risk castration-sensitive prostate cancer (CSPC).
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              441
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              true
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              metastatic high-risk castration-sensitive pro
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                end exclusive
                true
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                prior therapy
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                regimen
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                tumor histology
                Source null
                use intent
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                Passage 3 · unclassified context
                application numbers
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                classification reasons
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                cated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). ( 1 ) metastatic high-risk castration-sensitive prostate cancer (CSPC). ( 1 )
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                Source null
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                      467
                      end exclusive
                      true
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                      ( 1 )
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                      spl set id
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                      structured fields status
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                      approval pathway
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                      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

                      Preserved source evidence · Not medical advice