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LABELS · 1cc0ed2a-2c33-4027-90bb-572d717b81d2

Xtandi

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
2026-07-28
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 XTANDI ® is indicated for the treatment of patients with: • castration-resistant prostate cancer (CRPC) • metastatic castration-sensitive prostate cancer (mCSPC) • non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR) XTANDI is an androgen receptor inhibitor indicated for the treatment of patients with: • castration-resistant prostate cancer. ( 1 ) • metastatic castration-sensitive prostate cancer. ( 1 ) • non‑metastatic castration‑sensitive prostate cancer with biochemical recurrence at high risk for metastasis. ( 1 )
Full extracted label fields
application numbers
  1. NDA203415
  2. NDA213674
boxed warning exact
    brand names
    1. Xtandi
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf
    generic names
    1. ENZALUTAMIDE
    id
    1cc0ed2a-2c33-4027-90bb-572d717b81d2
    indications and usage exact
    1. 1 INDICATIONS AND USAGE XTANDI ® is indicated for the treatment of patients with: • castration-resistant prostate cancer (CRPC) • metastatic castration-sensitive prostate cancer (mCSPC) • non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR) XTANDI is an androgen receptor inhibitor indicated for the treatment of patients with: • castration-resistant prostate cancer. ( 1 ) • metastatic castration-sensitive prostate cancer. ( 1 ) • non‑metastatic castration‑sensitive prostate cancer with biochemical recurrence at high risk for metastasis. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Astellas Pharma US, Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 0469-0125-99
      2. 0469-0625-99
      3. 0469-0725-60
      4. 0469-1125-56
      5. 0469-1725-56
      product ndcs
      1. 0469-0125
      2. 0469-0625
      3. 0469-0725
      4. 0469-1125
      5. 0469-1725
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions ( 5.8 ) 12/2025
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 1307303
      2. 1307309
      3. 2390644
      4. 2390646
      5. 2390648
      6. 2390650
      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%221cc0ed2a-2c33-4027-90bb-572d717b81d2%22
      spl effective date
      2026-07-28
      spl effective time
      20260728
      spl set id
      b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf
      spl version
      24
      substance names
      1. ENZALUTAMIDE
      uniis
      1. 93T0T9GKNU
      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
        NDA203415
        payload
        all indexed label documents
        1. Appl No
          203415
          Application Docs Date
          2012-08-31 00:00:00
          Application Docs ID
          19465
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          203415
          Application Docs Date
          2013-03-26 00:00:00
          Application Docs ID
          19466
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        3. Appl No
          203415
          Application Docs Date
          2015-09-21 00:00:00
          Application Docs ID
          19467
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        4. Appl No
          203415
          Application Docs Date
          2015-10-08 00:00:00
          Application Docs ID
          19468
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          7
          Submission Type
          SUPPL
        5. Appl No
          203415
          Application Docs Date
          2014-09-10 00:00:00
          Application Docs ID
          40296
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        6. Appl No
          203415
          Application Docs Date
          2015-07-22 00:00:00
          Application Docs ID
          40297
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
          SUPPL
        7. Appl No
          203415
          Application Docs Date
          2016-10-20 00:00:00
          Application Docs ID
          45577
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          9
          Submission Type
          SUPPL
        8. Appl No
          203415
          Application Docs Date
          2017-07-25 00:00:00
          Application Docs ID
          49082
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          11
          Submission Type
          SUPPL
        9. Appl No
          203415
          Application Docs Date
          2018-07-13 00:00:00
          Application Docs ID
          54886
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          14
          Submission Type
          SUPPL
        10. Appl No
          203415
          Application Docs Date
          2019-12-16 00:00:00
          Application Docs ID
          61285
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          15
          Submission Type
          SUPPL
        11. Appl No
          203415
          Application Docs Date
          2020-10-27 00:00:00
          Application Docs ID
          65042
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          16
          Submission Type
          SUPPL
        12. Appl No
          203415
          Application Docs Date
          2022-01-19 00:00:00
          Application Docs ID
          69923
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          18
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          203415
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          26
          Submission Status
          AP
          Submission Status Date
          2026-07-24 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          203415
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          25
          Submission Status
          AP
          Submission Status Date
          2025-12-11 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          203415
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          24
          Submission Status
          AP
          Submission Status Date
          2025-03-21 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          203415
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          23
          Submission Status
          AP
          Submission Status Date
          2025-01-22 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          203415
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          22
          Submission Status
          AP
          Submission Status Date
          2023-11-16 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          203415
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          19
          Submission Status
          AP
          Submission Status Date
          2022-09-09 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          203415
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          18
          Submission Status
          AP
          Submission Status Date
          2022-01-13 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          203415
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          16
          Submission Status
          AP
          Submission Status Date
          2020-10-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          203415
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          15
          Submission Status
          AP
          Submission Status Date
          2019-12-16 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          203415
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          14
          Submission Status
          AP
          Submission Status Date
          2018-07-13 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          203415
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          11
          Submission Status
          AP
          Submission Status Date
          2017-07-24 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          203415
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          10
          Submission Status
          AP
          Submission Status Date
          2016-07-14 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA203415
        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
        2026-07-24
        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
          203415
          Application Docs Date
          2026-07-27 00:00:00
          Application Docs ID
          86706
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          26
          Submission Type
          SUPPL
        official application record
        Appl No
        203415
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        ASTELLAS
        openfda application present
        true
        products
        1. Active Ingredient
          ENZALUTAMIDE
          Appl No
          203415
          Drug Name
          XTANDI
          Form
          CAPSULE;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          40MG
          marketing status
          1. Prescription
      2. application number
        NDA213674
        payload
        all indexed label documents
        1. Appl No
          213674
          Application Docs Date
          2020-08-05 00:00:00
          Application Docs ID
          64201
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          213674
          Application Docs Date
          2021-05-25 00:00:00
          Application Docs ID
          67587
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        3. Appl No
          213674
          Application Docs Date
          2022-01-19 00:00:00
          Application Docs ID
          69924
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
          SUPPL
        4. Appl No
          213674
          Application Docs Date
          2022-09-13 00:00:00
          Application Docs ID
          72073
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        5. Appl No
          213674
          Application Docs Date
          2023-11-17 00:00:00
          Application Docs ID
          76592
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          10
          Submission Type
          SUPPL
        6. Appl No
          213674
          Application Docs Date
          2025-02-12 00:00:00
          Application Docs ID
          80924
          Application Docs Title
          0
          Application Docs Type ID
          2
          Application Docs URL
          https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/203415Orig1s023; 213674Orig1s011lbl.pdf
          Submission No
          11
          Submission Type
          SUPPL
        7. Appl No
          213674
          Application Docs Date
          2025-03-24 00:00:00
          Application Docs ID
          81706
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          12
          Submission Type
          SUPPL
        8. Appl No
          213674
          Application Docs Date
          2025-12-18 00:00:00
          Application Docs ID
          84454
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          15
          Submission Type
          SUPPL
        9. Appl No
          213674
          Application Docs Date
          2026-07-27 00:00:00
          Application Docs ID
          86707
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          16
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          213674
          Review Priority
          STANDARD
          Submission Class Code ID
          12
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2020-08-04 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          213674
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2021-05-24 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          213674
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5
          Submission Status
          AP
          Submission Status Date
          2022-01-13 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          213674
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2022-09-09 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          213674
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          10
          Submission Status
          AP
          Submission Status Date
          2023-11-16 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          213674
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          11
          Submission Status
          AP
          Submission Status Date
          2025-01-22 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          213674
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          12
          Submission Status
          AP
          Submission Status Date
          2025-03-21 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          213674
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          15
          Submission Status
          AP
          Submission Status Date
          2025-12-11 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          213674
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          16
          Submission Status
          AP
          Submission Status Date
          2026-07-24 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA213674
        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
        2026-07-24
        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
          213674
          Application Docs Date
          2026-07-27 00:00:00
          Application Docs ID
          86707
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          16
          Submission Type
          SUPPL
        official application record
        Appl No
        213674
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        ASTELLAS
        openfda application present
        true
        products
        1. Active Ingredient
          ENZALUTAMIDE
          Appl No
          213674
          Drug Name
          XTANDI
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          40MG
          marketing status
          1. Prescription
        2. Active Ingredient
          ENZALUTAMIDE
          Appl No
          213674
          Drug Name
          XTANDI
          Form
          TABLET;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          1
          Strength
          80MG
          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. NDA203415
      2. NDA213674
      brand names
      1. Xtandi
      classification reasons
      1. explicit_positive_indication_predicate
      2. no_tumor_directed_keyword_in_positive_statement
      clinical review status
      pending
      content role
      positive_indication_candidate
      context span
      end
      281
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE XTANDI ® is indicated for the treatment of patients with: • castration-resistant prostate cancer (CRPC) • metastatic castration-sensitive prostate cancer (mCSPC) • non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with biochemical recurrence at h
      label id
      1cc0ed2a-2c33-4027-90bb-572d717b81d2
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      0f9a9a1fca37c99224e9443a63557ebaac95dfd1fcf71e43e6ef4dfc7157de6f
      start
      0
      current approval status
      not_reconciled
      duplicate text group
      dup-8e988e84319ffce23b15
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. ENZALUTAMIDE
      id
      ind-span-d7971f073585929e437f
      label id
      1cc0ed2a-2c33-4027-90bb-572d717b81d2
      positive predicate support span
      end
      45
      end exclusive
      true
      exact text
      is indicated
      label id
      1cc0ed2a-2c33-4027-90bb-572d717b81d2
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      0f9a9a1fca37c99224e9443a63557ebaac95dfd1fcf71e43e6ef4dfc7157de6f
      start
      33
      qualifier mentions
        regulatory links
          schema version
          0.1.0
          source batch sha256
          0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
          source defined aliases
            source span
            end
            81
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE XTANDI ® is indicated for the treatment of patients with:
            label id
            1cc0ed2a-2c33-4027-90bb-572d717b81d2
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            0f9a9a1fca37c99224e9443a63557ebaac95dfd1fcf71e43e6ef4dfc7157de6f
            start
            0
            source url
            https://api.fda.gov/drug/label.json?search=id%3A%221cc0ed2a-2c33-4027-90bb-572d717b81d2%22
            spl effective date
            2026-07-28
            spl set id
            b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf
            spl version
            24
            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
            non_oncology_or_unclear_candidate
            Passage 2 · unclassified context
            application numbers
            1. NDA203415
            2. NDA213674
            brand names
            1. Xtandi
            classification reasons
            1. no_unambiguous_positive_indication_predicate
            clinical review status
            pending
            content role
            unclassified_context
            context span
            end
            327
            end exclusive
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                                                risk BCR) XTANDI is an androgen receptor inhibitor indicated for the treatment of patients with: • castration-resistant prostate cancer. ( 1 ) • metastatic castration-sensitive prostate cancer. ( 1 ) • non‑metastatic castration‑sensitive prostate cancer with biochemical recurrence at high risk for metastasis. ( 1 )
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                                                    esistant prostate cancer. ( 1 ) • metastatic castration-sensitive prostate cancer. ( 1 ) • non‑metastatic castration‑sensitive prostate cancer with biochemical recurrence at high risk for metastasis. ( 1 )
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                                                          Preserved source evidence · Not medical advice