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

LABELS · 463bff67-d7cf-a132-e063-6394a90abe1d

AKEEGA

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
2025-12-18
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 AKEEGA with prednisone is indicated for the treatment of adult patients with deleterious or suspected deleterious BRCA2 -mutated ( BRCA2 m) metastatic castration-sensitive prostate cancer (mCSPC). AKEEGA with prednisone is indicated for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved test for AKEEGA [see Dosage and Administration (2.1) ] . AKEEGA is a combination of niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, a CYP17 inhibitor indicated with prednisone for the treatment of adult patients with: deleterious or suspected deleterious BRCA2 -mutated ( BRCA2 m) metastatic castration-sensitive prostate cancer (mCSPC). deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved test for AKEEGA. ( 1 , 2.1 )
Full extracted label fields
application numbers
  1. NDA216793
boxed warning exact
    brand names
    1. AKEEGA
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8245a990-3268-4613-b5c5-9537858a1eb9
    generic names
    1. NIRAPARIB TOSYLATE MONOHYDRATE AND ABIRATERONE ACETATE
    id
    463bff67-d7cf-a132-e063-6394a90abe1d
    indications and usage exact
    1. 1 INDICATIONS AND USAGE AKEEGA with prednisone is indicated for the treatment of adult patients with deleterious or suspected deleterious BRCA2 -mutated ( BRCA2 m) metastatic castration-sensitive prostate cancer (mCSPC). AKEEGA with prednisone is indicated for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved test for AKEEGA [see Dosage and Administration (2.1) ] . AKEEGA is a combination of niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, a CYP17 inhibitor indicated with prednisone for the treatment of adult patients with: deleterious or suspected deleterious BRCA2 -mutated ( BRCA2 m) metastatic castration-sensitive prostate cancer (mCSPC). deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved test for AKEEGA. ( 1 , 2.1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Janssen Biotech, Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 57894-100-60
      2. 57894-050-60
      product ndcs
      1. 57894-050
      2. 57894-100
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Indications and Usage ( 1 ) 12/2025 Dosage and Administration ( 2.1 , 2.2 ) 12/2025 Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 ) 12/2025
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 2645244
      2. 2645250
      3. 2645251
      4. 2645253
      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%22463bff67-d7cf-a132-e063-6394a90abe1d%22
      spl effective date
      2025-12-18
      spl effective time
      20251218
      spl set id
      8245a990-3268-4613-b5c5-9537858a1eb9
      spl version
      3
      substance names
      1. NIRAPARIB TOSYLATE MONOHYDRATE
      2. ABIRATERONE ACETATE
      uniis
      1. EM5OCB9YJ6
      2. 195Q483UZD
      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
        NDA216793
        payload
        all indexed label documents
        1. Appl No
          216793
          Application Docs Date
          2023-08-14 00:00:00
          Application Docs ID
          75056
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          216793
          Application Docs Date
          2025-12-18 00:00:00
          Application Docs ID
          84447
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          216793
          Review Priority
          PRIORITY
          Submission Class Code ID
          14
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2023-08-11 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          216793
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2025-12-12 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA216793
        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
        2025-12-12
        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
          216793
          Application Docs Date
          2025-12-18 00:00:00
          Application Docs ID
          84447
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        official application record
        Appl No
        216793
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        JANSSEN BIOTECH
        openfda application present
        true
        products
        1. Active Ingredient
          ABIRATERONE ACETATE; NIRAPARIB TOSYLATE
          Appl No
          216793
          Drug Name
          AKEEGA
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          500MG;EQ 50MG BASE
          marketing status
          1. Prescription
        2. Active Ingredient
          ABIRATERONE ACETATE; NIRAPARIB TOSYLATE
          Appl No
          216793
          Drug Name
          AKEEGA
          Form
          TABLET;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          1
          Strength
          500MG;EQ 100MG BASE
          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. NDA216793
      brand names
      1. AKEEGA
      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
      420
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE AKEEGA with prednisone is indicated for the treatment of adult patients with deleterious or suspected deleterious BRCA2 -mutated ( BRCA2 m) metastatic castration-sensitive prostate cancer (mCSPC). AKEEGA with prednisone is indicated for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Sele
      label id
      463bff67-d7cf-a132-e063-6394a90abe1d
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      b9d7542dcaf4db106f2d34a480986d970fba653390816893c4d3b3dd336aa441
      start
      0
      current approval status
      not_reconciled
      duplicate text group
      dup-ccc5cdadceaba397e73b
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. NIRAPARIB TOSYLATE MONOHYDRATE AND ABIRATERONE ACETATE
      id
      ind-span-215e6ee1d16010e500cd
      label id
      463bff67-d7cf-a132-e063-6394a90abe1d
      positive predicate support span
      end
      59
      end exclusive
      true
      exact text
      is indicated
      label id
      463bff67-d7cf-a132-e063-6394a90abe1d
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      b9d7542dcaf4db106f2d34a480986d970fba653390816893c4d3b3dd336aa441
      start
      47
      qualifier mentions
      1. context exact
        GE AKEEGA with prednisone is indicated for the treatment of adult patients with deleterious or suspected deleterious BRCA2 -mutated (
        kind
        age
        polarity
        not_inferred
        span
        end
        95
        end exclusive
        true
        exact text
        adult patients
        label id
        463bff67-d7cf-a132-e063-6394a90abe1d
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        b9d7542dcaf4db106f2d34a480986d970fba653390816893c4d3b3dd336aa441
        start
        81
      2. context exact
        of adult patients with deleterious or suspected deleterious BRCA2 -mutated ( BRCA2 m) metastatic castration-sensitive prostate cancer (mCSPC).
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        183
        end exclusive
        true
        exact text
        BRCA2 -mutated ( BRCA2 m) metastatic castrati
        label id
        463bff67-d7cf-a132-e063-6394a90abe1d
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        b9d7542dcaf4db106f2d34a480986d970fba653390816893c4d3b3dd336aa441
        start
        138
      3. context exact
        eterious or suspected deleterious BRCA2 -mutated ( BRCA2 m) metastatic castration-sensitive prostate cancer (mCSPC).
        kind
        stage_or_setting
        polarity
        not_inferred
        span
        end
        209
        end exclusive
        true
        exact text
        metastatic castration-sensitive prostate canc
        label id
        463bff67-d7cf-a132-e063-6394a90abe1d
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        b9d7542dcaf4db106f2d34a480986d970fba653390816893c4d3b3dd336aa441
        start
        164
      regulatory links
        schema version
        0.1.0
        source batch sha256
        d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
        source defined aliases
          source span
          end
          220
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE AKEEGA with prednisone is indicated for the treatment of adult patients with deleterious or suspected deleterious BRCA2 -mutated ( BRCA2 m) metastatic castration-sensitive prostate cancer (mCSPC).
          label id
          463bff67-d7cf-a132-e063-6394a90abe1d
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          b9d7542dcaf4db106f2d34a480986d970fba653390816893c4d3b3dd336aa441
          start
          0
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%22463bff67-d7cf-a132-e063-6394a90abe1d%22
          spl effective date
          2025-12-18
          spl set id
          8245a990-3268-4613-b5c5-9537858a1eb9
          spl version
          3
          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 · positive indication candidate
          application numbers
          1. NDA216793
          brand names
          1. AKEEGA
          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
          615
          end exclusive
          true
          exact text
          GE AKEEGA with prednisone is indicated for the treatment of adult patients with deleterious or suspected deleterious BRCA2 -mutated ( BRCA2 m) metastatic castration-sensitive prostate cancer (mCSPC). AKEEGA with prednisone is indicated for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved test for AKEEGA [see Dosage and Administration (2.1) ] . AKEEGA is a combination of niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, an
          label id
          463bff67-d7cf-a132-e063-6394a90abe1d
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          b9d7542dcaf4db106f2d34a480986d970fba653390816893c4d3b3dd336aa441
          start
          21
          current approval status
          not_reconciled
          duplicate text group
          dup-b077261d4b946f513325
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. NIRAPARIB TOSYLATE MONOHYDRATE AND ABIRATERONE ACETATE
          id
          ind-span-0ab7d3cbbd0284aea258
          label id
          463bff67-d7cf-a132-e063-6394a90abe1d
          positive predicate support span
          end
          256
          end exclusive
          true
          exact text
          is indicated
          label id
          463bff67-d7cf-a132-e063-6394a90abe1d
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          b9d7542dcaf4db106f2d34a480986d970fba653390816893c4d3b3dd336aa441
          start
          244
          qualifier mentions
          1. context exact
            AKEEGA with prednisone is indicated for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( B
            kind
            age
            polarity
            not_inferred
            span
            end
            292
            end exclusive
            true
            exact text
            adult patients
            label id
            463bff67-d7cf-a132-e063-6394a90abe1d
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            b9d7542dcaf4db106f2d34a480986d970fba653390816893c4d3b3dd336aa441
            start
            278
          2. context exact
            of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC).
            kind
            biomarker
            polarity
            not_inferred
            span
            end
            379
            end exclusive
            true
            exact text
            BRCA -mutated ( BRCA m) metastatic castratio
            label id
            463bff67-d7cf-a132-e063-6394a90abe1d
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            b9d7542dcaf4db106f2d34a480986d970fba653390816893c4d3b3dd336aa441
            start
            335
          3. context exact
            eleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC).
            kind
            stage_or_setting
            polarity
            not_inferred
            span
            end
            404
            end exclusive
            true
            exact text
            metastatic castration-resistant prostate canc
            label id
            463bff67-d7cf-a132-e063-6394a90abe1d
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            b9d7542dcaf4db106f2d34a480986d970fba653390816893c4d3b3dd336aa441
            start
            359
          regulatory links
            schema version
            0.1.0
            source batch sha256
            d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
            source defined aliases
              source span
              end
              415
              end exclusive
              true
              exact text
              AKEEGA with prednisone is indicated for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC).
              label id
              463bff67-d7cf-a132-e063-6394a90abe1d
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              b9d7542dcaf4db106f2d34a480986d970fba653390816893c4d3b3dd336aa441
              start
              221
              source url
              https://api.fda.gov/drug/label.json?search=id%3A%22463bff67-d7cf-a132-e063-6394a90abe1d%22
              spl effective date
              2025-12-18
              spl set id
              8245a990-3268-4613-b5c5-9537858a1eb9
              spl version
              3
              structured fields status
              not_extracted_no_values_inferred_from_mentions
              structured indication
              age
              Source null
              approval pathway
              Source null
              biomarker and test
              Source null
              disease stage
              Source null
              limitations
              Source null
              line
              Source null
              prior therapy
              Source null
              regimen
              Source null
              tumor histology
              Source null
              use intent
              tumor_directed_candidate
              Passage 3 · unclassified context
              application numbers
              1. NDA216793
              brand names
              1. AKEEGA
              classification reasons
              1. no_unambiguous_positive_indication_predicate
              clinical review status
              pending
              content role
              unclassified_context
              context span
              end
              725
              end exclusive
              true
              exact text
              PC). AKEEGA with prednisone is indicated for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved test for AKEEGA [see Dosage and Administration (2.1) ] . AKEEGA is a combination of niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, a CYP17 inhibitor indicated with prednisone for the treatment of adult patients with: d
              label id
              463bff67-d7cf-a132-e063-6394a90abe1d
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              b9d7542dcaf4db106f2d34a480986d970fba653390816893c4d3b3dd336aa441
              start
              216
              current approval status
              not_reconciled
              duplicate text group
              dup-a956d090893a3f77434f
              extraction review status
              automated_candidate_pending_source_review
              generic names
              1. NIRAPARIB TOSYLATE MONOHYDRATE AND ABIRATERONE ACETATE
              id
              ind-span-464fd855e826a9f4ef26
              label id
              463bff67-d7cf-a132-e063-6394a90abe1d
              positive predicate support span
              Source null
              qualifier mentions
                regulatory links
                  schema version
                  0.1.0
                  source batch sha256
                  d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                  source defined aliases
                    source span
                    end
                    525
                    end exclusive
                    true
                    exact text
                    Select patients for therapy based on an FDA-approved test for AKEEGA [see Dosage and Administration (2.1) ] .
                    label id
                    463bff67-d7cf-a132-e063-6394a90abe1d
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    b9d7542dcaf4db106f2d34a480986d970fba653390816893c4d3b3dd336aa441
                    start
                    416
                    source url
                    https://api.fda.gov/drug/label.json?search=id%3A%22463bff67-d7cf-a132-e063-6394a90abe1d%22
                    spl effective date
                    2025-12-18
                    spl set id
                    8245a990-3268-4613-b5c5-9537858a1eb9
                    spl version
                    3
                    structured fields status
                    not_extracted_no_values_inferred_from_mentions
                    structured indication
                    age
                    Source null
                    approval pathway
                    Source null
                    biomarker and test
                    Source null
                    disease stage
                    Source null
                    limitations
                    Source null
                    line
                    Source null
                    prior therapy
                    Source null
                    regimen
                    Source null
                    tumor histology
                    Source null
                    use intent
                    unclear
                    Passage 4 · unclassified context
                    application numbers
                    1. NDA216793
                    brand names
                    1. AKEEGA
                    classification reasons
                    1. no_unambiguous_positive_indication_predicate
                    clinical review status
                    pending
                    content role
                    unclassified_context
                    context span
                    end
                    1043
                    end exclusive
                    true
                    exact text
                    eterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved test for AKEEGA [see Dosage and Administration (2.1) ] . AKEEGA is a combination of niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, a CYP17 inhibitor indicated with prednisone for the treatment of adult patients with: deleterious or suspected deleterious BRCA2 -mutated ( BRCA2 m) metastatic castration-sensitive prostate cancer (mCSPC). deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved test for AKEEGA. ( 1 , 2.1 )
                    label id
                    463bff67-d7cf-a132-e063-6394a90abe1d
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    b9d7542dcaf4db106f2d34a480986d970fba653390816893c4d3b3dd336aa441
                    start
                    326
                    current approval status
                    not_reconciled
                    duplicate text group
                    dup-2affe736c4eaeb5fe8a0
                    extraction review status
                    automated_candidate_pending_source_review
                    generic names
                    1. NIRAPARIB TOSYLATE MONOHYDRATE AND ABIRATERONE ACETATE
                    id
                    ind-span-4f3085472ade73c73fea
                    label id
                    463bff67-d7cf-a132-e063-6394a90abe1d
                    positive predicate support span
                    Source null
                    qualifier mentions
                    1. context exact
                      17 inhibitor indicated with prednisone for the treatment of adult patients with: deleterious or suspected deleterious BRCA2 -mutated (
                      kind
                      age
                      polarity
                      not_inferred
                      span
                      end
                      717
                      end exclusive
                      true
                      exact text
                      adult patients
                      label id
                      463bff67-d7cf-a132-e063-6394a90abe1d
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      b9d7542dcaf4db106f2d34a480986d970fba653390816893c4d3b3dd336aa441
                      start
                      703
                    2. context exact
                      f adult patients with: deleterious or suspected deleterious BRCA2 -mutated ( BRCA2 m) metastatic castration-sensitive prostate cancer (mCSPC). deleterious or suspect
                      kind
                      biomarker
                      polarity
                      not_inferred
                      span
                      end
                      806
                      end exclusive
                      true
                      exact text
                      BRCA2 -mutated ( BRCA2 m) metastatic castrati
                      label id
                      463bff67-d7cf-a132-e063-6394a90abe1d
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      b9d7542dcaf4db106f2d34a480986d970fba653390816893c4d3b3dd336aa441
                      start
                      761
                    3. context exact
                      ostate cancer (mCSPC). deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC).
                      kind
                      biomarker
                      polarity
                      not_inferred
                      span
                      end
                      925
                      end exclusive
                      true
                      exact text
                      BRCA -mutated ( BRCA m) metastatic castratio
                      label id
                      463bff67-d7cf-a132-e063-6394a90abe1d
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      b9d7542dcaf4db106f2d34a480986d970fba653390816893c4d3b3dd336aa441
                      start
                      881
                    4. context exact
                      eterious or suspected deleterious BRCA2 -mutated ( BRCA2 m) metastatic castration-sensitive prostate cancer (mCSPC). deleterious or suspected deleterious BRCA -mutat
                      kind
                      stage_or_setting
                      polarity
                      not_inferred
                      span
                      end
                      832
                      end exclusive
                      true
                      exact text
                      metastatic castration-sensitive prostate canc
                      label id
                      463bff67-d7cf-a132-e063-6394a90abe1d
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      b9d7542dcaf4db106f2d34a480986d970fba653390816893c4d3b3dd336aa441
                      start
                      787
                    5. context exact
                      eleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC).
                      kind
                      stage_or_setting
                      polarity
                      not_inferred
                      span
                      end
                      950
                      end exclusive
                      true
                      exact text
                      metastatic castration-resistant prostate canc
                      label id
                      463bff67-d7cf-a132-e063-6394a90abe1d
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      b9d7542dcaf4db106f2d34a480986d970fba653390816893c4d3b3dd336aa441
                      start
                      905
                    regulatory links
                      schema version
                      0.1.0
                      source batch sha256
                      d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                      source defined aliases
                        source span
                        end
                        961
                        end exclusive
                        true
                        exact text
                        AKEEGA is a combination of niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, and abiraterone acetate, a CYP17 inhibitor indicated with prednisone for the treatment of adult patients with: deleterious or suspected deleterious BRCA2 -mutated ( BRCA2 m) metastatic castration-sensitive prostate cancer (mCSPC). deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC).
                        label id
                        463bff67-d7cf-a132-e063-6394a90abe1d
                        offset unit
                        unicode_code_points
                        source array index
                        0
                        source field
                        indications_and_usage_exact
                        source text sha256
                        b9d7542dcaf4db106f2d34a480986d970fba653390816893c4d3b3dd336aa441
                        start
                        526
                        source url
                        https://api.fda.gov/drug/label.json?search=id%3A%22463bff67-d7cf-a132-e063-6394a90abe1d%22
                        spl effective date
                        2025-12-18
                        spl set id
                        8245a990-3268-4613-b5c5-9537858a1eb9
                        spl version
                        3
                        structured fields status
                        not_extracted_no_values_inferred_from_mentions
                        structured indication
                        age
                        Source null
                        approval pathway
                        Source null
                        biomarker and test
                        Source null
                        disease stage
                        Source null
                        limitations
                        Source null
                        line
                        Source null
                        prior therapy
                        Source null
                        regimen
                        Source null
                        tumor histology
                        Source null
                        use intent
                        unclear
                        Passage 5 · unclassified context
                        application numbers
                        1. NDA216793
                        brand names
                        1. AKEEGA
                        classification reasons
                        1. no_unambiguous_positive_indication_predicate
                        clinical review status
                        pending
                        content role
                        unclassified_context
                        context span
                        end
                        1043
                        end exclusive
                        true
                        exact text
                        RCA2 -mutated ( BRCA2 m) metastatic castration-sensitive prostate cancer (mCSPC). deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved test for AKEEGA. ( 1 , 2.1 )
                        label id
                        463bff67-d7cf-a132-e063-6394a90abe1d
                        offset unit
                        unicode_code_points
                        source array index
                        0
                        source field
                        indications_and_usage_exact
                        source text sha256
                        b9d7542dcaf4db106f2d34a480986d970fba653390816893c4d3b3dd336aa441
                        start
                        762
                        current approval status
                        not_reconciled
                        duplicate text group
                        dup-ebd27fdb50afee224a7b
                        extraction review status
                        automated_candidate_pending_source_review
                        generic names
                        1. NIRAPARIB TOSYLATE MONOHYDRATE AND ABIRATERONE ACETATE
                        id
                        ind-span-74f78385f1edecfb9d73
                        label id
                        463bff67-d7cf-a132-e063-6394a90abe1d
                        positive predicate support span
                        Source null
                        qualifier mentions
                          regulatory links
                            schema version
                            0.1.0
                            source batch sha256
                            d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                            source defined aliases
                              source span
                              end
                              1031
                              end exclusive
                              true
                              exact text
                              Select patients for therapy based on an FDA-approved test for AKEEGA.
                              label id
                              463bff67-d7cf-a132-e063-6394a90abe1d
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              b9d7542dcaf4db106f2d34a480986d970fba653390816893c4d3b3dd336aa441
                              start
                              962
                              source url
                              https://api.fda.gov/drug/label.json?search=id%3A%22463bff67-d7cf-a132-e063-6394a90abe1d%22
                              spl effective date
                              2025-12-18
                              spl set id
                              8245a990-3268-4613-b5c5-9537858a1eb9
                              spl version
                              3
                              structured fields status
                              not_extracted_no_values_inferred_from_mentions
                              structured indication
                              age
                              Source null
                              approval pathway
                              Source null
                              biomarker and test
                              Source null
                              disease stage
                              Source null
                              limitations
                              Source null
                              line
                              Source null
                              prior therapy
                              Source null
                              regimen
                              Source null
                              tumor histology
                              Source null
                              use intent
                              unclear
                              Passage 6 · unclassified context
                              application numbers
                              1. NDA216793
                              brand names
                              1. AKEEGA
                              classification reasons
                              1. no_unambiguous_positive_indication_predicate
                              clinical review status
                              pending
                              content role
                              unclassified_context
                              context span
                              end
                              1043
                              end exclusive
                              true
                              exact text
                              er (mCSPC). deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved test for AKEEGA. ( 1 , 2.1 )
                              label id
                              463bff67-d7cf-a132-e063-6394a90abe1d
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              b9d7542dcaf4db106f2d34a480986d970fba653390816893c4d3b3dd336aa441
                              start
                              832
                              current approval status
                              not_reconciled
                              duplicate text group
                              dup-2fc709b9486c13089773
                              extraction review status
                              automated_candidate_pending_source_review
                              generic names
                              1. NIRAPARIB TOSYLATE MONOHYDRATE AND ABIRATERONE ACETATE
                              id
                              ind-span-099b43a15be6b9d28fa4
                              label id
                              463bff67-d7cf-a132-e063-6394a90abe1d
                              positive predicate support span
                              Source null
                              qualifier mentions
                                regulatory links
                                  schema version
                                  0.1.0
                                  source batch sha256
                                  d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                                  source defined aliases
                                    source span
                                    end
                                    1043
                                    end exclusive
                                    true
                                    exact text
                                    ( 1 , 2.1 )
                                    label id
                                    463bff67-d7cf-a132-e063-6394a90abe1d
                                    offset unit
                                    unicode_code_points
                                    source array index
                                    0
                                    source field
                                    indications_and_usage_exact
                                    source text sha256
                                    b9d7542dcaf4db106f2d34a480986d970fba653390816893c4d3b3dd336aa441
                                    start
                                    1032
                                    source url
                                    https://api.fda.gov/drug/label.json?search=id%3A%22463bff67-d7cf-a132-e063-6394a90abe1d%22
                                    spl effective date
                                    2025-12-18
                                    spl set id
                                    8245a990-3268-4613-b5c5-9537858a1eb9
                                    spl version
                                    3
                                    structured fields status
                                    not_extracted_no_values_inferred_from_mentions
                                    structured indication
                                    age
                                    Source null
                                    approval pathway
                                    Source null
                                    biomarker and test
                                    Source null
                                    disease stage
                                    Source null
                                    limitations
                                    Source null
                                    line
                                    Source null
                                    prior therapy
                                    Source null
                                    regimen
                                    Source null
                                    tumor histology
                                    Source null
                                    use intent
                                    unclear

                                    Preserved source evidence · Not medical advice