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

LABELS · c853d4c8-8373-4603-bc62-41e53130c0aa

PHYRAGO

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
2025-08-23
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1. INDICATIONS AND USAGE PHYRAGO is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. PHYRAGO is indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy. PHYRAGO TM is a kinase inhibitor indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. ( 1 , 14 ) adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. ( 1 , 14 ) adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. ( 1 , 14 ) pediatric patients 1 year of age and older with Ph+ CML in chronic phase. ( 1 , 14 ) pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy. ( 1 , 14 )
Full extracted label fields
application numbers
  1. NDA216099
boxed warning exact
    brand names
    1. PHYRAGO
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=60976d1e-c415-417f-8168-4e07999a7281
    generic names
    1. DASATINIB
    id
    c853d4c8-8373-4603-bc62-41e53130c0aa
    indications and usage exact
    1. 1. INDICATIONS AND USAGE PHYRAGO is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. PHYRAGO is indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy. PHYRAGO TM is a kinase inhibitor indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. ( 1 , 14 ) adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. ( 1 , 14 ) adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. ( 1 , 14 ) pediatric patients 1 year of age and older with Ph+ CML in chronic phase. ( 1 , 14 ) pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy. ( 1 , 14 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Cycle Pharmaceuticals Ltd
      matched search terms
      1. leukemia
      package ndcs
      1. 70709-151-20
      2. 70709-152-50
      3. 70709-153-70
      4. 70709-154-80
      5. 70709-155-10
      6. 70709-156-14
      product ndcs
      1. 70709-151
      2. 70709-152
      3. 70709-153
      4. 70709-154
      5. 70709-155
      6. 70709-156
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. RECENT MAJOR CHANGES Indications and Usage ( 1 ) 8/2025 Dosage and Administration ( 2.2 , 2.3 , 2.4 , 2.5 ) 8/2025 Warnings and Precautions ( 5.1 , 5.3 ) 8/2025
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 643105
      2. 643107
      3. 643109
      4. 799047
      5. 1045402
      6. 1045406
      7. 2691837
      8. 2691839
      9. 2691841
      10. 2691843
      11. 2691845
      12. 2691847
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00600.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
      600
      total
      830
      sha256
      a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
      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=600&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%22c853d4c8-8373-4603-bc62-41e53130c0aa%22
      spl effective date
      2025-08-23
      spl effective time
      20250823
      spl set id
      60976d1e-c415-417f-8168-4e07999a7281
      spl version
      3
      substance names
      1. DASATINIB
      uniis
      1. RBZ1571X5H
      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
        NDA216099
        payload
        all indexed label documents
        1. Appl No
          216099
          Application Docs Date
          2023-12-06 00:00:00
          Application Docs ID
          76742
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          216099
          Application Docs Date
          2024-08-02 00:00:00
          Application Docs ID
          79283
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        3. Appl No
          216099
          Application Docs Date
          2024-12-05 00:00:00
          Application Docs ID
          80524
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        4. Appl No
          216099
          Application Docs Date
          2025-08-04 00:00:00
          Application Docs ID
          83038
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          216099
          Review Priority
          STANDARD
          Submission Class Code ID
          15
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2023-12-05 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          216099
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2024-12-03 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          216099
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          2024-07-31 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          216099
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          5
          Submission Status
          AP
          Submission Status Date
          2025-08-01 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA216099
        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
        2025-08-01
        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
          216099
          Application Docs Date
          2025-08-04 00:00:00
          Application Docs ID
          83038
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
          SUPPL
        official application record
        Appl No
        216099
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        HANDA THERAP
        openfda application present
        true
        products
        1. Active Ingredient
          DASATINIB
          Appl No
          216099
          Drug Name
          PHYRAGO
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          20MG
          marketing status
          1. Prescription
        2. Active Ingredient
          DASATINIB
          Appl No
          216099
          Drug Name
          PHYRAGO
          Form
          TABLET;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          0
          Strength
          50MG
          marketing status
          1. Prescription
        3. Active Ingredient
          DASATINIB
          Appl No
          216099
          Drug Name
          PHYRAGO
          Form
          TABLET;ORAL
          Product No
          003
          Reference Drug
          1
          Reference Standard
          0
          Strength
          70MG
          marketing status
          1. Prescription
        4. Active Ingredient
          DASATINIB
          Appl No
          216099
          Drug Name
          PHYRAGO
          Form
          TABLET;ORAL
          Product No
          004
          Reference Drug
          1
          Reference Standard
          0
          Strength
          80MG
          marketing status
          1. Prescription
        5. Active Ingredient
          DASATINIB
          Appl No
          216099
          Drug Name
          PHYRAGO
          Form
          TABLET;ORAL
          Product No
          005
          Reference Drug
          1
          Reference Standard
          1
          Strength
          100MG
          marketing status
          1. Prescription
        6. Active Ingredient
          DASATINIB
          Appl No
          216099
          Drug Name
          PHYRAGO
          Form
          TABLET;ORAL
          Product No
          006
          Reference Drug
          1
          Reference Standard
          0
          Strength
          140MG
          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 · unclassified context
      application numbers
      1. NDA216099
      brand names
      1. PHYRAGO
      classification reasons
      1. no_unambiguous_positive_indication_predicate
      clinical review status
      pending
      content role
      unclassified_context
      context span
      end
      202
      end exclusive
      true
      exact text
      1. INDICATIONS AND USAGE PHYRAGO is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, ac
      label id
      c853d4c8-8373-4603-bc62-41e53130c0aa
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
      start
      0
      current approval status
      not_reconciled
      duplicate text group
      dup-4c68d8fe979ce8f5f22b
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. DASATINIB
      id
      ind-span-cc099e9afa4675d782d0
      label id
      c853d4c8-8373-4603-bc62-41e53130c0aa
      positive predicate support span
      Source null
      qualifier mentions
        regulatory links
          schema version
          0.1.0
          source batch sha256
          a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
          source defined aliases
            source span
            end
            2
            end exclusive
            true
            exact text
            1.
            label id
            c853d4c8-8373-4603-bc62-41e53130c0aa
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
            start
            0
            source url
            https://api.fda.gov/drug/label.json?search=id%3A%22c853d4c8-8373-4603-bc62-41e53130c0aa%22
            spl effective date
            2025-08-23
            spl set id
            60976d1e-c415-417f-8168-4e07999a7281
            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 2 · positive indication candidate
            application numbers
            1. NDA216099
            brand names
            1. PHYRAGO
            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
            523
            end exclusive
            true
            exact text
            1. INDICATIONS AND USAGE PHYRAGO is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. PHYRAGO is indicated for the treatment of pediatric patients 1 year of age and
            label id
            c853d4c8-8373-4603-bc62-41e53130c0aa
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
            start
            0
            current approval status
            not_reconciled
            duplicate text group
            dup-c859ea4c62710f898184
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. DASATINIB
            id
            ind-span-25cfbe8fa988426854c7
            label id
            c853d4c8-8373-4603-bc62-41e53130c0aa
            positive predicate support span
            end
            45
            end exclusive
            true
            exact text
            is indicated
            label id
            c853d4c8-8373-4603-bc62-41e53130c0aa
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
            start
            33
            qualifier mentions
            1. context exact
              CATIONS AND USAGE PHYRAGO is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+)
              kind
              age
              polarity
              not_inferred
              span
              end
              81
              end exclusive
              true
              exact text
              adult patients
              label id
              c853d4c8-8373-4603-bc62-41e53130c0aa
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
              start
              67
            regulatory links
              schema version
              0.1.0
              source batch sha256
              a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
              source defined aliases
                source span
                end
                323
                end exclusive
                true
                exact text
                INDICATIONS AND USAGE PHYRAGO is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib.
                label id
                c853d4c8-8373-4603-bc62-41e53130c0aa
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
                start
                3
                source url
                https://api.fda.gov/drug/label.json?search=id%3A%22c853d4c8-8373-4603-bc62-41e53130c0aa%22
                spl effective date
                2025-08-23
                spl set id
                60976d1e-c415-417f-8168-4e07999a7281
                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. NDA216099
                brand names
                1. PHYRAGO
                classification reasons
                1. no_unambiguous_positive_indication_predicate
                clinical review status
                pending
                content role
                unclassified_context
                context span
                end
                644
                end exclusive
                true
                exact text
                me-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. PHYRAGO is indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy. PHYRAGO TM is a kinase in
                label id
                c853d4c8-8373-4603-bc62-41e53130c0aa
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
                start
                124
                current approval status
                not_reconciled
                duplicate text group
                dup-cbba27800d3492825c6f
                extraction review status
                automated_candidate_pending_source_review
                generic names
                1. DASATINIB
                id
                ind-span-7e03190101f51be452d7
                label id
                c853d4c8-8373-4603-bc62-41e53130c0aa
                positive predicate support span
                Source null
                qualifier mentions
                  regulatory links
                    schema version
                    0.1.0
                    source batch sha256
                    a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                    source defined aliases
                      source span
                      end
                      444
                      end exclusive
                      true
                      exact text
                      Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.
                      label id
                      c853d4c8-8373-4603-bc62-41e53130c0aa
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
                      start
                      324
                      source url
                      https://api.fda.gov/drug/label.json?search=id%3A%22c853d4c8-8373-4603-bc62-41e53130c0aa%22
                      spl effective date
                      2025-08-23
                      spl set id
                      60976d1e-c415-417f-8168-4e07999a7281
                      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 · positive indication candidate
                      application numbers
                      1. NDA216099
                      brand names
                      1. PHYRAGO
                      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
                      818
                      end exclusive
                      true
                      exact text
                      se Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. PHYRAGO is indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy. PHYRAGO TM is a kinase inhibitor indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. ( 1 , 14 ) adults w
                      label id
                      c853d4c8-8373-4603-bc62-41e53130c0aa
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
                      start
                      245
                      current approval status
                      not_reconciled
                      duplicate text group
                      dup-d34272c4b7dcfe2016d7
                      extraction review status
                      automated_candidate_pending_source_review
                      generic names
                      1. DASATINIB
                      id
                      ind-span-4619e7eb8ede07197baa
                      label id
                      c853d4c8-8373-4603-bc62-41e53130c0aa
                      positive predicate support span
                      end
                      465
                      end exclusive
                      true
                      exact text
                      is indicated
                      label id
                      c853d4c8-8373-4603-bc62-41e53130c0aa
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
                      start
                      453
                      qualifier mentions
                      1. context exact
                        PHYRAGO is indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newl
                        kind
                        age
                        polarity
                        not_inferred
                        span
                        end
                        505
                        end exclusive
                        true
                        exact text
                        pediatric patients
                        label id
                        c853d4c8-8373-4603-bc62-41e53130c0aa
                        offset unit
                        unicode_code_points
                        source array index
                        0
                        source field
                        indications_and_usage_exact
                        source text sha256
                        5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
                        start
                        487
                      2. context exact
                        lder with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy.
                        kind
                        regimen
                        polarity
                        not_inferred
                        span
                        end
                        617
                        end exclusive
                        true
                        exact text
                        in combination with chemotherapy
                        label id
                        c853d4c8-8373-4603-bc62-41e53130c0aa
                        offset unit
                        unicode_code_points
                        source array index
                        0
                        source field
                        indications_and_usage_exact
                        source text sha256
                        5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
                        start
                        585
                      regulatory links
                        schema version
                        0.1.0
                        source batch sha256
                        a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                        source defined aliases
                          source span
                          end
                          618
                          end exclusive
                          true
                          exact text
                          PHYRAGO is indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy.
                          label id
                          c853d4c8-8373-4603-bc62-41e53130c0aa
                          offset unit
                          unicode_code_points
                          source array index
                          0
                          source field
                          indications_and_usage_exact
                          source text sha256
                          5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
                          start
                          445
                          source url
                          https://api.fda.gov/drug/label.json?search=id%3A%22c853d4c8-8373-4603-bc62-41e53130c0aa%22
                          spl effective date
                          2025-08-23
                          spl set id
                          60976d1e-c415-417f-8168-4e07999a7281
                          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 5 · positive indication candidate
                          application numbers
                          1. NDA216099
                          brand names
                          1. PHYRAGO
                          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
                          998
                          end exclusive
                          true
                          exact text
                          lerance to prior therapy. PHYRAGO is indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy. PHYRAGO TM is a kinase inhibitor indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. ( 1 , 14 ) adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. ( 1 , 14 ) adults with Philadelphia chromos
                          label id
                          c853d4c8-8373-4603-bc62-41e53130c0aa
                          offset unit
                          unicode_code_points
                          source array index
                          0
                          source field
                          indications_and_usage_exact
                          source text sha256
                          5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
                          start
                          419
                          current approval status
                          not_reconciled
                          duplicate text group
                          dup-308e748b2b915c82810d
                          extraction review status
                          automated_candidate_pending_source_review
                          generic names
                          1. DASATINIB
                          id
                          ind-span-353f2997995b10e59018
                          label id
                          c853d4c8-8373-4603-bc62-41e53130c0aa
                          positive predicate support span
                          end
                          661
                          end exclusive
                          true
                          exact text
                          is a kinase inhibitor indicated
                          label id
                          c853d4c8-8373-4603-bc62-41e53130c0aa
                          offset unit
                          unicode_code_points
                          source array index
                          0
                          source field
                          indications_and_usage_exact
                          source text sha256
                          5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
                          start
                          630
                          qualifier mentions
                          1. context exact
                            se inhibitor indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid
                            kind
                            age
                            polarity
                            not_inferred
                            span
                            end
                            705
                            end exclusive
                            true
                            exact text
                            adults
                            label id
                            c853d4c8-8373-4603-bc62-41e53130c0aa
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
                            start
                            699
                          regulatory links
                            schema version
                            0.1.0
                            source batch sha256
                            a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                            source defined aliases
                              source span
                              end
                              798
                              end exclusive
                              true
                              exact text
                              PHYRAGO TM is a kinase inhibitor indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
                              label id
                              c853d4c8-8373-4603-bc62-41e53130c0aa
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
                              start
                              619
                              source url
                              https://api.fda.gov/drug/label.json?search=id%3A%22c853d4c8-8373-4603-bc62-41e53130c0aa%22
                              spl effective date
                              2025-08-23
                              spl set id
                              60976d1e-c415-417f-8168-4e07999a7281
                              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 6 · unclassified context
                              application numbers
                              1. NDA216099
                              brand names
                              1. PHYRAGO
                              classification reasons
                              1. no_unambiguous_positive_indication_predicate
                              clinical review status
                              pending
                              content role
                              unclassified_context
                              context span
                              end
                              1154
                              end exclusive
                              true
                              exact text
                              with chemotherapy. PHYRAGO TM is a kinase inhibitor indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. ( 1 , 14 ) adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. ( 1 , 14 ) adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. ( 1 , 14 ) pediatric patients 1 year of age and older w
                              label id
                              c853d4c8-8373-4603-bc62-41e53130c0aa
                              offset unit
                              unicode_code_points
                              source array index
                              0
                              source field
                              indications_and_usage_exact
                              source text sha256
                              5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
                              start
                              599
                              current approval status
                              not_reconciled
                              duplicate text group
                              dup-4d5809e431eac01c78c5
                              extraction review status
                              automated_candidate_pending_source_review
                              generic names
                              1. DASATINIB
                              id
                              ind-span-15c6b5668821e7c86736
                              label id
                              c853d4c8-8373-4603-bc62-41e53130c0aa
                              positive predicate support span
                              Source null
                              qualifier mentions
                              1. context exact
                                ( 1 , 14 ) adults with chronic, accelerated, or myeloid or lymphoid blast pha
                                kind
                                age
                                polarity
                                not_inferred
                                span
                                end
                                816
                                end exclusive
                                true
                                exact text
                                adults
                                label id
                                c853d4c8-8373-4603-bc62-41e53130c0aa
                                offset unit
                                unicode_code_points
                                source array index
                                0
                                source field
                                indications_and_usage_exact
                                source text sha256
                                5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
                                start
                                810
                              regulatory links
                                schema version
                                0.1.0
                                source batch sha256
                                a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                                source defined aliases
                                  source span
                                  end
                                  954
                                  end exclusive
                                  true
                                  exact text
                                  ( 1 , 14 ) adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib.
                                  label id
                                  c853d4c8-8373-4603-bc62-41e53130c0aa
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
                                  start
                                  799
                                  source url
                                  https://api.fda.gov/drug/label.json?search=id%3A%22c853d4c8-8373-4603-bc62-41e53130c0aa%22
                                  spl effective date
                                  2025-08-23
                                  spl set id
                                  60976d1e-c415-417f-8168-4e07999a7281
                                  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 7 · unclassified context
                                  application numbers
                                  1. NDA216099
                                  brand names
                                  1. PHYRAGO
                                  classification reasons
                                  1. no_unambiguous_positive_indication_predicate
                                  clinical review status
                                  pending
                                  content role
                                  unclassified_context
                                  context span
                                  end
                                  1298
                                  end exclusive
                                  true
                                  exact text
                                  ic myeloid leukemia (CML) in chronic phase. ( 1 , 14 ) adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. ( 1 , 14 ) adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. ( 1 , 14 ) pediatric patients 1 year of age and older with Ph+ CML in chronic phase. ( 1 , 14 ) pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherap
                                  label id
                                  c853d4c8-8373-4603-bc62-41e53130c0aa
                                  offset unit
                                  unicode_code_points
                                  source array index
                                  0
                                  source field
                                  indications_and_usage_exact
                                  source text sha256
                                  5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
                                  start
                                  755
                                  current approval status
                                  not_reconciled
                                  duplicate text group
                                  dup-aa89537e993f378d23c8
                                  extraction review status
                                  automated_candidate_pending_source_review
                                  generic names
                                  1. DASATINIB
                                  id
                                  ind-span-77b2f93586d5cbf8e928
                                  label id
                                  c853d4c8-8373-4603-bc62-41e53130c0aa
                                  positive predicate support span
                                  Source null
                                  qualifier mentions
                                  1. context exact
                                    ( 1 , 14 ) adults with Philadelphia chromosome-positive acute lymphoblastic l
                                    kind
                                    age
                                    polarity
                                    not_inferred
                                    span
                                    end
                                    972
                                    end exclusive
                                    true
                                    exact text
                                    adults
                                    label id
                                    c853d4c8-8373-4603-bc62-41e53130c0aa
                                    offset unit
                                    unicode_code_points
                                    source array index
                                    0
                                    source field
                                    indications_and_usage_exact
                                    source text sha256
                                    5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
                                    start
                                    966
                                  regulatory links
                                    schema version
                                    0.1.0
                                    source batch sha256
                                    a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                                    source defined aliases
                                      source span
                                      end
                                      1098
                                      end exclusive
                                      true
                                      exact text
                                      ( 1 , 14 ) adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.
                                      label id
                                      c853d4c8-8373-4603-bc62-41e53130c0aa
                                      offset unit
                                      unicode_code_points
                                      source array index
                                      0
                                      source field
                                      indications_and_usage_exact
                                      source text sha256
                                      5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
                                      start
                                      955
                                      source url
                                      https://api.fda.gov/drug/label.json?search=id%3A%22c853d4c8-8373-4603-bc62-41e53130c0aa%22
                                      spl effective date
                                      2025-08-23
                                      spl set id
                                      60976d1e-c415-417f-8168-4e07999a7281
                                      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 8 · unclassified context
                                      application numbers
                                      1. NDA216099
                                      brand names
                                      1. PHYRAGO
                                      classification reasons
                                      1. no_unambiguous_positive_indication_predicate
                                      clinical review status
                                      pending
                                      content role
                                      unclassified_context
                                      context span
                                      end
                                      1311
                                      end exclusive
                                      true
                                      exact text
                                      nce or intolerance to prior therapy including imatinib. ( 1 , 14 ) adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. ( 1 , 14 ) pediatric patients 1 year of age and older with Ph+ CML in chronic phase. ( 1 , 14 ) pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy. ( 1 , 14 )
                                      label id
                                      c853d4c8-8373-4603-bc62-41e53130c0aa
                                      offset unit
                                      unicode_code_points
                                      source array index
                                      0
                                      source field
                                      indications_and_usage_exact
                                      source text sha256
                                      5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
                                      start
                                      899
                                      current approval status
                                      not_reconciled
                                      duplicate text group
                                      dup-b408cfb0cbb1c7d7e10b
                                      extraction review status
                                      automated_candidate_pending_source_review
                                      generic names
                                      1. DASATINIB
                                      id
                                      ind-span-4b5aa3478d4b3f403bed
                                      label id
                                      c853d4c8-8373-4603-bc62-41e53130c0aa
                                      positive predicate support span
                                      Source null
                                      qualifier mentions
                                      1. context exact
                                        ( 1 , 14 ) pediatric patients 1 year of age and older with Ph+ CML in chronic phase.
                                        kind
                                        age
                                        polarity
                                        not_inferred
                                        span
                                        end
                                        1128
                                        end exclusive
                                        true
                                        exact text
                                        pediatric patients
                                        label id
                                        c853d4c8-8373-4603-bc62-41e53130c0aa
                                        offset unit
                                        unicode_code_points
                                        source array index
                                        0
                                        source field
                                        indications_and_usage_exact
                                        source text sha256
                                        5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
                                        start
                                        1110
                                      regulatory links
                                        schema version
                                        0.1.0
                                        source batch sha256
                                        a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                                        source defined aliases
                                          source span
                                          end
                                          1183
                                          end exclusive
                                          true
                                          exact text
                                          ( 1 , 14 ) pediatric patients 1 year of age and older with Ph+ CML in chronic phase.
                                          label id
                                          c853d4c8-8373-4603-bc62-41e53130c0aa
                                          offset unit
                                          unicode_code_points
                                          source array index
                                          0
                                          source field
                                          indications_and_usage_exact
                                          source text sha256
                                          5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
                                          start
                                          1099
                                          source url
                                          https://api.fda.gov/drug/label.json?search=id%3A%22c853d4c8-8373-4603-bc62-41e53130c0aa%22
                                          spl effective date
                                          2025-08-23
                                          spl set id
                                          60976d1e-c415-417f-8168-4e07999a7281
                                          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 9 · unclassified context
                                          application numbers
                                          1. NDA216099
                                          brand names
                                          1. PHYRAGO
                                          classification reasons
                                          1. no_unambiguous_positive_indication_predicate
                                          clinical review status
                                          pending
                                          content role
                                          unclassified_context
                                          context span
                                          end
                                          1311
                                          end exclusive
                                          true
                                          exact text
                                          elphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. ( 1 , 14 ) pediatric patients 1 year of age and older with Ph+ CML in chronic phase. ( 1 , 14 ) pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy. ( 1 , 14 )
                                          label id
                                          c853d4c8-8373-4603-bc62-41e53130c0aa
                                          offset unit
                                          unicode_code_points
                                          source array index
                                          0
                                          source field
                                          indications_and_usage_exact
                                          source text sha256
                                          5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
                                          start
                                          984
                                          current approval status
                                          not_reconciled
                                          duplicate text group
                                          dup-23a95414bdf67dcf2efa
                                          extraction review status
                                          automated_candidate_pending_source_review
                                          generic names
                                          1. DASATINIB
                                          id
                                          ind-span-62d2854135da85c51867
                                          label id
                                          c853d4c8-8373-4603-bc62-41e53130c0aa
                                          positive predicate support span
                                          Source null
                                          qualifier mentions
                                          1. context exact
                                            ( 1 , 14 ) pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in com
                                            kind
                                            age
                                            polarity
                                            not_inferred
                                            span
                                            end
                                            1213
                                            end exclusive
                                            true
                                            exact text
                                            pediatric patients
                                            label id
                                            c853d4c8-8373-4603-bc62-41e53130c0aa
                                            offset unit
                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
                                            start
                                            1195
                                          2. context exact
                                            tients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy.
                                            kind
                                            regimen
                                            polarity
                                            not_inferred
                                            span
                                            end
                                            1299
                                            end exclusive
                                            true
                                            exact text
                                            in combination with chemotherapy
                                            label id
                                            c853d4c8-8373-4603-bc62-41e53130c0aa
                                            offset unit
                                            unicode_code_points
                                            source array index
                                            0
                                            source field
                                            indications_and_usage_exact
                                            source text sha256
                                            5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
                                            start
                                            1267
                                          regulatory links
                                            schema version
                                            0.1.0
                                            source batch sha256
                                            a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                                            source defined aliases
                                              source span
                                              end
                                              1300
                                              end exclusive
                                              true
                                              exact text
                                              ( 1 , 14 ) pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy.
                                              label id
                                              c853d4c8-8373-4603-bc62-41e53130c0aa
                                              offset unit
                                              unicode_code_points
                                              source array index
                                              0
                                              source field
                                              indications_and_usage_exact
                                              source text sha256
                                              5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
                                              start
                                              1184
                                              source url
                                              https://api.fda.gov/drug/label.json?search=id%3A%22c853d4c8-8373-4603-bc62-41e53130c0aa%22
                                              spl effective date
                                              2025-08-23
                                              spl set id
                                              60976d1e-c415-417f-8168-4e07999a7281
                                              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 10 · unclassified context
                                              application numbers
                                              1. NDA216099
                                              brand names
                                              1. PHYRAGO
                                              classification reasons
                                              1. no_unambiguous_positive_indication_predicate
                                              clinical review status
                                              pending
                                              content role
                                              unclassified_context
                                              context span
                                              end
                                              1311
                                              end exclusive
                                              true
                                              exact text
                                              1 , 14 ) pediatric patients 1 year of age and older with Ph+ CML in chronic phase. ( 1 , 14 ) pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy. ( 1 , 14 )
                                              label id
                                              c853d4c8-8373-4603-bc62-41e53130c0aa
                                              offset unit
                                              unicode_code_points
                                              source array index
                                              0
                                              source field
                                              indications_and_usage_exact
                                              source text sha256
                                              5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
                                              start
                                              1101
                                              current approval status
                                              not_reconciled
                                              duplicate text group
                                              dup-ff5dc31f21088e405dd2
                                              extraction review status
                                              automated_candidate_pending_source_review
                                              generic names
                                              1. DASATINIB
                                              id
                                              ind-span-3cf8d51bd70d707fe7d1
                                              label id
                                              c853d4c8-8373-4603-bc62-41e53130c0aa
                                              positive predicate support span
                                              Source null
                                              qualifier mentions
                                                regulatory links
                                                  schema version
                                                  0.1.0
                                                  source batch sha256
                                                  a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
                                                  source defined aliases
                                                    source span
                                                    end
                                                    1311
                                                    end exclusive
                                                    true
                                                    exact text
                                                    ( 1 , 14 )
                                                    label id
                                                    c853d4c8-8373-4603-bc62-41e53130c0aa
                                                    offset unit
                                                    unicode_code_points
                                                    source array index
                                                    0
                                                    source field
                                                    indications_and_usage_exact
                                                    source text sha256
                                                    5ea8738e0f85dd04a552154f1b4fc0df0e3d7be44f7038804dc53f98615f9151
                                                    start
                                                    1301
                                                    source url
                                                    https://api.fda.gov/drug/label.json?search=id%3A%22c853d4c8-8373-4603-bc62-41e53130c0aa%22
                                                    spl effective date
                                                    2025-08-23
                                                    spl set id
                                                    60976d1e-c415-417f-8168-4e07999a7281
                                                    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