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LABELS · 810ce789-bff1-42b9-aef7-1f92f0dde727

Lorbrena

Open original source → · Download preserved record

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

Label effective date
2026-02-13
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE LORBRENA ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. LORBRENA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. ( 1 , 2.1 )
Full extracted label fields
application numbers
  1. NDA210868
boxed warning exact
    brand names
    1. Lorbrena
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=004f93d7-a1cd-4b67-9207-31cdcb5c5976
    generic names
    1. LORLATINIB
    id
    810ce789-bff1-42b9-aef7-1f92f0dde727
    indications and usage exact
    1. 1 INDICATIONS AND USAGE LORBRENA ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. LORBRENA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. ( 1 , 2.1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. U.S. Pharmaceuticals
      matched search terms
      1. cancer
      2. lymphoma
      3. tumors
      package ndcs
      1. 63539-927-01
      product ndcs
      1. 63539-927
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Dosage Modifications for Drug Interactions ( 2.4 ) 1/2026 Recommended Dosage for Severe Hepatic Impairment ( 2.5 ) 1/2026 Recommended Dosage for Renal Impairment ( 2.6 ) 1/2026
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 2103169
      2. 2103175
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00400.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
      400
      total
      830
      sha256
      a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
      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=400&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%22810ce789-bff1-42b9-aef7-1f92f0dde727%22
      spl effective date
      2026-02-13
      spl effective time
      20260213
      spl set id
      004f93d7-a1cd-4b67-9207-31cdcb5c5976
      spl version
      3
      substance names
      1. LORLATINIB
      uniis
      1. OSP71S83EU
      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
        NDA210868
        payload
        all indexed label documents
        1. Appl No
          210868
          Application Docs Date
          2018-11-02 00:00:00
          Application Docs ID
          56252
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          210868
          Application Docs Date
          2020-06-02 00:00:00
          Application Docs ID
          63390
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        3. Appl No
          210868
          Application Docs Date
          2021-01-26 00:00:00
          Application Docs ID
          66001
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        4. Appl No
          210868
          Application Docs Date
          2021-03-01 00:00:00
          Application Docs ID
          66435
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        5. Appl No
          210868
          Application Docs Date
          2021-03-03 00:00:00
          Application Docs ID
          66478
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        6. Appl No
          210868
          Application Docs Date
          2025-09-30 00:00:00
          Application Docs ID
          83606
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        7. Appl No
          210868
          Application Docs Date
          2026-02-05 00:00:00
          Application Docs ID
          84946
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          8
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          210868
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2018-11-02 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          210868
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2020-05-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          210868
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2021-01-22 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          210868
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2021-02-26 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          210868
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          2021-03-03 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          210868
          Review Priority
          N/A
          Submission Class Code ID
          4
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2025-02-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          210868
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          8
          Submission Status
          AP
          Submission Status Date
          2026-01-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA210868
        approval interpretation
        Application linkage and approved submission are not indication-level current approval verification
        current indication status
        not_reconciled
        has approved submission record
        true
        latest approved submission date
        2026-01-29
        latest label selection rule
        max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
        latest posted label documents
        1. Appl No
          210868
          Application Docs Date
          2026-02-05 00:00:00
          Application Docs ID
          84946
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          8
          Submission Type
          SUPPL
        official application record
        Appl No
        210868
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        PFIZER
        openfda application present
        true
        products
        1. Active Ingredient
          LORLATINIB
          Appl No
          210868
          Drug Name
          LORBRENA
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          25MG
          marketing status
          1. Prescription
        2. Active Ingredient
          LORLATINIB
          Appl No
          210868
          Drug Name
          LORBRENA
          Form
          TABLET;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          1
          Strength
          100MG
          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. NDA210868
      brand names
      1. Lorbrena
      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
      430
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE LORBRENA ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. LORBRENA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected
      label id
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      offset unit
      unicode_code_points
      source array index
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      source field
      indications_and_usage_exact
      source text sha256
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      start
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      current approval status
      not_reconciled
      duplicate text group
      dup-e532d1ed9e09bfa885df
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. LORLATINIB
      id
      ind-span-5d41adfd0a63f6eeac5f
      label id
      810ce789-bff1-42b9-aef7-1f92f0dde727
      positive predicate support span
      end
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      end exclusive
      true
      exact text
      is indicated
      label id
      810ce789-bff1-42b9-aef7-1f92f0dde727
      offset unit
      unicode_code_points
      source array index
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      source field
      indications_and_usage_exact
      source text sha256
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      start
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      qualifier mentions
      1. context exact
        IONS AND USAGE LORBRENA ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tu
        kind
        age
        polarity
        not_inferred
        span
        end
        83
        end exclusive
        true
        exact text
        adult patients
        label id
        810ce789-bff1-42b9-aef7-1f92f0dde727
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        4c37c6b6dc3f366aac97ba341ff792b116b0f0e4cb18f4f66e8024f3fcb8fa6b
        start
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      2. context exact
        ENA ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positiv
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        132
        end exclusive
        true
        exact text
        metastatic non-small cell lung cancer (NSCL
        label id
        810ce789-bff1-42b9-aef7-1f92f0dde727
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
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      3. context exact
        cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        223
        end exclusive
        true
        exact text
        ALK)-positive as detected by an FDA-approve
        label id
        810ce789-bff1-42b9-aef7-1f92f0dde727
        offset unit
        unicode_code_points
        source array index
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        source field
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        source text sha256
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      4. context exact
        ENA ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive
        kind
        stage_or_setting
        polarity
        not_inferred
        span
        end
        134
        end exclusive
        true
        exact text
        metastatic non-small cell lung cancer (NSCLC)
        label id
        810ce789-bff1-42b9-aef7-1f92f0dde727
        offset unit
        unicode_code_points
        source array index
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        source field
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        source text sha256
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      regulatory links
        schema version
        0.1.0
        source batch sha256
        a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
        source defined aliases
        1. abbreviation
          NSCLC
          definition exact
          non-small cell lung cancer
          definition span
          end
          134
          end exclusive
          true
          exact text
          non-small cell lung cancer (NSCLC)
          label id
          810ce789-bff1-42b9-aef7-1f92f0dde727
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
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        source span
        end
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        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE LORBRENA ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
        label id
        810ce789-bff1-42b9-aef7-1f92f0dde727
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
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        start
        0
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22810ce789-bff1-42b9-aef7-1f92f0dde727%22
        spl effective date
        2026-02-13
        spl set id
        004f93d7-a1cd-4b67-9207-31cdcb5c5976
        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. NDA210868
        brand names
        1. Lorbrena
        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
        466
        end exclusive
        true
        exact text
        A ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. LORBRENA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. ( 1 , 2.1 )
        label id
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        offset unit
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        source field
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        source text sha256
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        current approval status
        not_reconciled
        duplicate text group
        dup-2f82508bfa2e4af99fff
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. LORLATINIB
        id
        ind-span-fa3cd3884c91ece20476
        label id
        810ce789-bff1-42b9-aef7-1f92f0dde727
        positive predicate support span
        end
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        end exclusive
        true
        exact text
        is a kinase inhibitor indicated
        label id
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        offset unit
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        qualifier mentions
        1. context exact
          RBRENA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tu
          kind
          age
          polarity
          not_inferred
          span
          end
          307
          end exclusive
          true
          exact text
          adult patients
          label id
          810ce789-bff1-42b9-aef7-1f92f0dde727
          offset unit
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        2. context exact
          nhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positiv
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          356
          end exclusive
          true
          exact text
          metastatic non-small cell lung cancer (NSCL
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          offset unit
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        3. context exact
          cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          447
          end exclusive
          true
          exact text
          ALK)-positive as detected by an FDA-approve
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          start
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        4. context exact
          nhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive
          kind
          stage_or_setting
          polarity
          not_inferred
          span
          end
          358
          end exclusive
          true
          exact text
          metastatic non-small cell lung cancer (NSCLC)
          label id
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          offset unit
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        regulatory links
          schema version
          0.1.0
          source batch sha256
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          source defined aliases
          1. abbreviation
            NSCLC
            definition exact
            non-small cell lung cancer
            definition span
            end
            134
            end exclusive
            true
            exact text
            non-small cell lung cancer (NSCLC)
            label id
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            offset unit
            unicode_code_points
            source array index
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            source field
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            source text sha256
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            start
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          source span
          end
          454
          end exclusive
          true
          exact text
          LORBRENA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
          label id
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          offset unit
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          source array index
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          source field
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          source text sha256
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          source url
          https://api.fda.gov/drug/label.json?search=id%3A%22810ce789-bff1-42b9-aef7-1f92f0dde727%22
          spl effective date
          2026-02-13
          spl set id
          004f93d7-a1cd-4b67-9207-31cdcb5c5976
          spl version
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          structured fields status
          not_extracted_no_values_inferred_from_mentions
          structured indication
          age
          Source null
          approval pathway
          Source null
          biomarker and test
          Source null
          disease stage
          Source null
          limitations
          Source null
          line
          Source null
          prior therapy
          Source null
          regimen
          Source null
          tumor histology
          Source null
          use intent
          tumor_directed_candidate
          Passage 3 · unclassified context
          application numbers
          1. NDA210868
          brand names
          1. Lorbrena
          classification reasons
          1. no_unambiguous_positive_indication_predicate
          clinical review status
          pending
          content role
          unclassified_context
          context span
          end
          466
          end exclusive
          true
          exact text
          ibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. ( 1 , 2.1 )
          label id
          810ce789-bff1-42b9-aef7-1f92f0dde727
          offset unit
          unicode_code_points
          source array index
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          source field
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          source text sha256
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          start
          255
          current approval status
          not_reconciled
          duplicate text group
          dup-831d329ccd7a8acb66c4
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. LORLATINIB
          id
          ind-span-83a120086a5b72a4bb28
          label id
          810ce789-bff1-42b9-aef7-1f92f0dde727
          positive predicate support span
          Source null
          qualifier mentions
            regulatory links
              schema version
              0.1.0
              source batch sha256
              a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
              source defined aliases
              1. abbreviation
                NSCLC
                definition exact
                non-small cell lung cancer
                definition span
                end
                134
                end exclusive
                true
                exact text
                non-small cell lung cancer (NSCLC)
                label id
                810ce789-bff1-42b9-aef7-1f92f0dde727
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                4c37c6b6dc3f366aac97ba341ff792b116b0f0e4cb18f4f66e8024f3fcb8fa6b
                start
                100
              source span
              end
              466
              end exclusive
              true
              exact text
              ( 1 , 2.1 )
              label id
              810ce789-bff1-42b9-aef7-1f92f0dde727
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              4c37c6b6dc3f366aac97ba341ff792b116b0f0e4cb18f4f66e8024f3fcb8fa6b
              start
              455
              source url
              https://api.fda.gov/drug/label.json?search=id%3A%22810ce789-bff1-42b9-aef7-1f92f0dde727%22
              spl effective date
              2026-02-13
              spl set id
              004f93d7-a1cd-4b67-9207-31cdcb5c5976
              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