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LABELS · 3159555e-f227-4168-9e96-96f5b705fad2

ALECENSA

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
2026-08-21
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE ALECENSA is a kinase inhibitor indicated for: adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive) as detected by an FDA-approved test. ( 1.1 ) treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test. ( 1.2 ) 1.1 Adjuvant Treatment of Resected ALK-Positive Non-Small Cell Lung Cancer (NSCLC) ALECENSA is indicated as adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive), as detected by an FDA-approved test [see Dosage & Administration (2.1) ]. 1.2 Treatment of Metastatic ALK-Positive NSCLC ALECENSA is indicated for the treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test [see Dosage & Administration (2.1) ] .
Full extracted label fields
application numbers
  1. NDA208434
boxed warning exact
    brand names
    1. ALECENSA
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=42c49deb-713b-427a-9670-08af08adcffb
    generic names
    1. ALECTINIB HYDROCHLORIDE
    id
    3159555e-f227-4168-9e96-96f5b705fad2
    indications and usage exact
    1. 1 INDICATIONS AND USAGE ALECENSA is a kinase inhibitor indicated for: adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive) as detected by an FDA-approved test. ( 1.1 ) treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test. ( 1.2 ) 1.1 Adjuvant Treatment of Resected ALK-Positive Non-Small Cell Lung Cancer (NSCLC) ALECENSA is indicated as adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive), as detected by an FDA-approved test [see Dosage & Administration (2.1) ]. 1.2 Treatment of Metastatic ALK-Positive NSCLC ALECENSA is indicated for the treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test [see Dosage & Administration (2.1) ] .
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Genentech, Inc.
      matched search terms
      1. cancer
      2. lymphoma
      3. tumor
      4. tumors
      package ndcs
      1. 50242-130-01
      2. 50242-130-86
      product ndcs
      1. 50242-130
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Dosage and Administration ( 2.4 ) 08/2026 Warnings and Precautions ( 5.7 ) 08/2026
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 1727479
      2. 1727485
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00100.json
      meta
      disclaimer
      Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
      last updated
      2026-09-09
      results
      limit
      100
      skip
      100
      total
      830
      sha256
      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
      url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=100&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%223159555e-f227-4168-9e96-96f5b705fad2%22
      spl effective date
      2026-08-21
      spl effective time
      20260821
      spl set id
      42c49deb-713b-427a-9670-08af08adcffb
      spl version
      29
      substance names
      1. ALECTINIB HYDROCHLORIDE
      uniis
      1. P9YY73LO6J
      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
        NDA208434
        payload
        all indexed label documents
        1. Appl No
          208434
          Application Docs Date
          2015-12-11 00:00:00
          Application Docs ID
          19995
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          208434
          Application Docs Date
          2016-11-08 00:00:00
          Application Docs ID
          45846
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        3. Appl No
          208434
          Application Docs Date
          2017-11-06 00:00:00
          Application Docs ID
          50314
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        4. Appl No
          208434
          Application Docs Date
          2018-06-08 00:00:00
          Application Docs ID
          54485
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        5. Appl No
          208434
          Application Docs Date
          2021-02-01 00:00:00
          Application Docs ID
          66035
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          10
          Submission Type
          SUPPL
        6. Appl No
          208434
          Application Docs Date
          2021-09-10 00:00:00
          Application Docs ID
          68576
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          12
          Submission Type
          SUPPL
        7. Appl No
          208434
          Application Docs Date
          2024-04-19 00:00:00
          Application Docs ID
          78180
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          15
          Submission Type
          SUPPL
        8. Appl No
          208434
          Application Docs Date
          2026-07-15 00:00:00
          Application Docs ID
          86570
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          16
          Submission Type
          SUPPL
        9. Appl No
          208434
          Application Docs Date
          2026-08-18 00:00:00
          Application Docs ID
          86963
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          17
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          208434
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2015-12-11 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          208434
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2016-11-04 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          208434
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2017-11-06 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          208434
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          2018-06-05 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          208434
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          10
          Submission Status
          AP
          Submission Status Date
          2021-01-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          208434
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          12
          Submission Status
          AP
          Submission Status Date
          2021-09-03 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          208434
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          15
          Submission Status
          AP
          Submission Status Date
          2024-04-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          208434
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          16
          Submission Status
          AP
          Submission Status Date
          2026-06-11 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          208434
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          17
          Submission Status
          AP
          Submission Status Date
          2026-08-14 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA208434
        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
        2026-08-14
        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
          208434
          Application Docs Date
          2026-08-18 00:00:00
          Application Docs ID
          86963
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          17
          Submission Type
          SUPPL
        official application record
        Appl No
        208434
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        HOFFMANN-LA ROCHE
        openfda application present
        true
        products
        1. Active Ingredient
          ALECTINIB HYDROCHLORIDE
          Appl No
          208434
          Drug Name
          ALECENSA
          Form
          CAPSULE;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 150MG BASE
          marketing status
          1. Prescription

      Source passages and status connections

      Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

      Passage 1 · positive indication candidate
      application numbers
      1. NDA208434
      brand names
      1. ALECENSA
      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
      482
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE ALECENSA is a kinase inhibitor indicated for: adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive) as detected by an FDA-approved test. ( 1.1 ) treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test. ( 1.2 ) 1.1 Adjuvant Treatment of Resected ALK-Positive 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
      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-e16bb1494168a1c75831
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. ALECTINIB HYDROCHLORIDE
      id
      ind-span-a8384009f325f1ab6c93
      label id
      3159555e-f227-4168-9e96-96f5b705fad2
      positive predicate support span
      end
      64
      end exclusive
      true
      exact text
      is a kinase inhibitor indicated
      label id
      3159555e-f227-4168-9e96-96f5b705fad2
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
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      start
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      qualifier mentions
      1. context exact
        is a kinase inhibitor indicated for: adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (AL
        kind
        age
        polarity
        not_inferred
        span
        end
        106
        end exclusive
        true
        exact text
        adult patients
        label id
        3159555e-f227-4168-9e96-96f5b705fad2
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
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      2. context exact
        ts following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive) as detected by an FDA
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        207
        end exclusive
        true
        exact text
        ALK)-positive non-small cell lung cancer (N
        label id
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        offset unit
        unicode_code_points
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        source field
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        source text sha256
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        start
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      3. context exact
        ONS AND USAGE ALECENSA is a kinase inhibitor indicated for: adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-posi
        kind
        stage_or_setting
        polarity
        not_inferred
        span
        end
        113
        end exclusive
        true
        exact text
        adjuvant treatment in adult patients follow
        label id
        3159555e-f227-4168-9e96-96f5b705fad2
        offset unit
        unicode_code_points
        source array index
        0
        source field
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        source text sha256
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      regulatory links
        schema version
        0.1.0
        source batch sha256
        fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
        source defined aliases
        1. abbreviation
          NSCLC
          definition exact
          non-small cell lung cancer
          definition span
          end
          212
          end exclusive
          true
          exact text
          non-small cell lung cancer (NSCLC)
          label id
          3159555e-f227-4168-9e96-96f5b705fad2
          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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        source span
        end
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        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE ALECENSA is a kinase inhibitor indicated for: adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive) as detected by an FDA-approved test.
        label id
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        offset unit
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        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%223159555e-f227-4168-9e96-96f5b705fad2%22
        spl effective date
        2026-08-21
        spl set id
        42c49deb-713b-427a-9670-08af08adcffb
        spl version
        29
        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. NDA208434
        brand names
        1. ALECENSA
        classification reasons
        1. inherited_predicate_from_same_label_section_requires_review
        2. tumor_or_malignant_hematology_words_in_positive_statement
        clinical review status
        pending
        content role
        positive_indication_candidate
        context span
        end
        590
        end exclusive
        true
        exact text
        tment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive) as detected by an FDA-approved test. ( 1.1 ) treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test. ( 1.2 ) 1.1 Adjuvant Treatment of Resected ALK-Positive Non-Small Cell Lung Cancer (NSCLC) ALECENSA is indicated as adjuvant treatment in adult patients following tumor resection of anaplastic lympho
        label id
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        offset unit
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        source field
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        current approval status
        not_reconciled
        duplicate text group
        dup-5dd15726b47b5da1e41f
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. ALECTINIB HYDROCHLORIDE
        id
        ind-span-5059b8fe8c2ba57a92d5
        label id
        3159555e-f227-4168-9e96-96f5b705fad2
        positive predicate support span
        end
        64
        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
          ( 1.1 ) treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-ap
          kind
          age
          polarity
          not_inferred
          span
          end
          318
          end exclusive
          true
          exact text
          adult patients
          label id
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          source text sha256
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        2. context exact
          ( 1.1 ) treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test.
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          367
          end exclusive
          true
          exact text
          ALK-positive metastatic NSCLC as detected b
          label id
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        3. context exact
          ( 1.1 ) treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test.
          kind
          stage_or_setting
          polarity
          not_inferred
          span
          end
          382
          end exclusive
          true
          exact text
          metastatic NSCLC as detected by an FDA-approv
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        regulatory links
          schema version
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          source batch sha256
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          source defined aliases
          1. abbreviation
            NSCLC
            definition exact
            non-small cell lung cancer
            definition span
            end
            212
            end exclusive
            true
            exact text
            non-small cell lung cancer (NSCLC)
            label id
            3159555e-f227-4168-9e96-96f5b705fad2
            offset unit
            unicode_code_points
            source array index
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            source field
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          source span
          end
          390
          end exclusive
          true
          exact text
          ( 1.1 ) treatment of adult patients with ALK-positive metastatic NSCLC as detected by an FDA-approved test.
          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 url
          https://api.fda.gov/drug/label.json?search=id%3A%223159555e-f227-4168-9e96-96f5b705fad2%22
          spl effective date
          2026-08-21
          spl set id
          42c49deb-713b-427a-9670-08af08adcffb
          spl version
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