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LABELS · da4a9239-16d7-46cf-b089-e943e0080015

LAZCLUZE

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
2026-05-05
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE LAZCLUZE, in combination with amivantamab, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test [see Dosage and Administration (2.1) ] . LAZCLUZE is a kinase inhibitor indicated in combination with amivantamab for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. ( 1 )
Full extracted label fields
application numbers
  1. NDA219008
boxed warning exact
    brand names
    1. LAZCLUZE
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c417f9ee-2027-4ed5-92ad-3c19266de16c
    generic names
    1. LAZERTINIB
    id
    da4a9239-16d7-46cf-b089-e943e0080015
    indications and usage exact
    1. 1 INDICATIONS AND USAGE LAZCLUZE, in combination with amivantamab, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test [see Dosage and Administration (2.1) ] . LAZCLUZE is a kinase inhibitor indicated in combination with amivantamab for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Janssen Biotech, Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 57894-240-30
      2. 57894-240-99
      3. 57894-080-60
      4. 57894-080-90
      product ndcs
      1. 57894-080
      2. 57894-240
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Dosage and Administration ( 2.3 , 2.4 ) 04/2026 Warnings and Precautions ( 5.3 , 5.4 ) 04/2026
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 2691156
      2. 2691162
      3. 2691164
      4. 2691166
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00700.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
      700
      total
      830
      sha256
      24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
      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=700&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%22da4a9239-16d7-46cf-b089-e943e0080015%22
      spl effective date
      2026-05-05
      spl effective time
      20260505
      spl set id
      c417f9ee-2027-4ed5-92ad-3c19266de16c
      spl version
      6
      substance names
      1. LAZERTINIB
      uniis
      1. 4A2Y23XK11
      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
        NDA219008
        payload
        all indexed label documents
        1. Appl No
          219008
          Application Docs Date
          2024-08-20 00:00:00
          Application Docs ID
          79439
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          219008
          Application Docs Date
          2025-11-12 00:00:00
          Application Docs ID
          84140
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        3. Appl No
          219008
          Application Docs Date
          2026-05-05 00:00:00
          Application Docs ID
          85841
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          219008
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2024-08-19 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          219008
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2025-08-14 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          219008
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2025-11-07 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          219008
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          2026-04-30 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA219008
        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
        2026-04-30
        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
          219008
          Application Docs Date
          2026-05-05 00:00:00
          Application Docs ID
          85841
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        official application record
        Appl No
        219008
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        JANSSEN BIOTECH
        openfda application present
        true
        products
        1. Active Ingredient
          LAZERTINIB MESYLATE
          Appl No
          219008
          Drug Name
          LAZCLUZE
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          EQ 80MG BASE
          marketing status
          1. Prescription
        2. Active Ingredient
          LAZERTINIB MESYLATE
          Appl No
          219008
          Drug Name
          LAZCLUZE
          Form
          TABLET;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 240MG 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. NDA219008
      brand names
      1. LAZCLUZE
      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
      578
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE LAZCLUZE, in combination with amivantamab, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test [see Dosage and Administration (2.1) ] . LAZCLUZE is a kinase inhibitor indicated in combination with amivantamab for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epi
      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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      current approval status
      not_reconciled
      duplicate text group
      dup-b829addd86c9acb41e92
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. LAZERTINIB
      id
      ind-span-005599c93b75878da64d
      label id
      da4a9239-16d7-46cf-b089-e943e0080015
      positive predicate support span
      end
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      end exclusive
      true
      exact text
      is indicated
      label id
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      qualifier mentions
      1. context exact
        h amivantamab, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung can
        kind
        age
        polarity
        not_inferred
        span
        end
        126
        end exclusive
        true
        exact text
        adult patients
        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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      2. context exact
        t-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 dele
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        195
        end exclusive
        true
        exact text
        metastatic non-small cell lung cancer (NSCL
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        source field
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        source text sha256
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      3. context exact
        lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test [se
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        281
        end exclusive
        true
        exact text
        EGFR) exon 19 deletions or exon 21 L858R sub
        label id
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        offset unit
        unicode_code_points
        source array index
        0
        source field
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        source text sha256
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        start
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      4. context exact
        dicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)
        kind
        stage_or_setting
        polarity
        not_inferred
        span
        end
        183
        end exclusive
        true
        exact text
        locally advanced or metastatic non-small cell lung
        label id
        da4a9239-16d7-46cf-b089-e943e0080015
        offset unit
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        source text sha256
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      5. context exact
        LUZE, in combination with amivantamab, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by a
        kind
        prior_therapy_or_line
        polarity
        not_inferred
        span
        end
        258
        end exclusive
        true
        exact text
        first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletio
        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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      6. context exact
        1 INDICATIONS AND USAGE LAZCLUZE, in combination with amivantamab, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L
        kind
        regimen
        polarity
        not_inferred
        span
        end
        213
        end exclusive
        true
        exact text
        in combination with amivantamab, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal
        label id
        da4a9239-16d7-46cf-b089-e943e0080015
        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
        24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
        source defined aliases
        1. abbreviation
          NSCLC
          definition exact
          non-small cell lung cancer
          definition span
          end
          197
          end exclusive
          true
          exact text
          non-small cell lung cancer (NSCLC)
          label id
          da4a9239-16d7-46cf-b089-e943e0080015
          offset unit
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          source field
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          source text sha256
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        source span
        end
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        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE LAZCLUZE, in combination with amivantamab, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test [see Dosage and Administration (2.1) ] .
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        start
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        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22da4a9239-16d7-46cf-b089-e943e0080015%22
        spl effective date
        2026-05-05
        spl set id
        c417f9ee-2027-4ed5-92ad-3c19266de16c
        spl version
        6
        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. NDA219008
        brand names
        1. LAZCLUZE
        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
        716
        end exclusive
        true
        exact text
        ung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test [see Dosage and Administration (2.1) ] . LAZCLUZE is a kinase inhibitor indicated in combination with amivantamab for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. ( 1 )
        label id
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        current approval status
        not_reconciled
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        id
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        label id
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        positive predicate support span
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        end exclusive
        true
        exact text
        is a kinase inhibitor indicated
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        qualifier mentions
        1. context exact
          ombination with amivantamab for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung can
          kind
          age
          polarity
          not_inferred
          span
          end
          498
          end exclusive
          true
          exact text
          adult patients
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          offset unit
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        2. context exact
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          span
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          end exclusive
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          offset unit
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        3. context exact
          lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
          kind
          biomarker
          polarity
          not_inferred
          span
          end
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          exact text
          EGFR) exon 19 deletions or exon 21 L858R sub
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          offset unit
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        4. context exact
          antamab for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)
          kind
          stage_or_setting
          polarity
          not_inferred
          span
          end
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          end exclusive
          true
          exact text
          locally advanced or metastatic non-small cell lung
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          offset unit
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        5. context exact
          inhibitor indicated in combination with amivantamab for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by a
          kind
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          polarity
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          span
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          630
          end exclusive
          true
          exact text
          first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletio
          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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        6. context exact
          LAZCLUZE is a kinase inhibitor indicated in combination with amivantamab for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitut
          kind
          regimen
          polarity
          not_inferred
          span
          end
          599
          end exclusive
          true
          exact text
          in combination with amivantamab for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor
          label id
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          offset unit
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          LAZCLUZE is a kinase inhibitor indicated in combination with amivantamab for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
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          advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. ( 1 )
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              Preserved source evidence · Not medical advice