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LABELS · 3ffd0da1-5601-4ecc-a8fb-f484693cb4c5

Vizimpro

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
2026-06-23
Captured
2026-09-09T23:37:44.904352+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE VIZIMPRO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test [see Dosage and Administration (2.1) ] . VIZIMPRO is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. ( 1 )
Full extracted label fields
application numbers
  1. NDA211288
boxed warning exact
    brand names
    1. Vizimpro
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4ab27d2f-e385-4e9c-b324-fa69c10b855a
    generic names
    1. DACOMITINIB
    id
    3ffd0da1-5601-4ecc-a8fb-f484693cb4c5
    indications and usage exact
    1. 1 INDICATIONS AND USAGE VIZIMPRO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test [see Dosage and Administration (2.1) ] . VIZIMPRO is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion 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. Pfizer Laboratories Div Pfizer Inc
      matched search terms
      1. cancer
      package ndcs
      1. 0069-0197-30
      2. 0069-1198-30
      3. 0069-2299-30
      product ndcs
      1. 0069-0197
      2. 0069-1198
      3. 0069-2299
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. ORAL
        rxcuis
        1. 2058915
        2. 2058922
        3. 2058924
        4. 2058926
        5. 2058930
        6. 2058932
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00200.json
        meta
        disclaimer
        Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
        last updated
        2026-09-09
        results
        limit
        100
        skip
        200
        total
        830
        sha256
        d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
        url
        https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=200&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%223ffd0da1-5601-4ecc-a8fb-f484693cb4c5%22
        spl effective date
        2026-06-23
        spl effective time
        20260623
        spl set id
        4ab27d2f-e385-4e9c-b324-fa69c10b855a
        spl version
        9
        substance names
        1. DACOMITINIB
        uniis
        1. 5092U85G58
        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
          NDA211288
          payload
          all indexed label documents
          1. Appl No
            211288
            Application Docs Date
            2018-09-27 00:00:00
            Application Docs ID
            55639
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            211288
            Application Docs Date
            2020-12-23 00:00:00
            Application Docs ID
            65735
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            3
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            211288
            Review Priority
            PRIORITY
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2018-09-27 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            211288
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            3
            Submission Status
            AP
            Submission Status Date
            2020-12-18 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA211288
          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
          2020-12-18
          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
            211288
            Application Docs Date
            2020-12-23 00:00:00
            Application Docs ID
            65735
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            3
            Submission Type
            SUPPL
          official application record
          Appl No
          211288
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          PFIZER
          openfda application present
          true
          products
          1. Active Ingredient
            DACOMITINIB
            Appl No
            211288
            Drug Name
            VIZIMPRO
            Form
            TABLET;ORAL
            Product No
            001
            Reference Drug
            1
            Reference Standard
            0
            Strength
            15MG
            marketing status
            1. Discontinued
          2. Active Ingredient
            DACOMITINIB
            Appl No
            211288
            Drug Name
            VIZIMPRO
            Form
            TABLET;ORAL
            Product No
            002
            Reference Drug
            1
            Reference Standard
            0
            Strength
            30MG
            marketing status
            1. Discontinued
          3. Active Ingredient
            DACOMITINIB
            Appl No
            211288
            Drug Name
            VIZIMPRO
            Form
            TABLET;ORAL
            Product No
            003
            Reference Drug
            1
            Reference Standard
            0
            Strength
            45MG
            marketing status
            1. Discontinued

        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. NDA211288
        brand names
        1. Vizimpro
        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
        516
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE VIZIMPRO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test [see Dosage and Administration (2.1) ] . VIZIMPRO is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or e
        label id
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        offset unit
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        source array index
        0
        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-ee7ac9dafc3c452b1529
        extraction review status
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        generic names
        1. DACOMITINIB
        id
        ind-span-a3c914aa3bcbb39bc111
        label id
        3ffd0da1-5601-4ecc-a8fb-f484693cb4c5
        positive predicate support span
        end
        45
        end exclusive
        true
        exact text
        is indicated
        label id
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        offset unit
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        source array index
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        source field
        indications_and_usage_exact
        source text sha256
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        qualifier mentions
        1. context exact
          is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 dele
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          135
          end exclusive
          true
          exact text
          metastatic non-small cell lung cancer (NSCL
          label id
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          source text sha256
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        2. context exact
          lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test [see
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          221
          end exclusive
          true
          exact text
          EGFR) exon 19 deletion or exon 21 L858R subs
          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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        3. context exact
          is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deleti
          kind
          stage_or_setting
          polarity
          not_inferred
          span
          end
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          end exclusive
          true
          exact text
          metastatic non-small cell lung cancer (NSCLC)
          label id
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          source text sha256
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        4. context exact
          1 INDICATIONS AND USAGE VIZIMPRO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test [see Dos
          kind
          prior_therapy_or_line
          polarity
          not_inferred
          span
          end
          224
          end exclusive
          true
          exact text
          first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substit
          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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        regulatory links
          schema version
          0.1.0
          source batch sha256
          d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
          source defined aliases
          1. abbreviation
            NSCLC
            definition exact
            non-small cell lung cancer
            definition span
            end
            137
            end exclusive
            true
            exact text
            non-small cell lung cancer (NSCLC)
            label id
            3ffd0da1-5601-4ecc-a8fb-f484693cb4c5
            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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          source span
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          true
          exact text
          1 INDICATIONS AND USAGE VIZIMPRO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test [see Dosage and Administration (2.1) ] .
          label id
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          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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          source url
          https://api.fda.gov/drug/label.json?search=id%3A%223ffd0da1-5601-4ecc-a8fb-f484693cb4c5%22
          spl effective date
          2026-06-23
          spl set id
          4ab27d2f-e385-4e9c-b324-fa69c10b855a
          spl version
          9
          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. NDA211288
          brand names
          1. Vizimpro
          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
          594
          end exclusive
          true
          exact text
          lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test [see Dosage and Administration (2.1) ] . VIZIMPRO is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. ( 1 )
          label id
          3ffd0da1-5601-4ecc-a8fb-f484693cb4c5
          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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          current approval status
          not_reconciled
          duplicate text group
          dup-fd1c0135ecd1589d1d67
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. DACOMITINIB
          id
          ind-span-4a3ecb2f08fc39b64f78
          label id
          3ffd0da1-5601-4ecc-a8fb-f484693cb4c5
          positive predicate support span
          end
          357
          end exclusive
          true
          exact text
          is a kinase inhibitor indicated
          label id
          3ffd0da1-5601-4ecc-a8fb-f484693cb4c5
          offset unit
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          source field
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          qualifier mentions
          1. context exact
            tor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 dele
            kind
            biomarker
            polarity
            not_inferred
            span
            end
            447
            end exclusive
            true
            exact text
            metastatic non-small cell lung cancer (NSCL
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            kind
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            polarity
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            true
            exact text
            EGFR) exon 19 deletion or exon 21 L858R subs
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          3. context exact
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            kind
            stage_or_setting
            polarity
            not_inferred
            span
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            end exclusive
            true
            exact text
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          4. context exact
            VIZIMPRO is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.
            kind
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          regulatory links
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            source defined aliases
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              definition exact
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              end
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              end exclusive
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              exact text
              non-small cell lung cancer (NSCLC)
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            exact text
            VIZIMPRO is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.
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            source url
            https://api.fda.gov/drug/label.json?search=id%3A%223ffd0da1-5601-4ecc-a8fb-f484693cb4c5%22
            spl effective date
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            spl set id
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            spl version
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            structured fields status
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            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. NDA211288
            brand names
            1. Vizimpro
            classification reasons
            1. no_unambiguous_positive_indication_predicate
            clinical review status
            pending
            content role
            unclassified_context
            context span
            end
            594
            end exclusive
            true
            exact text
            patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. ( 1 )
            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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            current approval status
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            duplicate text group
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            extraction review status
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            generic names
            1. DACOMITINIB
            id
            ind-span-032747c4f0b6c44f7c77
            label id
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            positive predicate support span
            Source null
            qualifier mentions
              regulatory links
                schema version
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                source batch sha256
                d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571
                source defined aliases
                1. abbreviation
                  NSCLC
                  definition exact
                  non-small cell lung cancer
                  definition span
                  end
                  137
                  end exclusive
                  true
                  exact text
                  non-small cell lung cancer (NSCLC)
                  label id
                  3ffd0da1-5601-4ecc-a8fb-f484693cb4c5
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  33bb621eb63a57753109465b5698af7066605be3d03218d1f1f3f118ca209f86
                  start
                  103
                source span
                end
                594
                end exclusive
                true
                exact text
                ( 1 )
                label id
                3ffd0da1-5601-4ecc-a8fb-f484693cb4c5
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                33bb621eb63a57753109465b5698af7066605be3d03218d1f1f3f118ca209f86
                start
                589
                source url
                https://api.fda.gov/drug/label.json?search=id%3A%223ffd0da1-5601-4ecc-a8fb-f484693cb4c5%22
                spl effective date
                2026-06-23
                spl set id
                4ab27d2f-e385-4e9c-b324-fa69c10b855a
                spl version
                9
                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