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LABELS · 8c405b95-6d3c-4bc5-9b01-2feb80903756

ZYKADIA

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

Label effective date
2025-12-15
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE ZYKADIA ® 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 [see Dosage and Administration (2.1)] . ZYKADIA is a kinase inhibitor indicated for the treatment of adults 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. NDA211225
boxed warning exact
    brand names
    1. ZYKADIA
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fff5d805-4ffd-4e8e-8e63-6f129697563e
    generic names
    1. CERITINIB
    id
    8c405b95-6d3c-4bc5-9b01-2feb80903756
    indications and usage exact
    1. 1 INDICATIONS AND USAGE ZYKADIA ® 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 [see Dosage and Administration (2.1)] . ZYKADIA is a kinase inhibitor indicated for the treatment of adults 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. Novartis Pharmaceuticals Corporation
      matched search terms
      1. cancer
      2. lymphoma
      3. tumors
      package ndcs
      1. 0078-0694-84
      2. 0078-0694-48
      product ndcs
      1. 0078-0694
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions, Gastrointestinal Adverse Reactions ( 5.1 ) 8/2021
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 2121059
      2. 2121061
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00500.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
      500
      total
      830
      sha256
      424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
      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=500&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%228c405b95-6d3c-4bc5-9b01-2feb80903756%22
      spl effective date
      2025-12-15
      spl effective time
      20251215
      spl set id
      fff5d805-4ffd-4e8e-8e63-6f129697563e
      spl version
      21
      substance names
      1. CERITINIB
      uniis
      1. K418KG2GET
      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
        NDA211225
        payload
        all indexed label documents
        1. Appl No
          211225
          Application Docs Date
          2019-03-19 00:00:00
          Application Docs ID
          58033
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          211225
          Application Docs Date
          2021-08-22 00:00:00
          Application Docs ID
          68431
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        3. Appl No
          211225
          Application Docs Date
          2021-10-13 00:00:00
          Application Docs ID
          68977
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          211225
          Review Priority
          STANDARD
          Submission Class Code ID
          19
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2019-03-18 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          211225
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2021-08-19 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          211225
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          2021-10-07 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA211225
        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
        2021-10-07
        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
          211225
          Application Docs Date
          2021-10-13 00:00:00
          Application Docs ID
          68977
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        official application record
        Appl No
        211225
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        NOVARTIS
        openfda application present
        true
        products
        1. Active Ingredient
          CERITINIB
          Appl No
          211225
          Drug Name
          ZYKADIA
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          150MG
          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. NDA211225
      brand names
      1. ZYKADIA
      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
      468
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE ZYKADIA ® 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 [see Dosage and Administration (2.1)] . ZYKADIA is a kinase inhibitor indicated for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA
      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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      current approval status
      not_reconciled
      duplicate text group
      dup-15255fe064af0bafdf61
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. CERITINIB
      id
      ind-span-6811021fe56cdd648c15
      label id
      8c405b95-6d3c-4bc5-9b01-2feb80903756
      positive predicate support span
      end
      46
      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
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      source text sha256
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      qualifier mentions
      1. context exact
        TIONS AND USAGE ZYKADIA ® 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
        82
        end exclusive
        true
        exact text
        adult patients
        label id
        8c405b95-6d3c-4bc5-9b01-2feb80903756
        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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      2. context exact
        DIA ® 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
        131
        end exclusive
        true
        exact text
        metastatic non-small cell lung cancer (NSCL
        label id
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        offset unit
        unicode_code_points
        source array index
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        indications_and_usage_exact
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      3. context exact
        cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test [see Dosage and Administration (2.1)] .
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        222
        end exclusive
        true
        exact text
        ALK)-positive as detected by an FDA-approve
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      4. context exact
        DIA ® 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
        133
        end exclusive
        true
        exact text
        metastatic non-small cell lung cancer (NSCLC)
        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
        424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
        source defined aliases
        1. abbreviation
          NSCLC
          definition exact
          non-small cell lung cancer
          definition span
          end
          133
          end exclusive
          true
          exact text
          non-small cell lung cancer (NSCLC)
          label id
          8c405b95-6d3c-4bc5-9b01-2feb80903756
          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
        end
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        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE ZYKADIA ® 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 [see Dosage and Administration (2.1)] .
        label id
        8c405b95-6d3c-4bc5-9b01-2feb80903756
        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%228c405b95-6d3c-4bc5-9b01-2feb80903756%22
        spl effective date
        2025-12-15
        spl set id
        fff5d805-4ffd-4e8e-8e63-6f129697563e
        spl version
        21
        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. NDA211225
        brand names
        1. ZYKADIA
        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
        495
        end exclusive
        true
        exact text
        dult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test [see Dosage and Administration (2.1)] . ZYKADIA is a kinase inhibitor indicated for the treatment of adults 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
        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-912b802f16edc0f651a5
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. CERITINIB
        id
        ind-span-1b3d9225543d6bde1c1c
        label id
        8c405b95-6d3c-4bc5-9b01-2feb80903756
        positive predicate support span
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        308
        end exclusive
        true
        exact text
        is a kinase inhibitor indicated
        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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        qualifier mentions
        1. context exact
          YKADIA is a kinase inhibitor indicated for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tu
          kind
          age
          polarity
          not_inferred
          span
          end
          336
          end exclusive
          true
          exact text
          adults
          label id
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          offset unit
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        2. context exact
          kinase inhibitor indicated for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positiv
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          385
          end exclusive
          true
          exact text
          metastatic non-small cell lung cancer (NSCL
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        3. context exact
          cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
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        4. context exact
          kinase inhibitor indicated for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive
          kind
          stage_or_setting
          polarity
          not_inferred
          span
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          end exclusive
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          exact text
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        regulatory links
          schema version
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          source batch sha256
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          source defined aliases
          1. abbreviation
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            definition exact
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            end
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            end exclusive
            true
            exact text
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          source span
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          end exclusive
          true
          exact text
          ZYKADIA is a kinase inhibitor indicated for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
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          source url
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          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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          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. NDA211225
          brand names
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          classification reasons
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          clinical review status
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          content role
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          context span
          end
          495
          end exclusive
          true
          exact text
          nase inhibitor indicated for the treatment of adults 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
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          duplicate text group
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          extraction review status
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          generic names
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          id
          ind-span-774224c3f551126e3e71
          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
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              source defined aliases
              1. abbreviation
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                definition exact
                non-small cell lung cancer
                definition span
                end
                133
                end exclusive
                true
                exact text
                non-small cell lung cancer (NSCLC)
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                offset unit
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                start
                99
              source span
              end
              495
              end exclusive
              true
              exact text
              ( 1 , 2.1 )
              label id
              8c405b95-6d3c-4bc5-9b01-2feb80903756
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              00cf5f9371853323fb1f769a31ffb3a2e2bb8054ac77754975bd6cd1fde2f855
              start
              484
              source url
              https://api.fda.gov/drug/label.json?search=id%3A%228c405b95-6d3c-4bc5-9b01-2feb80903756%22
              spl effective date
              2025-12-15
              spl set id
              fff5d805-4ffd-4e8e-8e63-6f129697563e
              spl version
              21
              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