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LABELS · d922de79-b0f0-4ed2-b551-c7a86ed72d7d

TEPMETKO

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
2025-04-17
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 TEPMETKO is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14 skipping alterations. TEPMETKO is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14 skipping alterations. ( 1 )
Full extracted label fields
application numbers
  1. NDA214096
boxed warning exact
    brand names
    1. TEPMETKO
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=80a0f1b9-071a-47f5-9e67-32d638a669dc
    generic names
    1. TEPOTINIB HYDROCHLORIDE
    id
    d922de79-b0f0-4ed2-b551-c7a86ed72d7d
    indications and usage exact
    1. 1 INDICATIONS AND USAGE TEPMETKO is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14 skipping alterations. TEPMETKO is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14 skipping alterations. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. EMD Serono, Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 44087-5000-3
      2. 44087-5000-6
      product ndcs
      1. 44087-5000
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Indication and Usage ( 1 ) 02/2024 Dosage and Administration ( 2.3 , 2.4 ) 02/2024 Warnings and Precautions ( 5.3 ) 02/2024
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 2477266
      2. 2477272
      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%22d922de79-b0f0-4ed2-b551-c7a86ed72d7d%22
      spl effective date
      2025-04-17
      spl effective time
      20250417
      spl set id
      80a0f1b9-071a-47f5-9e67-32d638a669dc
      spl version
      8
      substance names
      1. TEPOTINIB HYDROCHLORIDE
      uniis
      1. VY5YX2TQ1F
      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
        NDA214096
        payload
        all indexed label documents
        1. Appl No
          214096
          Application Docs Date
          2021-02-03 00:00:00
          Application Docs ID
          66080
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          214096
          Application Docs Date
          2023-03-24 00:00:00
          Application Docs ID
          73861
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        3. Appl No
          214096
          Application Docs Date
          2023-03-24 00:00:00
          Application Docs ID
          73862
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        4. Appl No
          214096
          Application Docs Date
          2024-02-16 00:00:00
          Application Docs ID
          77508
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          214096
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2021-02-03 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          214096
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2023-03-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          214096
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2023-03-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          214096
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2024-02-15 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA214096
        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
        2024-02-15
        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
          214096
          Application Docs Date
          2024-02-16 00:00:00
          Application Docs ID
          77508
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        official application record
        Appl No
        214096
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        EMD SERONO INC
        openfda application present
        true
        products
        1. Active Ingredient
          TEPOTINIB HYDROCHLORIDE
          Appl No
          214096
          Drug Name
          TEPMETKO
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 225MG 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. NDA214096
      brand names
      1. TEPMETKO
      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
      414
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE TEPMETKO is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14 skipping alterations. TEPMETKO is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14 skipping al
      label id
      d922de79-b0f0-4ed2-b551-c7a86ed72d7d
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      4133e51ff1443ab642c2e19e86d400a3fa86d6496a9ece9839e425f38fd7c887
      start
      0
      current approval status
      not_reconciled
      duplicate text group
      dup-4e2def5264d51506518b
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. TEPOTINIB HYDROCHLORIDE
      id
      ind-span-a7ebffbf288034884a90
      label id
      d922de79-b0f0-4ed2-b551-c7a86ed72d7d
      positive predicate support span
      end
      45
      end exclusive
      true
      exact text
      is indicated
      label id
      d922de79-b0f0-4ed2-b551-c7a86ed72d7d
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      4133e51ff1443ab642c2e19e86d400a3fa86d6496a9ece9839e425f38fd7c887
      start
      33
      qualifier mentions
      1. context exact
        ATIONS AND USAGE TEPMETKO is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harborin
        kind
        age
        polarity
        not_inferred
        span
        end
        81
        end exclusive
        true
        exact text
        adult patients
        label id
        d922de79-b0f0-4ed2-b551-c7a86ed72d7d
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        4133e51ff1443ab642c2e19e86d400a3fa86d6496a9ece9839e425f38fd7c887
        start
        67
      2. context exact
        METKO is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        130
        end exclusive
        true
        exact text
        metastatic non-small cell lung cancer (NSCL
        label id
        d922de79-b0f0-4ed2-b551-c7a86ed72d7d
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        4133e51ff1443ab642c2e19e86d400a3fa86d6496a9ece9839e425f38fd7c887
        start
        87
      3. context exact
        ancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14 skipping alterations.
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        213
        end exclusive
        true
        exact text
        MET ) exon 14 skipping alterations
        label id
        d922de79-b0f0-4ed2-b551-c7a86ed72d7d
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        4133e51ff1443ab642c2e19e86d400a3fa86d6496a9ece9839e425f38fd7c887
        start
        179
      4. context exact
        METKO is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14
        kind
        stage_or_setting
        polarity
        not_inferred
        span
        end
        132
        end exclusive
        true
        exact text
        metastatic non-small cell lung cancer (NSCLC)
        label id
        d922de79-b0f0-4ed2-b551-c7a86ed72d7d
        offset unit
        unicode_code_points
        source array index
        0
        source field
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        source text sha256
        4133e51ff1443ab642c2e19e86d400a3fa86d6496a9ece9839e425f38fd7c887
        start
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      regulatory links
      1. candidate source span
        end
        214
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE TEPMETKO is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14 skipping alterations.
        label id
        d922de79-b0f0-4ed2-b551-c7a86ed72d7d
        offset unit
        unicode_code_points
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        source field
        indications_and_usage_exact
        source text sha256
        4133e51ff1443ab642c2e19e86d400a3fa86d6496a9ece9839e425f38fd7c887
        start
        0
        fda indication exact
        Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
        fda source row index
        25
        fda source sha256
        91f921503728c2afb0ec500d9c6034553e0b81d5af260a20c5478686c1127a7e
        fda status record id
        fda-aa-c23b04eb67672e5e0497
        interpretation
        Source wording correspondence to a dated FDA status row; current approval not certified
        match method
        whole_indication_literal_normalized_substring
        matching review status
        source_comparison_only_clinical_review_pending
        scope relationship
        whole_fda_indication_text_present
        status category
        verified_clinical_benefit
        status event date
        2024-02-15
        supporting anchor spans
        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
          132
          end exclusive
          true
          exact text
          non-small cell lung cancer (NSCLC)
          label id
          d922de79-b0f0-4ed2-b551-c7a86ed72d7d
          offset unit
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          source field
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          source text sha256
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          start
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        source span
        end
        214
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE TEPMETKO is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14 skipping alterations.
        label id
        d922de79-b0f0-4ed2-b551-c7a86ed72d7d
        offset unit
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        source field
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        source text sha256
        4133e51ff1443ab642c2e19e86d400a3fa86d6496a9ece9839e425f38fd7c887
        start
        0
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22d922de79-b0f0-4ed2-b551-c7a86ed72d7d%22
        spl effective date
        2025-04-17
        spl set id
        80a0f1b9-071a-47f5-9e67-32d638a669dc
        spl version
        8
        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

        Read indication-specific status → · whole_fda_indication_text_present

        Passage 2 · positive indication candidate
        application numbers
        1. NDA214096
        brand names
        1. TEPMETKO
        classification reasons
        1. explicit_positive_indication_predicate
        2. tumor_or_malignant_hematology_words_in_positive_statement
        clinical review status
        pending
        content role
        positive_indication_candidate
        context span
        end
        430
        end exclusive
        true
        exact text
        ND USAGE TEPMETKO is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14 skipping alterations. TEPMETKO is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14 skipping alterations. ( 1 )
        label id
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        offset unit
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        source text sha256
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        start
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        current approval status
        not_reconciled
        duplicate text group
        dup-18231aba1816ee0b2db6
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. TEPOTINIB HYDROCHLORIDE
        id
        ind-span-c1bdc8fedb33dfd6856b
        label id
        d922de79-b0f0-4ed2-b551-c7a86ed72d7d
        positive predicate support span
        end
        255
        end exclusive
        true
        exact text
        is a kinase inhibitor indicated
        label id
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        offset unit
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        source text sha256
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        start
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        qualifier mentions
        1. context exact
          PMETKO is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harborin
          kind
          age
          polarity
          not_inferred
          span
          end
          291
          end exclusive
          true
          exact text
          adult patients
          label id
          d922de79-b0f0-4ed2-b551-c7a86ed72d7d
          offset unit
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          source text sha256
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          start
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        2. context exact
          nhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          340
          end exclusive
          true
          exact text
          metastatic non-small cell lung cancer (NSCL
          label id
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          offset unit
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          source text sha256
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        3. context exact
          ancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14 skipping alterations.
          kind
          biomarker
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          span
          end
          423
          end exclusive
          true
          exact text
          MET ) exon 14 skipping alterations
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          offset unit
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        4. context exact
          nhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14
          kind
          stage_or_setting
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          not_inferred
          span
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          342
          end exclusive
          true
          exact text
          metastatic non-small cell lung cancer (NSCLC)
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        regulatory links
        1. candidate source span
          end
          424
          end exclusive
          true
          exact text
          TEPMETKO is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14 skipping alterations.
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          source text sha256
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          start
          215
          fda indication exact
          Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
          fda source row index
          25
          fda source sha256
          91f921503728c2afb0ec500d9c6034553e0b81d5af260a20c5478686c1127a7e
          fda status record id
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          interpretation
          Source wording correspondence to a dated FDA status row; current approval not certified
          match method
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          matching review status
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          scope relationship
          whole_fda_indication_text_present
          status category
          verified_clinical_benefit
          status event date
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          supporting anchor spans
          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
            132
            end exclusive
            true
            exact text
            non-small cell lung cancer (NSCLC)
            label id
            d922de79-b0f0-4ed2-b551-c7a86ed72d7d
            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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          source span
          end
          424
          end exclusive
          true
          exact text
          TEPMETKO is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14 skipping alterations.
          label id
          d922de79-b0f0-4ed2-b551-c7a86ed72d7d
          offset unit
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          source field
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          source text sha256
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          source url
          https://api.fda.gov/drug/label.json?search=id%3A%22d922de79-b0f0-4ed2-b551-c7a86ed72d7d%22
          spl effective date
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          spl set id
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          spl version
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          structured fields status
          not_extracted_no_values_inferred_from_mentions
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          age
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          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

          Read indication-specific status → · whole_fda_indication_text_present

          Passage 3 · unclassified context
          application numbers
          1. NDA214096
          brand names
          1. TEPMETKO
          classification reasons
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          clinical review status
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          exact text
          s a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET ) exon 14 skipping alterations. ( 1 )
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          d922de79-b0f0-4ed2-b551-c7a86ed72d7d
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          source array index
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          source field
          indications_and_usage_exact
          source text sha256
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          225
          current approval status
          not_reconciled
          duplicate text group
          dup-819be3e4c7ebaac68f73
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. TEPOTINIB HYDROCHLORIDE
          id
          ind-span-8bb73d8459c1e56d8b92
          label id
          d922de79-b0f0-4ed2-b551-c7a86ed72d7d
          positive predicate support span
          Source null
          qualifier mentions
            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
                132
                end exclusive
                true
                exact text
                non-small cell lung cancer (NSCLC)
                label id
                d922de79-b0f0-4ed2-b551-c7a86ed72d7d
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                4133e51ff1443ab642c2e19e86d400a3fa86d6496a9ece9839e425f38fd7c887
                start
                98
              source span
              end
              430
              end exclusive
              true
              exact text
              ( 1 )
              label id
              d922de79-b0f0-4ed2-b551-c7a86ed72d7d
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              4133e51ff1443ab642c2e19e86d400a3fa86d6496a9ece9839e425f38fd7c887
              start
              425
              source url
              https://api.fda.gov/drug/label.json?search=id%3A%22d922de79-b0f0-4ed2-b551-c7a86ed72d7d%22
              spl effective date
              2025-04-17
              spl set id
              80a0f1b9-071a-47f5-9e67-32d638a669dc
              spl version
              8
              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