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STATUS · fda-aa-c23b04eb67672e5e0497

Tepmetko (tepotinib)

Open original source → · Download preserved record

This status concerns only the indication wording below. It must not be applied to other uses of the same drug. It is not reconciled against the current label.

Exact indication

Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.

Source status category
verified clinical benefit
Event date
2024-02-15
Meaning of this date
FDA table traditional approval date
accelerated approval date
2021-02-03
accelerated approval date source text
2/3/2021
brand name hint
Tepmetko
date change comparison status
no_previous_normalized_snapshot_supplied
date change from prior snapshot
Source null
drug name exact
Tepmetko (tepotinib)
generic name hint
tepotinib
id
fda-aa-c23b04eb67672e5e0497
indication exact
Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
original projected completion source text
Source null
post marketing requirement exact
Source null
record type
fda_accelerated_approval_status_row
related fda urls
    source cells exact
    1. links
        text
        Tepmetko (tepotinib)
      1. links
          text
          Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
        1. links
            text
            2/3/2021
          1. links
              text
              2/15/2024
            source provenance
            bytes
            74315
            file
            /private/tmp/cancer-full-research/indications/raw/accelerated-verified.html
            http status
            200
            retrieved at
            2026-09-09T23:35:16.058704+00:00
            sha256
            91f921503728c2afb0ec500d9c6034553e0b81d5af260a20c5478686c1127a7e
            source page date Modified text
            Wed, 07/15/2026 - 00:00
            source page date Published text
            Wed, 07/15/2026 - 07:11
            source row index
            25
            source table headers
            1. Drug Name
            2. Accelerated Approval (AA) Indication
            3. Accelerated Approval Date
            4. Traditional Approval Date
            source table index
            0
            source url
            https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
            status applies to
            This exact indication and regimen, not every use of this drug
            status category
            verified_clinical_benefit
            status event date
            2024-02-15
            status event date meaning
            FDA table traditional approval date
            traditional approval date
            2024-02-15
            verification flags
              verification status
              official_fda_status_table_extracted_indication_matching_not_clinically_reviewed
              withdrawal date
              Source null
              Source correspondence records
              matching
              drug name exact
              Tepmetko (tepotinib)
              fda status record id
              fda-aa-c23b04eb67672e5e0497
              indication exact
              Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
              match status
              source_correspondence_found_clinical_review_pending
              matched candidate ids
              1. ind-span-a7ebffbf288034884a90
              2. ind-span-c1bdc8fedb33dfd6856b
              source provenance
              bytes
              74315
              file
              /private/tmp/cancer-full-research/indications/raw/accelerated-verified.html
              http status
              200
              retrieved at
              2026-09-09T23:35:16.058704+00:00
              sha256
              91f921503728c2afb0ec500d9c6034553e0b81d5af260a20c5478686c1127a7e
              source page date Modified text
              Wed, 07/15/2026 - 00:00
              source page date Published text
              Wed, 07/15/2026 - 07:11
              status category
              verified_clinical_benefit
              unmatched meaning
              Source null
              links
              1. package id
                fda-label-library-8184721b7b3bb86692f8276c
                correspondence id
                correspondence-a9f13d80da38100f2245a982
                span id
                ind-span-a7ebffbf288034884a90
                status id
                fda-aa-c23b04eb67672e5e0497
                match method
                whole_indication_literal_normalized_substring
                scope relationship
                whole_fda_indication_text_present
                matching review status
                source_comparison_only_clinical_review_pending
                payload
                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
                source array index
                0
                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
                1. package id
                  fda-label-library-8184721b7b3bb86692f8276c
                  correspondence id
                  correspondence-b87a5c7aa5ec3098935cd564
                  span id
                  ind-span-c1bdc8fedb33dfd6856b
                  status id
                  fda-aa-c23b04eb67672e5e0497
                  match method
                  whole_indication_literal_normalized_substring
                  scope relationship
                  whole_fda_indication_text_present
                  matching review status
                  source_comparison_only_clinical_review_pending
                  payload
                  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.
                  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
                  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
                  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

                  Preserved source evidence · Not medical advice