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LABELS · 6da26ba2-92a2-4c0f-b733-946f25c71338

KIMMTRAK

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
2026-08-20
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. BOXED WARNING: CYTOKINE RELEASE SYNDROME Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated [(see Dosage and Administration (2.2) , see Warnings and Precautions (5.1) ] . WARNING: CYTOKINE RELEASE SYNDROME Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated ( 2.2 , 5.1 ).

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE KIMMTRAK is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. KIMMTRAK is a bispecific gp100 peptide-HLA-directed CD3 T cell engager indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma ( 1 , 2.1 ).
Full extracted label fields
application numbers
  1. BLA761228
boxed warning exact
  1. BOXED WARNING: CYTOKINE RELEASE SYNDROME Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated [(see Dosage and Administration (2.2) , see Warnings and Precautions (5.1) ] . WARNING: CYTOKINE RELEASE SYNDROME Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated ( 2.2 , 5.1 ).
brand names
  1. KIMMTRAK
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=24a49f57-d2fc-4ffe-9eb1-fe0460c6b067
generic names
  1. TEBENTAFUSP
id
6da26ba2-92a2-4c0f-b733-946f25c71338
indications and usage exact
  1. 1 INDICATIONS AND USAGE KIMMTRAK is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. KIMMTRAK is a bispecific gp100 peptide-HLA-directed CD3 T cell engager indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma ( 1 , 2.1 ).
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Immunocore Commercial LLC
    matched search terms
    1. melanoma
    package ndcs
    1. 80446-401-01
    product ndcs
    1. 80446-401
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      rxcuis
      1. 2590748
      2. 2590754
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00400.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
      400
      total
      830
      sha256
      a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
      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=400&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%226da26ba2-92a2-4c0f-b733-946f25c71338%22
      spl effective date
      2026-08-20
      spl effective time
      20260820
      spl set id
      24a49f57-d2fc-4ffe-9eb1-fe0460c6b067
      spl version
      9
      substance names
      1. TEBENTAFUSP
      uniis
      1. N658GY6L3E
      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
        BLA761228
        payload
        all indexed label documents
        1. Appl No
          761228
          Application Docs Date
          2022-01-26 00:00:00
          Application Docs ID
          69977
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          761228
          Application Docs Date
          2022-12-01 00:00:00
          Application Docs ID
          72762
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        3. Appl No
          761228
          Application Docs Date
          2024-06-28 00:00:00
          Application Docs ID
          78930
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          761228
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2022-01-25 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          761228
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2022-11-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          761228
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2024-06-27 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        BLA761228
        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
        2024-06-27
        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
          761228
          Application Docs Date
          2024-06-28 00:00:00
          Application Docs ID
          78930
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        official application record
        Appl No
        761228
        Appl Public Notes
        Appl Type
        BLA
        Sponsor Name
        IMMUNOCORE LTD
        openfda application present
        true
        products
        1. Active Ingredient
          TEBENTAFUSP-TEBN
          Appl No
          761228
          Drug Name
          KIMMTRAK
          Form
          INJECTABLE;INJECTION
          Product No
          001
          Reference Drug
          0
          Reference Standard
          0
          Strength
          100MCG/0.5ML
          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. BLA761228
      brand names
      1. KIMMTRAK
      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
      348
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE KIMMTRAK is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. KIMMTRAK is a bispecific gp100 peptide-HLA-directed CD3 T cell engager indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma ( 1 , 2.1 ).
      label id
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      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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      current approval status
      not_reconciled
      duplicate text group
      dup-5fdbfed39c342723a748
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. TEBENTAFUSP
      id
      ind-span-cb012490ac45bf75aaf7
      label id
      6da26ba2-92a2-4c0f-b733-946f25c71338
      positive predicate support span
      end
      45
      end exclusive
      true
      exact text
      is indicated
      label id
      6da26ba2-92a2-4c0f-b733-946f25c71338
      offset unit
      unicode_code_points
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      source field
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      source text sha256
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      qualifier mentions
      1. context exact
        TRAK is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
        kind
        age
        polarity
        not_inferred
        span
        end
        102
        end exclusive
        true
        exact text
        adult patients
        label id
        6da26ba2-92a2-4c0f-b733-946f25c71338
        offset unit
        unicode_code_points
        source array index
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        source text sha256
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      2. context exact
        of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        149
        end exclusive
        true
        exact text
        metastatic uveal melanoma
        label id
        6da26ba2-92a2-4c0f-b733-946f25c71338
        offset unit
        unicode_code_points
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        0
        source field
        indications_and_usage_exact
        source text sha256
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      3. context exact
        r the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
        kind
        stage_or_setting
        polarity
        not_inferred
        span
        end
        149
        end exclusive
        true
        exact text
        unresectable or metastatic uveal melanoma
        label id
        6da26ba2-92a2-4c0f-b733-946f25c71338
        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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      regulatory links
        schema version
        0.1.0
        source batch sha256
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        source defined aliases
          source span
          end
          150
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE KIMMTRAK is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
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          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%226da26ba2-92a2-4c0f-b733-946f25c71338%22
          spl effective date
          2026-08-20
          spl set id
          24a49f57-d2fc-4ffe-9eb1-fe0460c6b067
          spl version
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          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. BLA761228
          brand names
          1. KIMMTRAK
          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
          348
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE KIMMTRAK is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. KIMMTRAK is a bispecific gp100 peptide-HLA-directed CD3 T cell engager indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma ( 1 , 2.1 ).
          label id
          6da26ba2-92a2-4c0f-b733-946f25c71338
          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
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          extraction review status
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          generic names
          1. TEBENTAFUSP
          id
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          label id
          6da26ba2-92a2-4c0f-b733-946f25c71338
          positive predicate support span
          end
          231
          end exclusive
          true
          exact text
          is a bispecific gp100 peptide-HLA-directed CD3 T cell engager indicated
          label id
          6da26ba2-92a2-4c0f-b733-946f25c71338
          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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          start
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          qualifier mentions
          1. context exact
            engager indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma ( 1 , 2.1 ).
            kind
            age
            polarity
            not_inferred
            span
            end
            288
            end exclusive
            true
            exact text
            adult patients
            label id
            6da26ba2-92a2-4c0f-b733-946f25c71338
            offset unit
            unicode_code_points
            source array index
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            source field
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          2. context exact
            of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma ( 1 , 2.1 ).
            kind
            biomarker
            polarity
            not_inferred
            span
            end
            340
            end exclusive
            true
            exact text
            metastatic uveal melanoma ( 1
            label id
            6da26ba2-92a2-4c0f-b733-946f25c71338
            offset unit
            unicode_code_points
            source array index
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            source field
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          3. context exact
            r the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma ( 1 , 2.1 ).
            kind
            stage_or_setting
            polarity
            not_inferred
            span
            end
            340
            end exclusive
            true
            exact text
            unresectable or metastatic uveal melanoma ( 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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          regulatory links
            schema version
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            source batch sha256
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            source defined aliases
              source span
              end
              348
              end exclusive
              true
              exact text
              KIMMTRAK is a bispecific gp100 peptide-HLA-directed CD3 T cell engager indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma ( 1 , 2.1 ).
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              6da26ba2-92a2-4c0f-b733-946f25c71338
              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 url
              https://api.fda.gov/drug/label.json?search=id%3A%226da26ba2-92a2-4c0f-b733-946f25c71338%22
              spl effective date
              2026-08-20
              spl set id
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              spl version
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              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

              Preserved source evidence · Not medical advice