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LABELS · 8a0ceb7f-ea10-4b90-97fb-530d5f2a0bd2

LOQTORZI

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
2026-07-23
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 LOQTORZI is a programmed death receptor-1 (PD-1)- blocking antibody indicated: in combination with cisplatin and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma (NPC) ( 1.1 ) as a single agent for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy ( 1.2 ) 1.1 First-line Treatment of Metastatic or Recurrent, Locally Advanced NPC with Cisplatin and Gemcitabine LOQTORZI is indicated, in combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or with recurrent, locally advanced nasopharyngeal carcinoma (NPC). 1.2 Previously Treated Unresectable or Metastatic NPC LOQTORZI is indicated, as a single agent, for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy.
Full extracted label fields
application numbers
  1. BLA761240
boxed warning exact
    brand names
    1. LOQTORZI
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=82e7921a-1e84-4988-9799-0ad7d19b2a75
    generic names
    1. TORIPALIMAB-TPZI
    id
    8a0ceb7f-ea10-4b90-97fb-530d5f2a0bd2
    indications and usage exact
    1. 1 INDICATIONS AND USAGE LOQTORZI is a programmed death receptor-1 (PD-1)- blocking antibody indicated: in combination with cisplatin and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma (NPC) ( 1.1 ) as a single agent for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy ( 1.2 ) 1.1 First-line Treatment of Metastatic or Recurrent, Locally Advanced NPC with Cisplatin and Gemcitabine LOQTORZI is indicated, in combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or with recurrent, locally advanced nasopharyngeal carcinoma (NPC). 1.2 Previously Treated Unresectable or Metastatic NPC LOQTORZI is indicated, as a single agent, for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Coherus Oncology, Inc.
      matched search terms
      1. carcinoma
      package ndcs
      1. 70114-340-01
      product ndcs
      1. 70114-340
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions ( 5.1 ) 04/2024 Dosage and Administration ( 2 ) 10/2024 Warnings and Precautions ( 5.1 ) 07/2026
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      rxcuis
      1. 2669413
      2. 2669420
      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%228a0ceb7f-ea10-4b90-97fb-530d5f2a0bd2%22
      spl effective date
      2026-07-23
      spl effective time
      20260723
      spl set id
      82e7921a-1e84-4988-9799-0ad7d19b2a75
      spl version
      9
      substance names
      1. TORIPALIMAB
      uniis
      1. 8JXN261VVA
      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
      4. fda_label_posted_after_spl_effective_date_requires_version_review
      Drugs@FDA application source records
      1. application number
        BLA761240
        payload
        all indexed label documents
        1. Appl No
          761240
          Application Docs Date
          2023-10-30 00:00:00
          Application Docs ID
          75981
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          761240
          Application Docs Date
          2024-04-25 00:00:00
          Application Docs ID
          78251
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        3. Appl No
          761240
          Application Docs Date
          2024-11-01 00:00:00
          Application Docs ID
          80063
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        4. Appl No
          761240
          Application Docs Date
          2026-09-01 00:00:00
          Application Docs ID
          87111
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          761240
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2023-10-27 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          761240
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2024-04-22 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          761240
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2024-10-30 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          761240
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2026-08-31 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        BLA761240
        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
        2026-08-31
        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
          761240
          Application Docs Date
          2026-09-01 00:00:00
          Application Docs ID
          87111
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        official application record
        Appl No
        761240
        Appl Public Notes
        Appl Type
        BLA
        Sponsor Name
        COHERUS BIOSCIENCES INC
        openfda application present
        true
        products
        1. Active Ingredient
          TORIPALIMAB-TPZI
          Appl No
          761240
          Drug Name
          LOQTORZI
          Form
          INJECTABLE;INJECTION
          Product No
          001
          Reference Drug
          0
          Reference Standard
          0
          Strength
          240MG/6ML(40MG/ML)
          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. BLA761240
      brand names
      1. LOQTORZI
      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
      474
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE LOQTORZI is a programmed death receptor-1 (PD-1)- blocking antibody indicated: in combination with cisplatin and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma (NPC) ( 1.1 ) as a single agent for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy ( 1.2 ) 1.1 First-line Treatment of
      label id
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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-43b3852b2781a673363c
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. TORIPALIMAB-TPZI
      id
      ind-span-de3662b92c684eebba5d
      label id
      8a0ceb7f-ea10-4b90-97fb-530d5f2a0bd2
      positive predicate support span
      end
      101
      end exclusive
      true
      exact text
      is a programmed death receptor-1 (PD-1)- blocking antibody indicated
      label id
      8a0ceb7f-ea10-4b90-97fb-530d5f2a0bd2
      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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      start
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      qualifier mentions
      1. context exact
        with cisplatin and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced nasophar
        kind
        age
        polarity
        not_inferred
        span
        end
        184
        end exclusive
        true
        exact text
        adults
        label id
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        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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      2. context exact
        in and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma (NPC) ( 1.1 )
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        233
        end exclusive
        true
        exact text
        metastatic or with recurrent locally advanc
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        8a0ceb7f-ea10-4b90-97fb-530d5f2a0bd2
        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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      3. context exact
        in and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma (NPC) ( 1.1 )
        kind
        stage_or_setting
        polarity
        not_inferred
        span
        end
        235
        end exclusive
        true
        exact text
        metastatic or with recurrent locally advanced
        label id
        8a0ceb7f-ea10-4b90-97fb-530d5f2a0bd2
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        68e08cfaffa2c51e153ae8935905e8bb8b3b13b5f2afd7e62102b1e7f294e8df
        start
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      4. context exact
        dicated: in combination with cisplatin and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma (NPC) ( 1.1 )
        kind
        prior_therapy_or_line
        polarity
        not_inferred
        span
        end
        270
        end exclusive
        true
        exact text
        first-line treatment of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma (NPC) ( 1
        label id
        8a0ceb7f-ea10-4b90-97fb-530d5f2a0bd2
        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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        start
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      5. context exact
        ammed death receptor-1 (PD-1)- blocking antibody indicated: in combination with cisplatin and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma (NPC) ( 1.1 )
        kind
        regimen
        polarity
        not_inferred
        span
        end
        270
        end exclusive
        true
        exact text
        in combination with cisplatin and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma (NPC) ( 1
        label id
        8a0ceb7f-ea10-4b90-97fb-530d5f2a0bd2
        offset unit
        unicode_code_points
        source array index
        0
        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
          274
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE LOQTORZI is a programmed death receptor-1 (PD-1)- blocking antibody indicated: in combination with cisplatin and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma (NPC) ( 1.1 )
          label id
          8a0ceb7f-ea10-4b90-97fb-530d5f2a0bd2
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          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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          source url
          https://api.fda.gov/drug/label.json?search=id%3A%228a0ceb7f-ea10-4b90-97fb-530d5f2a0bd2%22
          spl effective date
          2026-07-23
          spl set id
          82e7921a-1e84-4988-9799-0ad7d19b2a75
          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. BLA761240
          brand names
          1. LOQTORZI
          classification reasons
          1. inherited_predicate_from_same_label_section_requires_review
          2. no_tumor_directed_keyword_in_positive_statement
          clinical review status
          pending
          content role
          positive_indication_candidate
          context span
          end
          646
          end exclusive
          true
          exact text
          locking antibody indicated: in combination with cisplatin and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma (NPC) ( 1.1 ) as a single agent for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy ( 1.2 ) 1.1 First-line Treatment of Metastatic or Recurrent, Locally Advanced NPC with Cisplatin and Gemcitabine LOQTORZI is indicated, in combination with cisplatin and gemcitabine, for the first-line treat
          label id
          8a0ceb7f-ea10-4b90-97fb-530d5f2a0bd2
          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-3a0f76880888b1675a9d
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. TORIPALIMAB-TPZI
          id
          ind-span-b69f6727d91c53f05ca3
          label id
          8a0ceb7f-ea10-4b90-97fb-530d5f2a0bd2
          positive predicate support span
          end
          101
          end exclusive
          true
          exact text
          is a programmed death receptor-1 (PD-1)- blocking antibody indicated
          label id
          8a0ceb7f-ea10-4b90-97fb-530d5f2a0bd2
          offset unit
          unicode_code_points
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          source field
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          start
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          qualifier mentions
          1. context exact
            as a single agent for the treatment of adults with recurrent unresectable or metastatic NPC with disease
            kind
            age
            polarity
            not_inferred
            span
            end
            320
            end exclusive
            true
            exact text
            adults
            label id
            8a0ceb7f-ea10-4b90-97fb-530d5f2a0bd2
            offset unit
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            source array index
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          2. context exact
            for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy ( 1.2 )
            kind
            biomarker
            polarity
            not_inferred
            span
            end
            395
            end exclusive
            true
            exact text
            metastatic NPC with disease progression on
            label id
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            offset unit
            unicode_code_points
            source array index
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            source field
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          3. context exact
            as a single agent for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chem
            kind
            stage_or_setting
            polarity
            not_inferred
            span
            end
            370
            end exclusive
            true
            exact text
            recurrent unresectable or metastatic NPC wit
            label id
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            offset unit
            unicode_code_points
            source array index
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            source field
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          4. context exact
            as a single agent for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy ( 1.2 )
            kind
            regimen
            polarity
            not_inferred
            span
            end
            442
            end exclusive
            true
            exact text
            as a single agent for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy ( 1
            label id
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          regulatory links
            schema version
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            source defined aliases
              source span
              end
              446
              end exclusive
              true
              exact text
              as a single agent for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy ( 1.2 )
              label id
              8a0ceb7f-ea10-4b90-97fb-530d5f2a0bd2
              offset unit
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              source url
              https://api.fda.gov/drug/label.json?search=id%3A%228a0ceb7f-ea10-4b90-97fb-530d5f2a0bd2%22
              spl effective date
              2026-07-23
              spl set id
              82e7921a-1e84-4988-9799-0ad7d19b2a75
              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
              non_oncology_or_unclear_candidate
              Passage 3 · positive indication candidate
              application numbers
              1. BLA761240
              brand names
              1. LOQTORZI
              classification reasons
              1. explicit_positive_indication_predicate
              2. tumor_or_malignant_hematology_words_in_positive_statement
              clinical review status
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              content role
              positive_indication_candidate
              context span
              end
              944
              end exclusive
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                      Preserved source evidence · Not medical advice