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LABELS · 292bb46c-e55a-4acf-9dd1-fbe684ad1363

IMJUDO

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
2026-08-31
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE IMJUDO is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated: • in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). ( 1.1 ) • in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. ( 1.2 ) 1.1 Hepatocellular Carcinoma IMJUDO, in combination with durvalumab, is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). 1.2 Non-Small Cell Lung Cancer (NSCLC) IMJUDO, in combination with durvalumab and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
Full extracted label fields
application numbers
  1. BLA761289
boxed warning exact
    brand names
    1. IMJUDO
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6690679c-be2f-4588-a2e4-89fff74dd6be
    generic names
    1. TREMELIMUMAB
    id
    292bb46c-e55a-4acf-9dd1-fbe684ad1363
    indications and usage exact
    1. 1 INDICATIONS AND USAGE IMJUDO is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated: • in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). ( 1.1 ) • in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. ( 1.2 ) 1.1 Hepatocellular Carcinoma IMJUDO, in combination with durvalumab, is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). 1.2 Non-Small Cell Lung Cancer (NSCLC) IMJUDO, in combination with durvalumab and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. AstraZeneca Pharmaceuticals LP
      matched search terms
      1. cancer
      2. carcinoma
      3. lymphoma
      4. tumor
      package ndcs
      1. 0310-4505-25
      2. 0310-4535-30
      product ndcs
      1. 0310-4505
      2. 0310-4535
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions ( 5.1 ) 08/2026
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      rxcuis
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00100.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
        100
        total
        830
        sha256
        fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
        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=100&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22292bb46c-e55a-4acf-9dd1-fbe684ad1363%22
        spl effective date
        2026-08-31
        spl effective time
        20260831
        spl set id
        6690679c-be2f-4588-a2e4-89fff74dd6be
        spl version
        15
        substance names
        1. TREMELIMUMAB
        uniis
        1. QEN1X95CIX
        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
          BLA761289
          payload
          all indexed label documents
          1. Appl No
            761289
            Application Docs Date
            2022-10-31 00:00:00
            Application Docs ID
            72513
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            761289
            Application Docs Date
            2022-11-01 00:00:00
            Application Docs ID
            72523
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            SUPPL
          3. Appl No
            761289
            Application Docs Date
            2023-06-15 00:00:00
            Application Docs ID
            74494
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            2
            Submission Type
            SUPPL
          4. Appl No
            761289
            Application Docs Date
            2024-01-26 00:00:00
            Application Docs ID
            77307
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            4
            Submission Type
            SUPPL
          5. Appl No
            761289
            Application Docs Date
            2026-09-01 00:00:00
            Application Docs ID
            87114
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            9
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            761289
            Review Priority
            PRIORITY
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2022-10-21 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            761289
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2022-10-28 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            761289
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            2
            Submission Status
            AP
            Submission Status Date
            2023-06-14 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            761289
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            4
            Submission Status
            AP
            Submission Status Date
            2024-01-25 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            761289
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            6
            Submission Status
            AP
            Submission Status Date
            2024-07-24 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            761289
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            9
            Submission Status
            AP
            Submission Status Date
            2026-08-31 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          BLA761289
          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
            761289
            Application Docs Date
            2026-09-01 00:00:00
            Application Docs ID
            87114
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            9
            Submission Type
            SUPPL
          official application record
          Appl No
          761289
          Appl Public Notes
          Appl Type
          BLA
          Sponsor Name
          ASTRAZENECA AB
          openfda application present
          true
          products
          1. Active Ingredient
            TREMELIMUMAB-ACTL
            Appl No
            761289
            Drug Name
            IMJUDO
            Form
            INJECTABLE;INTRAVENOUS
            Product No
            001
            Reference Drug
            0
            Reference Standard
            0
            Strength
            25MG/1.25ML(20MG/ML)
            marketing status
            1. Prescription
          2. Active Ingredient
            TREMELIMUMAB-ACTL
            Appl No
            761289
            Drug Name
            IMJUDO
            Form
            INJECTABLE;INTRAVENOUS
            Product No
            002
            Reference Drug
            0
            Reference Standard
            0
            Strength
            300MG/15ML(20MG/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 · indication intro context
        application numbers
        1. BLA761289
        brand names
        1. IMJUDO
        classification reasons
        1. explicit_positive_indication_predicate
        2. no_tumor_directed_keyword_in_positive_statement
        3. incomplete_colon_led_indication_intro
        clinical review status
        pending
        content role
        indication_intro_context
        context span
        end
        317
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE IMJUDO is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated: • in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). ( 1.1 ) • in combination with durvalumab and platinum-based chemotherapy for t
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        current approval status
        not_reconciled
        duplicate text group
        dup-6feb2461b378c08229c0
        extraction review status
        automated_candidate_pending_source_review
        generic names
        1. TREMELIMUMAB
        id
        ind-span-785f7faee10c13e0f37f
        label id
        292bb46c-e55a-4acf-9dd1-fbe684ad1363
        positive predicate support span
        end
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        end exclusive
        true
        exact text
        is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated
        label id
        292bb46c-e55a-4acf-9dd1-fbe684ad1363
        offset unit
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        source field
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        source text sha256
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        qualifier mentions
          regulatory links
            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
              398
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              true
              exact text
              non-small cell lung cancer (NSCLC)
              label id
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            true
            exact text
            1 INDICATIONS AND USAGE IMJUDO is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated:
            label id
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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%22292bb46c-e55a-4acf-9dd1-fbe684ad1363%22
            spl effective date
            2026-08-31
            spl set id
            6690679c-be2f-4588-a2e4-89fff74dd6be
            spl version
            15
            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
            not_applicable
            Passage 2 · positive indication candidate
            application numbers
            1. BLA761289
            brand names
            1. IMJUDO
            classification reasons
            1. inherited_predicate_from_same_label_section_requires_review
            2. tumor_or_malignant_hematology_words_in_positive_statement
            clinical review status
            pending
            content role
            positive_indication_candidate
            context span
            end
            438
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE IMJUDO is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated: • in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). ( 1.1 ) • in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth fa
            label id
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            source text sha256
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            current approval status
            not_reconciled
            duplicate text group
            dup-2290fa0d0c0712e88802
            extraction review status
            automated_candidate_pending_source_review
            generic names
            1. TREMELIMUMAB
            id
            ind-span-57bbdcfde9f3c7a67f69
            label id
            292bb46c-e55a-4acf-9dd1-fbe684ad1363
            positive predicate support span
            end
            116
            end exclusive
            true
            exact text
            is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated
            label id
            292bb46c-e55a-4acf-9dd1-fbe684ad1363
            offset unit
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            source field
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            source text sha256
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            qualifier mentions
            1. context exact
              • in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).
              kind
              age
              polarity
              not_inferred
              span
              end
              187
              end exclusive
              true
              exact text
              adult patients
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            2. context exact
              n with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).
              kind
              stage_or_setting
              polarity
              not_inferred
              span
              end
              237
              end exclusive
              true
              exact text
              unresectable hepatocellular carcinoma (uHCC)
              label id
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            3. context exact
              • in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).
              kind
              regimen
              polarity
              not_inferred
              span
              end
              237
              end exclusive
              true
              exact text
              in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC)
              label id
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            regulatory links
              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
                398
                end exclusive
                true
                exact text
                non-small cell lung cancer (NSCLC)
                label id
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              exact text
              • in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).
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              source url
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              spl effective date
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              spl set id
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              structured fields status
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              approval pathway
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              limitations
              Source null
              line
              Source null
              prior therapy
              Source null
              regimen
              Source null
              tumor histology
              Source null
              use intent
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              Passage 3 · unclassified context
              application numbers
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              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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              true
              exact text
              otoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated: • in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). ( 1.1 ) • in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor rec
              label id
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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
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              label id
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              positive predicate support span
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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
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                    end exclusive
                    true
                    exact text
                    non-small cell lung cancer (NSCLC)
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                  offset unit
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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
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                            in combination with durvalumab and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing epidermal growth factor
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                            1.2 Non-Small Cell Lung Cancer (NSCLC) IMJUDO, in combination with durvalumab and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
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                            spl effective date
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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
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                            Preserved source evidence · Not medical advice