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LABELS · 14431dcb-cda7-4ae4-aa2b-6480d6ac459f

ZALTRAP

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
2025-10-06
Captured
2026-09-09T23:37:39.774134+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE ZALTRAP, in combination with fluorouracil, leucovorin, irinotecan-(FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen. ZALTRAP, a vascular endothelial growth factor inhibitor, in combination with fluorouracil, leucovorin, irinotecan (FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer that is resistant to or has progressed following an oxaliplatin-containing regimen. ( 1 )
Full extracted label fields
application numbers
  1. BLA125418
boxed warning exact
    brand names
    1. ZALTRAP
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f6725df6-50ee-4b0a-b900-d02ba634395d
    generic names
    1. ZIV-AFLIBERCEPT
    id
    14431dcb-cda7-4ae4-aa2b-6480d6ac459f
    indications and usage exact
    1. 1 INDICATIONS AND USAGE ZALTRAP, in combination with fluorouracil, leucovorin, irinotecan-(FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen. ZALTRAP, a vascular endothelial growth factor inhibitor, in combination with fluorouracil, leucovorin, irinotecan (FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer that is resistant to or has progressed following an oxaliplatin-containing regimen. ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. sanofi-aventis U.S. LLC
      matched search terms
      1. cancer
      package ndcs
      1. 0024-5840-01
      2. 0024-5840-03
      3. 0024-5841-01
      product ndcs
      1. 0024-5840
      2. 0024-5841
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVENOUS
        rxcuis
        1. 1723187
        2. 1723189
        3. 1723193
        4. 1723194
        source batch
        file
        /private/tmp/cancer-full-research/indications/raw/labels-00000.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
        0
        total
        830
        sha256
        0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
        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=0&sort=id%3Aasc
        source url
        https://api.fda.gov/drug/label.json?search=id%3A%2214431dcb-cda7-4ae4-aa2b-6480d6ac459f%22
        spl effective date
        2025-10-06
        spl effective time
        20251006
        spl set id
        f6725df6-50ee-4b0a-b900-d02ba634395d
        spl version
        28
        substance names
        1. AFLIBERCEPT
        uniis
        1. 15C2VL427D
        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
          BLA125418
          payload
          all indexed label documents
          1. Appl No
            125418
            Application Docs Date
            2012-08-03 00:00:00
            Application Docs ID
            18911
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          2. Appl No
            125418
            Application Docs Date
            2016-03-14 00:00:00
            Application Docs ID
            18912
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            37
            Submission Type
            SUPPL
          3. Appl No
            125418
            Application Docs Date
            2013-10-31 00:00:00
            Application Docs ID
            39955
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            20
            Submission Type
            SUPPL
          4. Appl No
            125418
            Application Docs Date
            2016-06-27 00:00:00
            Application Docs ID
            39956
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            39
            Submission Type
            SUPPL
          5. Appl No
            125418
            Application Docs Date
            2019-11-29 00:00:00
            Application Docs ID
            61099
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            45
            Submission Type
            SUPPL
          6. Appl No
            125418
            Application Docs Date
            2020-03-12 00:00:00
            Application Docs ID
            62134
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            46
            Submission Type
            SUPPL
          7. Appl No
            125418
            Application Docs Date
            2020-06-08 00:00:00
            Application Docs ID
            63438
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            47
            Submission Type
            SUPPL
          8. Appl No
            125418
            Application Docs Date
            2023-12-14 00:00:00
            Application Docs ID
            76824
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            54
            Submission Type
            SUPPL
          all submission records
          1. Appl No
            125418
            Review Priority
            PRIORITY
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2012-08-03 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            125418
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            20
            Submission Status
            AP
            Submission Status Date
            2013-10-25 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            125418
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            33
            Submission Status
            AP
            Submission Status Date
            2015-09-17 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            125418
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            37
            Submission Status
            AP
            Submission Status Date
            2016-03-09 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            125418
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            39
            Submission Status
            AP
            Submission Status Date
            2016-06-24 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          6. Appl No
            125418
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            45
            Submission Status
            AP
            Submission Status Date
            2019-11-25 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          7. Appl No
            125418
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            46
            Submission Status
            AP
            Submission Status Date
            2020-03-11 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          8. Appl No
            125418
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            47
            Submission Status
            AP
            Submission Status Date
            2020-06-05 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          9. Appl No
            125418
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            54
            Submission Status
            AP
            Submission Status Date
            2023-12-13 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          BLA125418
          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
          2023-12-13
          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
            125418
            Application Docs Date
            2023-12-14 00:00:00
            Application Docs ID
            76824
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            54
            Submission Type
            SUPPL
          official application record
          Appl No
          125418
          Appl Public Notes
          Appl Type
          BLA
          Sponsor Name
          SANOFI AVENTIS US
          openfda application present
          true
          products
          1. Active Ingredient
            ZIV-AFLIBERCEPT
            Appl No
            125418
            Drug Name
            ZALTRAP
            Form
            INJECTABLE; INJECTION
            Product No
            001
            Reference Drug
            0
            Reference Standard
            Strength
            4MG
            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. BLA125418
        brand names
        1. ZALTRAP
        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
        468
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE ZALTRAP, in combination with fluorouracil, leucovorin, irinotecan-(FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen. ZALTRAP, a vascular endothelial growth factor inhibitor, in combination with fluorouracil, leucovorin, irinotecan (FOLFIRI), is indicated for the treatment of patients with metastatic colorectal canc
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        current approval status
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        duplicate text group
        dup-1f40aca71429f8846b95
        extraction review status
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        generic names
        1. ZIV-AFLIBERCEPT
        id
        ind-span-e8e931163304ddb6ab95
        label id
        14431dcb-cda7-4ae4-aa2b-6480d6ac459f
        positive predicate support span
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        end exclusive
        true
        exact text
        is indicated
        label id
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        source text sha256
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        qualifier mentions
        1. context exact
          -(FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-con
          kind
          biomarker
          polarity
          not_inferred
          span
          end
          192
          end exclusive
          true
          exact text
          metastatic colorectal cancer (mCRC) that is
          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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        2. context exact
          -(FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-conta
          kind
          stage_or_setting
          polarity
          not_inferred
          span
          end
          194
          end exclusive
          true
          exact text
          metastatic colorectal cancer (mCRC) that is r
          label id
          14431dcb-cda7-4ae4-aa2b-6480d6ac459f
          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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        3. context exact
          1 INDICATIONS AND USAGE ZALTRAP, in combination with fluorouracil, leucovorin, irinotecan-(FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen.
          kind
          regimen
          polarity
          not_inferred
          span
          end
          212
          end exclusive
          true
          exact text
          in combination with fluorouracil, leucovorin, irinotecan-(FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has
          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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        regulatory links
          schema version
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          source batch sha256
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          source defined aliases
            source span
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            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE ZALTRAP, in combination with fluorouracil, leucovorin, irinotecan-(FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen.
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            source field
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            source url
            https://api.fda.gov/drug/label.json?search=id%3A%2214431dcb-cda7-4ae4-aa2b-6480d6ac459f%22
            spl effective date
            2025-10-06
            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
            Passage 2 · positive indication candidate
            application numbers
            1. BLA125418
            brand names
            1. ZALTRAP
            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
            560
            end exclusive
            true
            exact text
            ucovorin, irinotecan-(FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen. ZALTRAP, a vascular endothelial growth factor inhibitor, in combination with fluorouracil, leucovorin, irinotecan (FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer that is resistant to or has progressed following an oxaliplatin-containing regimen. ( 1 )
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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
            1. ZIV-AFLIBERCEPT
            id
            ind-span-96e799ccacce144d5fb8
            label id
            14431dcb-cda7-4ae4-aa2b-6480d6ac459f
            positive predicate support span
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            true
            exact text
            is indicated
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            qualifier mentions
            1. context exact
              (FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer that is resistant to or has progressed following an oxaliplatin-containing
              kind
              biomarker
              polarity
              not_inferred
              span
              end
              485
              end exclusive
              true
              exact text
              metastatic colorectal cancer that is resist
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            2. context exact
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              kind
              stage_or_setting
              polarity
              not_inferred
              span
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              end exclusive
              true
              exact text
              metastatic colorectal cancer that is resistan
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            3. context exact
              ZALTRAP, a vascular endothelial growth factor inhibitor, in combination with fluorouracil, leucovorin, irinotecan (FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer that is resistant to or has progressed following an oxaliplatin-containing regimen.
              kind
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              span
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              505
              end exclusive
              true
              exact text
              in combination with fluorouracil, leucovorin, irinotecan (FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer that is resistant to or has progre
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              source field
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            regulatory links
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                true
                exact text
                ZALTRAP, a vascular endothelial growth factor inhibitor, in combination with fluorouracil, leucovorin, irinotecan (FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer that is resistant to or has progressed following an oxaliplatin-containing regimen.
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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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                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 3 · unclassified context
                application numbers
                1. BLA125418
                brand names
                1. ZALTRAP
                classification reasons
                1. no_unambiguous_positive_indication_predicate
                clinical review status
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                content role
                unclassified_context
                context span
                end
                560
                end exclusive
                true
                exact text
                cil, leucovorin, irinotecan (FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer that is resistant to or has progressed following an oxaliplatin-containing regimen. ( 1 )
                label id
                14431dcb-cda7-4ae4-aa2b-6480d6ac459f
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                current approval status
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                duplicate text group
                dup-7f314564f79f7686244f
                extraction review status
                automated_candidate_pending_source_review
                generic names
                1. ZIV-AFLIBERCEPT
                id
                ind-span-606dc7e859bb1c198792
                label id
                14431dcb-cda7-4ae4-aa2b-6480d6ac459f
                positive predicate support span
                Source null
                qualifier mentions
                  regulatory links
                    schema version
                    0.1.0
                    source batch sha256
                    0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
                    source defined aliases
                      source span
                      end
                      560
                      end exclusive
                      true
                      exact text
                      ( 1 )
                      label id
                      14431dcb-cda7-4ae4-aa2b-6480d6ac459f
                      offset unit
                      unicode_code_points
                      source array index
                      0
                      source field
                      indications_and_usage_exact
                      source text sha256
                      9a14e43cc6cff41ad8991e01e4baf440bab6aaddd473bef5aeb0aee76c632b92
                      start
                      555
                      source url
                      https://api.fda.gov/drug/label.json?search=id%3A%2214431dcb-cda7-4ae4-aa2b-6480d6ac459f%22
                      spl effective date
                      2025-10-06
                      spl set id
                      f6725df6-50ee-4b0a-b900-d02ba634395d
                      spl version
                      28
                      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