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LABELS · 15b86e86-8940-44e3-921c-2e0b97180ea1

LONSURF

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
2025-11-05
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 LONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indicated for the treatment of adult patients with: metastatic colorectal cancer as a single agent or in combination with bevacizumab who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. ( 1.1 ) metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. ( 1.2 ) 1.1 Metastatic Colorectal Cancer LONSURF, as a single agent or in combination with bevacizumab, is indicated for the treatment of adult patients with metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. 1.2 Metastatic Gastric Cancer LONSURF is indicated for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.
Full extracted label fields
application numbers
  1. NDA207981
boxed warning exact
    brand names
    1. LONSURF
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f5beed22-d71d-4c0d-8dca-2c7317d65d85
    generic names
    1. TRIFLURIDINE AND TIPIRACIL
    id
    15b86e86-8940-44e3-921c-2e0b97180ea1
    indications and usage exact
    1. 1 INDICATIONS AND USAGE LONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indicated for the treatment of adult patients with: metastatic colorectal cancer as a single agent or in combination with bevacizumab who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. ( 1.1 ) metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. ( 1.2 ) 1.1 Metastatic Colorectal Cancer LONSURF, as a single agent or in combination with bevacizumab, is indicated for the treatment of adult patients with metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. 1.2 Metastatic Gastric Cancer LONSURF is indicated for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Taiho Pharmaceutical Co., Ltd.
      matched search terms
      1. cancer
      package ndcs
      1. 64842-1025-1
      2. 64842-1025-2
      3. 64842-1025-3
      4. 64842-1020-1
      5. 64842-1020-2
      6. 64842-1020-3
      product ndcs
      1. 64842-1020
      2. 64842-1025
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Indications and Usage ( 1.1 ) 8/2023 Dosage and Administration ( 2 ) 8/2023 Warnings and Precaution ( 5.1 ) 8/2023
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 1670311
      2. 1670316
      3. 1670322
      4. 1670324
      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%2215b86e86-8940-44e3-921c-2e0b97180ea1%22
      spl effective date
      2025-11-05
      spl effective time
      20251105
      spl set id
      f5beed22-d71d-4c0d-8dca-2c7317d65d85
      spl version
      15
      substance names
      1. TRIFLURIDINE
      2. TIPIRACIL HYDROCHLORIDE
      uniis
      1. 4H59KLQ0A4
      2. RMW9V5RW38
      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
        NDA207981
        payload
        all indexed label documents
        1. Appl No
          207981
          Application Docs Date
          2015-09-22 00:00:00
          Application Docs ID
          40605
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          207981
          Application Docs Date
          2017-03-30 00:00:00
          Application Docs ID
          47809
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        3. Appl No
          207981
          Application Docs Date
          2017-06-30 00:00:00
          Application Docs ID
          48874
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        4. Appl No
          207981
          Application Docs Date
          2019-02-25 00:00:00
          Application Docs ID
          57809
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          8
          Submission Type
          SUPPL
        5. Appl No
          207981
          Application Docs Date
          2020-04-08 00:00:00
          Application Docs ID
          62508
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          9
          Submission Type
          SUPPL
        6. Appl No
          207981
          Application Docs Date
          2023-08-02 00:00:00
          Application Docs ID
          74972
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          12
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          207981
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          12
          Submission Status
          AP
          Submission Status Date
          2023-08-02 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          207981
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          9
          Submission Status
          AP
          Submission Status Date
          2020-01-01 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          207981
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          8
          Submission Status
          AP
          Submission Status Date
          2019-02-22 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          207981
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2017-06-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          207981
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          2017-03-30 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          207981
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2016-04-05 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          207981
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2015-11-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          207981
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2015-11-13 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          207981
          Review Priority
          STANDARD
          Submission Class Code ID
          8
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2015-09-22 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        application number
        NDA207981
        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
        2023-08-02
        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
          207981
          Application Docs Date
          2023-08-02 00:00:00
          Application Docs ID
          74972
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          12
          Submission Type
          SUPPL
        official application record
        Appl No
        207981
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        TAIHO ONCOLOGY
        openfda application present
        true
        products
        1. Active Ingredient
          TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE
          Appl No
          207981
          Drug Name
          LONSURF
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          EQ 6.14MG BASE;15MG
          marketing status
          1. Prescription
        2. Active Ingredient
          TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE
          Appl No
          207981
          Drug Name
          LONSURF
          Form
          TABLET;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 8.19MG BASE;20MG
          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. NDA207981
      brand names
      1. LONSURF
      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
      667
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE LONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indicated for the treatment of adult patients with: metastatic colorectal cancer as a single agent or in combination with bevacizumab who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. ( 1.1 ) metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane o
      label id
      15b86e86-8940-44e3-921c-2e0b97180ea1
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
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      start
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      current approval status
      not_reconciled
      duplicate text group
      dup-57727ad5f0a6f6a1f7bc
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. TRIFLURIDINE AND TIPIRACIL
      id
      ind-span-bf906b96302291159a18
      label id
      15b86e86-8940-44e3-921c-2e0b97180ea1
      positive predicate support span
      end
      165
      end exclusive
      true
      exact text
      indicated for
      label id
      15b86e86-8940-44e3-921c-2e0b97180ea1
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
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      start
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      qualifier mentions
      1. context exact
        ine phosphorylase inhibitor, indicated for the treatment of adult patients with: metastatic colorectal cancer as a single agent or in
        kind
        age
        polarity
        not_inferred
        span
        end
        197
        end exclusive
        true
        exact text
        adult patients
        label id
        15b86e86-8940-44e3-921c-2e0b97180ea1
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        61b83f8a7fd4d4293c2880a852c20fd877dd04dfcfee6709c0e8f8c1ef7700a3
        start
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      2. context exact
        SAGE LONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indica
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        98
        end exclusive
        true
        exact text
        metabolic inhibitor
        label id
        15b86e86-8940-44e3-921c-2e0b97180ea1
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        61b83f8a7fd4d4293c2880a852c20fd877dd04dfcfee6709c0e8f8c1ef7700a3
        start
        79
      3. context exact
        ibitor, indicated for the treatment of adult patients with: metastatic colorectal cancer as a single agent or in combination with bevacizumab who have been previou
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        247
        end exclusive
        true
        exact text
        metastatic colorectal cancer as a single ag
        label id
        15b86e86-8940-44e3-921c-2e0b97180ea1
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
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        start
        204
      4. context exact
        anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        466
        end exclusive
        true
        exact text
        EGFR therapy
        label id
        15b86e86-8940-44e3-921c-2e0b97180ea1
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        61b83f8a7fd4d4293c2880a852c20fd877dd04dfcfee6709c0e8f8c1ef7700a3
        start
        454
      5. context exact
        ibitor, indicated for the treatment of adult patients with: metastatic colorectal cancer as a single agent or in combination with bevacizumab who have been previousl
        kind
        stage_or_setting
        polarity
        not_inferred
        span
        end
        249
        end exclusive
        true
        exact text
        metastatic colorectal cancer as a single agen
        label id
        15b86e86-8940-44e3-921c-2e0b97180ea1
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
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        start
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      6. context exact
        ngle agent or in combination with bevacizumab who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.
        kind
        prior_therapy_or_line
        polarity
        not_inferred
        span
        end
        466
        end exclusive
        true
        exact text
        previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy
        label id
        15b86e86-8940-44e3-921c-2e0b97180ea1
        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
        300
      7. context exact
        atment of adult patients with: metastatic colorectal cancer as a single agent or in combination with bevacizumab who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.
        kind
        regimen
        polarity
        not_inferred
        span
        end
        410
        end exclusive
        true
        exact text
        as a single agent or in combination with bevacizumab who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biolog
        label id
        15b86e86-8940-44e3-921c-2e0b97180ea1
        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
        0.1.0
        source batch sha256
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        source defined aliases
          source span
          end
          467
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE LONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indicated for the treatment of adult patients with: metastatic colorectal cancer as a single agent or in combination with bevacizumab who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.
          label id
          15b86e86-8940-44e3-921c-2e0b97180ea1
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
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          start
          0
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%2215b86e86-8940-44e3-921c-2e0b97180ea1%22
          spl effective date
          2025-11-05
          spl set id
          f5beed22-d71d-4c0d-8dca-2c7317d65d85
          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
          tumor_directed_candidate
          Passage 2 · unclassified context
          application numbers
          1. NDA207981
          brand names
          1. LONSURF
          classification reasons
          1. no_unambiguous_positive_indication_predicate
          clinical review status
          pending
          content role
          unclassified_context
          context span
          end
          927
          end exclusive
          true
          exact text
          with bevacizumab who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. ( 1.1 ) metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. ( 1.2 ) 1.1 Metastatic Colorectal Cancer LONSURF, as a single agent or in combination with bevacizumab, is indicated for the treatment of adult patients with metastatic colorectal cancer previously t
          label id
          15b86e86-8940-44e3-921c-2e0b97180ea1
          offset unit
          unicode_code_points
          source array index
          0
          source field
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          source text sha256
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          current approval status
          not_reconciled
          duplicate text group
          dup-25ed8814a8700f87cb28
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. TRIFLURIDINE AND TIPIRACIL
          id
          ind-span-82bcc82b653bf4320d58
          label id
          15b86e86-8940-44e3-921c-2e0b97180ea1
          positive predicate support span
          Source null
          qualifier mentions
          1. context exact
            ( 1.1 ) metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two pri
            kind
            biomarker
            polarity
            not_inferred
            span
            end
            519
            end exclusive
            true
            exact text
            metastatic gastric or gastroesophageal junc
            label id
            15b86e86-8940-44e3-921c-2e0b97180ea1
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
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            start
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                            exact text
                            1.2 Metastatic Gastric Cancer LONSURF is indicated for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.
                            label id
                            15b86e86-8940-44e3-921c-2e0b97180ea1
                            offset unit
                            unicode_code_points
                            source array index
                            0
                            source field
                            indications_and_usage_exact
                            source text sha256
                            61b83f8a7fd4d4293c2880a852c20fd877dd04dfcfee6709c0e8f8c1ef7700a3
                            start
                            1083
                            source url
                            https://api.fda.gov/drug/label.json?search=id%3A%2215b86e86-8940-44e3-921c-2e0b97180ea1%22
                            spl effective date
                            2025-11-05
                            spl set id
                            f5beed22-d71d-4c0d-8dca-2c7317d65d85
                            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
                            tumor_directed_candidate

                            Preserved source evidence · Not medical advice