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LABELS · 869b812d-b22d-49ed-9d86-c30e4a014a9d

VYLOY

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
2026-08-11
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 VYLOY, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)‑negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test [see Dosage and Administration ( 2.1 ) and Clinical Studies ( 14 )]. VYLOY is a claudin 18.2-directed cytolytic antibody and is indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test ( 1 ).
Full extracted label fields
application numbers
  1. BLA761365
boxed warning exact
    brand names
    1. VYLOY
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e7695a21-abb6-47ac-93f8-0ece5a9c4409
    generic names
    1. ZOLBETUXIMAB
    id
    869b812d-b22d-49ed-9d86-c30e4a014a9d
    indications and usage exact
    1. 1 INDICATIONS AND USAGE VYLOY, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)‑negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test [see Dosage and Administration ( 2.1 ) and Clinical Studies ( 14 )]. VYLOY is a claudin 18.2-directed cytolytic antibody and is indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test ( 1 ).
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Astellas Pharma US, Inc.
      matched search terms
      1. tumors
      package ndcs
      1. 0469-3425-10
      2. 0469-4425-30
      product ndcs
      1. 0469-3425
      2. 0469-4425
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVENOUS
        rxcuis
          source batch
          file
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          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
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          skip
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          total
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          sha256
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          url
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          source url
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          spl effective date
          2026-08-11
          spl effective time
          20260811
          spl set id
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          spl version
          5
          substance names
          1. ZOLBETUXIMAB
          uniis
          1. TF5MPQ8WGY
          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
            BLA761365
            payload
            all indexed label documents
            1. Appl No
              761365
              Application Docs Date
              2024-10-18 00:00:00
              Application Docs ID
              79913
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              1
              Submission Type
              ORIG
            2. Appl No
              761365
              Application Docs Date
              2025-06-09 00:00:00
              Application Docs ID
              82492
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              3
              Submission Type
              SUPPL
            all submission records
            1. Appl No
              761365
              Review Priority
              STANDARD
              Submission Class Code ID
              2
              Submission No
              3
              Submission Status
              AP
              Submission Status Date
              2025-06-06 00:00:00
              Submission Type
              SUPPL
              Submissions Public Notes
            2. Appl No
              761365
              Review Priority
              PRIORITY
              Submission Class Code ID
              7
              Submission No
              1
              Submission Status
              AP
              Submission Status Date
              2024-10-18 00:00:00
              Submission Type
              ORIG
              Submissions Public Notes
            application number
            BLA761365
            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
            2025-06-06
            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
              761365
              Application Docs Date
              2025-06-09 00:00:00
              Application Docs ID
              82492
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
              3
              Submission Type
              SUPPL
            official application record
            Appl No
            761365
            Appl Public Notes
            Appl Type
            BLA
            Sponsor Name
            ASTELLAS
            openfda application present
            true
            products
            1. Active Ingredient
              ZOLBETUXIMAB-CLZB
              Appl No
              761365
              Drug Name
              VYLOY
              Form
              INJECTABLE;INJECTION
              Product No
              001
              Reference Drug
              0
              Reference Standard
              0
              Strength
              100MG
              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. BLA761365
          brand names
          1. VYLOY
          classification reasons
          1. explicit_positive_indication_predicate
          2. tumor_or_malignant_hematology_words_in_positive_statement
          clinical review status
          pending
          content role
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          context span
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          675
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          true
          exact text
          1 INDICATIONS AND USAGE VYLOY, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)‑negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test [see Dosage and Administration ( 2.1 ) and Clinical Studies ( 14 )]. VYLOY is a claudin 18.2-directed cytolytic antibody and is indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally adv
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          duplicate text group
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          generic names
          1. ZOLBETUXIMAB
          id
          ind-span-729c1971ba54b9f7cd1b
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          qualifier mentions
          1. context exact
            chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic human epid
            kind
            age
            polarity
            not_inferred
            span
            end
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          2. context exact
            e treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)‑negative gastric or gastroesophageal junctio
            kind
            biomarker
            polarity
            not_inferred
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            metastatic human epidermal growth factor re
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          3. context exact
            ble or metastatic human epidermal growth factor receptor 2 (HER2)‑negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN)
            kind
            biomarker
            polarity
            not_inferred
            span
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            exact text
            HER2)‑negative gastric or gastroesophageal j
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          4. context exact
            y, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)‑negative gastric or
            kind
            stage_or_setting
            polarity
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            locally advanced unresectable or metastatic human e
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          5. context exact
            and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)‑negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.
            kind
            prior_therapy_or_line
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            true
            exact text
            first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)‑negative gastric or gastroesophageal junct
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          6. context exact
            1 INDICATIONS AND USAGE VYLOY, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)‑negative gastr
            kind
            regimen
            polarity
            not_inferred
            span
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            210
            end exclusive
            true
            exact text
            in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic hu
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          regulatory links
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              1 INDICATIONS AND USAGE VYLOY, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)‑negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test [see Dosage and Administration ( 2.1 ) and Clinical Studies ( 14 )].
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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
              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. BLA761365
              brand names
              1. VYLOY
              classification reasons
              1. explicit_positive_indication_predicate
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              clinical review status
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              exact text
              gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test [see Dosage and Administration ( 2.1 ) and Clinical Studies ( 14 )]. VYLOY is a claudin 18.2-directed cytolytic antibody and is indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test ( 1 ).
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                e treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junctio
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              4. context exact
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              5. context exact
                oropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN) 18.2 posi
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                first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junct
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              6. context exact
                a claudin 18.2-directed cytolytic antibody and is indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroes
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                in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal
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                  VYLOY is a claudin 18.2-directed cytolytic antibody and is indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test ( 1 ).
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                  source url
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                  spl effective date
                  2026-08-11
                  spl set id
                  e7695a21-abb6-47ac-93f8-0ece5a9c4409
                  spl version
                  5
                  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