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LABELS · 6bd41585-62b9-4761-859b-759672bfd679

ZYNLONTA

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
2026-06-12
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE ZYNLONTA is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma. This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ZYNLONTA is a CD19-directed antibody and alkylating agent conjugate indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma. ( 1 ) This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )
Full extracted label fields
application numbers
  1. BLA761196
boxed warning exact
    brand names
    1. ZYNLONTA
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=af54af12-3edf-4301-8bc5-0446bc813c1d
    generic names
    1. LONCASTUXIMAB TESIRINE
    id
    6bd41585-62b9-4761-859b-759672bfd679
    indications and usage exact
    1. 1 INDICATIONS AND USAGE ZYNLONTA is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma. This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ZYNLONTA is a CD19-directed antibody and alkylating agent conjugate indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma. ( 1 ) This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. ADC Therapeutics America, Inc.
      matched search terms
      1. lymphoma
      package ndcs
      1. 79952-110-01
      product ndcs
      1. 79952-110
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Dosage and Administration ( 2.3 ) 2/2026 Warnings and Precautions, Effusion and Edema, Including Capillary Leak Syndrome ( 5.1 ) 2/2026 Warnings and Precautions, Hepatotoxicity, Including Drug-Induced Liver Injury ( 5.4 ) 1/2026
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      rxcuis
      1. 2540969
      2. 2540974
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00400.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
      400
      total
      830
      sha256
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      url
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      source url
      https://api.fda.gov/drug/label.json?search=id%3A%226bd41585-62b9-4761-859b-759672bfd679%22
      spl effective date
      2026-06-12
      spl effective time
      20260612
      spl set id
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      spl version
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      substance names
      1. LONCASTUXIMAB TESIRINE
      uniis
      1. 7K5O7P6QIU
      verification flags
      1. oncology_keyword_candidate_not_clinically_classified
      2. spl_text_not_verified_identical_to_latest_approved_label
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      Drugs@FDA application source records
      1. application number
        BLA761196
        payload
        all indexed label documents
        1. Appl No
          761196
          Application Docs Date
          2021-04-23 00:00:00
          Application Docs ID
          67161
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          761196
          Application Docs Date
          2022-10-17 00:00:00
          Application Docs ID
          72397
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
          SUPPL
        3. Appl No
          761196
          Application Docs Date
          2022-10-17 00:00:00
          Application Docs ID
          72398
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        4. Appl No
          761196
          Application Docs Date
          2026-01-21 00:00:00
          Application Docs ID
          84802
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          12
          Submission Type
          SUPPL
        5. Appl No
          761196
          Application Docs Date
          2026-02-24 00:00:00
          Application Docs ID
          85144
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          13
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          761196
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2021-04-23 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          761196
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          2022-10-12 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          761196
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5
          Submission Status
          AP
          Submission Status Date
          2022-10-12 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          761196
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          12
          Submission Status
          AP
          Submission Status Date
          2026-01-16 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          761196
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          13
          Submission Status
          AP
          Submission Status Date
          2026-02-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        BLA761196
        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
        2026-02-20
        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
          761196
          Application Docs Date
          2026-02-24 00:00:00
          Application Docs ID
          85144
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          13
          Submission Type
          SUPPL
        official application record
        Appl No
        761196
        Appl Public Notes
        Appl Type
        BLA
        Sponsor Name
        ADC Therapeutics SA
        openfda application present
        true
        products
        1. Active Ingredient
          LONCASTUXIMAB TESIRINE-LPYL
          Appl No
          761196
          Drug Name
          ZYNLONTA
          Form
          INJECTABLE;INJECTION
          Product No
          001
          Reference Drug
          0
          Reference Standard
          0
          Strength
          10MG
          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. BLA761196
      brand names
      1. ZYNLONTA
      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
      520
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE ZYNLONTA is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma. This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and d
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      end exclusive
      true
      exact text
      is indicated
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      qualifier mentions
      1. context exact
        ATIONS AND USAGE ZYNLONTA is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two
        kind
        age
        polarity
        not_inferred
        span
        end
        81
        end exclusive
        true
        exact text
        adult patients
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      2. context exact
        LONTA is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including dif
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        stage_or_setting
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        not_inferred
        span
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        end exclusive
        true
        exact text
        relapsed or refractory large B-cell lymphom
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      regulatory links
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        source batch sha256
        a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
        source defined aliases
        1. abbreviation
          DLBCL
          definition exact
          diffuse large B-cell lymphoma
          definition span
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          end exclusive
          true
          exact text
          diffuse large B-cell lymphoma (DLBCL)
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        exact text
        1 INDICATIONS AND USAGE ZYNLONTA is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma.
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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
        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 · approval contingency
        application numbers
        1. BLA761196
        brand names
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        classification reasons
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        clinical review status
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        exact text
        l lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma. This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ZYNLONTA is a CD19-directed antibody and alkylating agent co
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        offset unit
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        source array index
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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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        label id
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        positive predicate support span
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            source defined aliases
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              definition exact
              diffuse large B-cell lymphoma
              definition span
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              end exclusive
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              exact text
              diffuse large B-cell lymphoma (DLBCL)
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            This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.1) ] .
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            source url
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            pecified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma. This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ZYNLONTA is a CD19-directed antibody and alkylating agent conjugate indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic
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                Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
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                Passage 4 · positive indication candidate
                application numbers
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                brand names
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                exact text
                ed on overall response rate [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ZYNLONTA is a CD19-directed antibody and alkylating agent conjugate indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma. ( 1 ) This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical ben
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