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LABELS · f0a8a9ab-8203-47aa-abbe-54614c201d48

ONCASPAR

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
2024-10-07
Captured
2026-09-09T23:38:04.335995+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE ONCASPAR is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for treatment of pediatric and adult patients with: First-line acute lymphoblastic leukemia ( 1.1 ) Acute lymphoblastic leukemia and hypersensitivity to asparaginase ( 1.2 ) 1.1 First Line Acute Lymphoblastic Leukemia (ALL) ONCASPAR ® is indicated as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of pediatric and adult patients with ALL. 1.2 Acute Lymphoblastic Leukemia and Hypersensitivity to Asparaginase ONCASPAR is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with ALL and hypersensitivity to native forms of L-asparaginase.
Full extracted label fields
application numbers
  1. BLA103411
boxed warning exact
    brand names
    1. ONCASPAR
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac7b6a6f-6ddb-48c6-8088-d8a8e3fea6ce
    generic names
    1. PEGASPARGASE
    id
    f0a8a9ab-8203-47aa-abbe-54614c201d48
    indications and usage exact
    1. 1 INDICATIONS AND USAGE ONCASPAR is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for treatment of pediatric and adult patients with: First-line acute lymphoblastic leukemia ( 1.1 ) Acute lymphoblastic leukemia and hypersensitivity to asparaginase ( 1.2 ) 1.1 First Line Acute Lymphoblastic Leukemia (ALL) ONCASPAR ® is indicated as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of pediatric and adult patients with ALL. 1.2 Acute Lymphoblastic Leukemia and Hypersensitivity to Asparaginase ONCASPAR is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with ALL and hypersensitivity to native forms of L-asparaginase.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Servier Pharmaceuticals LLC
      matched search terms
      1. leukemia
      package ndcs
      1. 72694-954-01
      product ndcs
      1. 72694-954
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions ( 5.6 ) 3/2024
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAMUSCULAR
      2. INTRAVENOUS
      rxcuis
      1. 213040
      2. 240906
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00800.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
      800
      total
      830
      sha256
      8c4843bd18fc22d01ea4a91909737f3bbfdde09c17c5b243ce13d05c406cc6c7
      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=800&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%22f0a8a9ab-8203-47aa-abbe-54614c201d48%22
      spl effective date
      2024-10-07
      spl effective time
      20241007
      spl set id
      ac7b6a6f-6ddb-48c6-8088-d8a8e3fea6ce
      spl version
      13
      substance names
      1. PEGASPARGASE
      uniis
      1. 7D96IR0PPM
      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
        BLA103411
        payload
        all indexed label documents
        1. Appl No
          103411
          Application Docs Date
          2006-07-24 00:00:00
          Application Docs ID
          18578
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5052
          Submission Type
          SUPPL
        2. Appl No
          103411
          Application Docs Date
          2011-12-12 00:00:00
          Application Docs ID
          18579
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5126
          Submission Type
          SUPPL
        3. Appl No
          103411
          Application Docs Date
          2014-04-23 00:00:00
          Application Docs ID
          18580
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5180
          Submission Type
          SUPPL
        4. Appl No
          103411
          Application Docs Date
          2016-10-12 00:00:00
          Application Docs ID
          45606
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5188
          Submission Type
          SUPPL
        5. Appl No
          103411
          Application Docs Date
          2019-01-11 00:00:00
          Application Docs ID
          57193
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5196
          Submission Type
          SUPPL
        6. Appl No
          103411
          Application Docs Date
          2020-06-19 00:00:00
          Application Docs ID
          63639
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5198
          Submission Type
          SUPPL
        7. Appl No
          103411
          Application Docs Date
          2021-11-03 00:00:00
          Application Docs ID
          69222
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5201
          Submission Type
          SUPPL
        8. Appl No
          103411
          Application Docs Date
          2022-12-27 00:00:00
          Application Docs ID
          73049
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5205
          Submission Type
          SUPPL
        9. Appl No
          103411
          Application Docs Date
          2024-03-14 00:00:00
          Application Docs ID
          77828
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5207
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          103411
          Review Priority
          UNKNOWN
          Submission Class Code ID
          12
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          1994-02-01 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          103411
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          5052
          Submission Status
          AP
          Submission Status Date
          2006-07-24 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          103411
          Review Priority
          Submission Class Code ID
          6
          Submission No
          5126
          Submission Status
          AP
          Submission Status Date
          2011-03-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          103411
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5180
          Submission Status
          AP
          Submission Status Date
          2014-04-22 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          103411
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5188
          Submission Status
          AP
          Submission Status Date
          2016-10-07 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          103411
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          5196
          Submission Status
          AP
          Submission Status Date
          2019-01-03 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          103411
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5198
          Submission Status
          AP
          Submission Status Date
          2020-06-17 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          103411
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5201
          Submission Status
          AP
          Submission Status Date
          2021-11-02 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          103411
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5205
          Submission Status
          AP
          Submission Status Date
          2022-12-22 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          103411
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5207
          Submission Status
          AP
          Submission Status Date
          2024-03-13 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        BLA103411
        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
        2024-03-13
        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
          103411
          Application Docs Date
          2024-03-14 00:00:00
          Application Docs ID
          77828
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5207
          Submission Type
          SUPPL
        official application record
        Appl No
        103411
        Appl Public Notes
        Appl Type
        BLA
        Sponsor Name
        SIGMA TAU
        openfda application present
        true
        products
        1. Active Ingredient
          PEGASPARGASE
          Appl No
          103411
          Drug Name
          ONCASPAR
          Form
          VIAL
          Product No
          001
          Reference Drug
          0
          Reference Standard
          Strength
          750IU/VIAL
          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. BLA103411
      brand names
      1. ONCASPAR
      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
      506
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE ONCASPAR is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for treatment of pediatric and adult patients with: First-line acute lymphoblastic leukemia ( 1.1 ) Acute lymphoblastic leukemia and hypersensitivity to asparaginase ( 1.2 ) 1.1 First Line Acute Lymphoblastic Leukemia (ALL) ONCASPAR ® is indicated as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of pediatric and adult patients with AL
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      not_reconciled
      duplicate text group
      dup-58384ba0a12869edcafb
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. PEGASPARGASE
      id
      ind-span-652eb2d62f5e2760c4a9
      label id
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      positive predicate support span
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      is an asparagine specific enzyme indicated
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      qualifier mentions
      1. context exact
        of a multi-agent chemotherapeutic regimen for treatment of pediatric and adult patients with: First-line acute lymphoblastic leu
        kind
        age
        polarity
        not_inferred
        span
        end
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        end exclusive
        true
        exact text
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        source text sha256
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      2. context exact
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      3. context exact
        regimen for treatment of pediatric and adult patients with: First-line acute lymphoblastic leukemia ( 1.1 ) Acute lymphoblastic leukemia and hypersensitivity to as
        kind
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        end exclusive
        true
        exact text
        First-line acute lymphoblastic leukemia ( 1
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      regulatory links
        schema version
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        source defined aliases
          source span
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          true
          exact text
          1 INDICATIONS AND USAGE ONCASPAR is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for treatment of pediatric and adult patients with: First-line acute lymphoblastic leukemia ( 1.1 ) Acute lymphoblastic leukemia and hypersensitivity to asparaginase ( 1.2 )
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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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          biomarker and test
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          disease stage
          Source null
          limitations
          Source null
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          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. BLA103411
          brand names
          1. ONCASPAR
          classification reasons
          1. explicit_positive_indication_predicate
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          clinical review status
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          true
          exact text
          chemotherapeutic regimen for treatment of pediatric and adult patients with: First-line acute lymphoblastic leukemia ( 1.1 ) Acute lymphoblastic leukemia and hypersensitivity to asparaginase ( 1.2 ) 1.1 First Line Acute Lymphoblastic Leukemia (ALL) ONCASPAR ® is indicated as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of pediatric and adult patients with ALL. 1.2 Acute Lymphoblastic Leukemia and Hypersensitivity to Asparaginase ONCASPAR is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients
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          3. context exact
            1.1 First Line Acute Lymphoblastic Leukemia (ALL) ONCASPAR ® is indicated as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of pediatric and adult patients with ALL.
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            end exclusive
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            First Line Acute Lymphoblastic Leukemia (ALL) ONCASPAR ® is indicated as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of pediatric a
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              1.1 First Line Acute Lymphoblastic Leukemia (ALL) ONCASPAR ® is indicated as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of pediatric and adult patients with ALL.
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              source url
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              spl effective date
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              biomarker and test
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              disease stage
              Source null
              limitations
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              Source null
              prior therapy
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              regimen
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              tumor histology
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              use intent
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              application numbers
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              brand names
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              classification reasons
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              2. tumor_or_malignant_hematology_words_in_positive_statement
              clinical review status
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              content role
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              true
              exact text
              1 First Line Acute Lymphoblastic Leukemia (ALL) ONCASPAR ® is indicated as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of pediatric and adult patients with ALL. 1.2 Acute Lymphoblastic Leukemia and Hypersensitivity to Asparaginase ONCASPAR is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with ALL and hypersensitivity to native forms of L-asparaginase.
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              1. PEGASPARGASE
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                chemotherapeutic regimen for the treatment of pediatric and adult patients with ALL and hypersensitivity to native forms of L-asparagi
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                  1.2 Acute Lymphoblastic Leukemia and Hypersensitivity to Asparaginase ONCASPAR is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with ALL and hypersensitivity to native forms of L-asparaginase.
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                  source url
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                  structured fields status
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                  Source null
                  approval pathway
                  Source null
                  biomarker and test
                  Source null
                  disease stage
                  Source null
                  limitations
                  Source null
                  line
                  Source null
                  prior therapy
                  Source null
                  regimen
                  Source null
                  tumor histology
                  Source null
                  use intent
                  tumor_directed_candidate

                  Preserved source evidence · Not medical advice