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LABELS · 22da60ef-4135-4bd5-8af1-6d10b7879a0b

asparlas

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
2024-10-08
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE ASPARLAS is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years. ( 1.1 ) 1.1 Acute Lymphoblastic Leukemia ASPARLAS is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years.
Full extracted label fields
application numbers
  1. BLA761102
boxed warning exact
    brand names
    1. asparlas
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6585bd0d-bd78-4341-9e87-0f7664821f05
    generic names
    1. CALASPARGASE PEGOL
    id
    22da60ef-4135-4bd5-8af1-6d10b7879a0b
    indications and usage exact
    1. 1 INDICATIONS AND USAGE ASPARLAS is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years. ( 1.1 ) 1.1 Acute Lymphoblastic Leukemia ASPARLAS is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Servier Pharmaceuticals LLC
      matched search terms
      1. leukemia
      package ndcs
      1. 72694-515-01
      product ndcs
      1. 72694-515
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Warnings and Precautions: Hepatotoxicity ( 5.5 ) 11/2023
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      rxcuis
      1. 2121421
      2. 2121426
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00100.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
      100
      total
      830
      sha256
      fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
      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=100&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%2222da60ef-4135-4bd5-8af1-6d10b7879a0b%22
      spl effective date
      2024-10-08
      spl effective time
      20241008
      spl set id
      6585bd0d-bd78-4341-9e87-0f7664821f05
      spl version
      12
      substance names
      1. CALASPARGASE PEGOL
      uniis
      1. T9FVH03HMZ
      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
        BLA761102
        payload
        all indexed label documents
        1. Appl No
          761102
          Application Docs Date
          2018-12-20 00:00:00
          Application Docs ID
          56832
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          761102
          Application Docs Date
          2019-09-05 00:00:00
          Application Docs ID
          59921
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        3. Appl No
          761102
          Application Docs Date
          2020-06-25 00:00:00
          Application Docs ID
          63696
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        4. Appl No
          761102
          Application Docs Date
          2021-12-23 00:00:00
          Application Docs ID
          69753
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          8
          Submission Type
          SUPPL
        5. Appl No
          761102
          Application Docs Date
          2023-11-30 00:00:00
          Application Docs ID
          76703
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          13
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          761102
          Review Priority
          STANDARD
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2018-12-20 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          761102
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2019-09-05 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          761102
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2020-06-24 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          761102
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          8
          Submission Status
          AP
          Submission Status Date
          2021-12-21 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          761102
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          13
          Submission Status
          AP
          Submission Status Date
          2023-11-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        BLA761102
        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
        2023-11-29
        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
          761102
          Application Docs Date
          2023-11-30 00:00:00
          Application Docs ID
          76703
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          13
          Submission Type
          SUPPL
        official application record
        Appl No
        761102
        Appl Public Notes
        Appl Type
        BLA
        Sponsor Name
        SERVIER PHARMA LLC
        openfda application present
        true
        products
        1. Active Ingredient
          CALASPARGASE PEGOL-MKNL
          Appl No
          761102
          Drug Name
          ASPARLAS
          Form
          INJECTABLE;INTRAVENOUS
          Product No
          001
          Reference Drug
          0
          Reference Standard
          0
          Strength
          3750UNITS/5ML
          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. BLA761102
      brand names
      1. asparlas
      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
      445
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE ASPARLAS is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years. ( 1.1 ) 1.1 Acute Lymphoblastic Leukemia ASPARLAS is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult
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      offset unit
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      source text sha256
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      start
      0
      current approval status
      not_reconciled
      duplicate text group
      dup-285128591dbc26c7f9a0
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. CALASPARGASE PEGOL
      id
      ind-span-e92a8f554d09d4098cb0
      label id
      22da60ef-4135-4bd5-8af1-6d10b7879a0b
      positive predicate support span
      end
      75
      end exclusive
      true
      exact text
      is an asparagine specific enzyme indicated
      label id
      22da60ef-4135-4bd5-8af1-6d10b7879a0b
      offset unit
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      source text sha256
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      qualifier mentions
      1. context exact
        egimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years.
        kind
        age
        polarity
        not_inferred
        span
        end
        195
        end exclusive
        true
        exact text
        pediatric
        label id
        22da60ef-4135-4bd5-8af1-6d10b7879a0b
        offset unit
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        source array index
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        source text sha256
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      2. context exact
        ment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years.
        kind
        age
        polarity
        not_inferred
        span
        end
        220
        end exclusive
        true
        exact text
        adult patients
        label id
        22da60ef-4135-4bd5-8af1-6d10b7879a0b
        offset unit
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        0
        source field
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        source text sha256
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        start
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      3. context exact
        ymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years.
        kind
        age
        polarity
        not_inferred
        span
        end
        244
        end exclusive
        true
        exact text
        age 1 month to 21 years
        label id
        22da60ef-4135-4bd5-8af1-6d10b7879a0b
        offset unit
        unicode_code_points
        source array index
        0
        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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          245
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE ASPARLAS is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years.
          label id
          22da60ef-4135-4bd5-8af1-6d10b7879a0b
          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
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          source url
          https://api.fda.gov/drug/label.json?search=id%3A%2222da60ef-4135-4bd5-8af1-6d10b7879a0b%22
          spl effective date
          2024-10-08
          spl set id
          6585bd0d-bd78-4341-9e87-0f7664821f05
          spl version
          12
          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. BLA761102
          brand names
          1. asparlas
          classification reasons
          1. no_unambiguous_positive_indication_predicate
          clinical review status
          pending
          content role
          unclassified_context
          context span
          end
          453
          end exclusive
          true
          exact text
          ine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years. ( 1.1 ) 1.1 Acute Lymphoblastic Leukemia ASPARLAS is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients
          label id
          22da60ef-4135-4bd5-8af1-6d10b7879a0b
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
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          current approval status
          not_reconciled
          duplicate text group
          dup-b417a97f011116cf9626
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. CALASPARGASE PEGOL
          id
          ind-span-c75835d922f28f024737
          label id
          22da60ef-4135-4bd5-8af1-6d10b7879a0b
          positive predicate support span
          Source null
          qualifier mentions
            regulatory links
              schema version
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              source batch sha256
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              source defined aliases
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                end exclusive
                true
                exact text
                ( 1.1 )
                label id
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                source text sha256
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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
                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
                Passage 3 · positive indication candidate
                application numbers
                1. BLA761102
                brand names
                1. asparlas
                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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                478
                end exclusive
                true
                exact text
                ific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years. ( 1.1 ) 1.1 Acute Lymphoblastic Leukemia ASPARLAS is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years.
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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. CALASPARGASE PEGOL
                id
                ind-span-53fe5e6e61deb298b411
                label id
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                positive predicate support span
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                end exclusive
                true
                exact text
                is indicated
                label id
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                1. context exact
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                  kind
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                  polarity
                  not_inferred
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                  end exclusive
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                  exact text
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                2. context exact
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                  kind
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                  end exclusive
                  true
                  exact text
                  adult patients
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                  offset unit
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                3. context exact
                  ymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years.
                  kind
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                  span
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                  end exclusive
                  true
                  exact text
                  age 1 month to 21 years
                  label id
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                  offset unit
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                regulatory links
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                  source defined aliases
                    source span
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                    end exclusive
                    true
                    exact text
                    1.1 Acute Lymphoblastic Leukemia ASPARLAS is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years.
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                    offset unit
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                    source field
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                    source text sha256
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                    source url
                    https://api.fda.gov/drug/label.json?search=id%3A%2222da60ef-4135-4bd5-8af1-6d10b7879a0b%22
                    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

                    Preserved source evidence · Not medical advice