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LABELS · e850e390-b32e-4382-a2c7-d480c41bd3a6

Daurismo

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
2025-12-12
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: EMBRYO-FETAL TOXICITY DAURISMO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. DAURISMO is embryotoxic, fetotoxic, and teratogenic in animals [see Warnings and Precautions (5.1) , Use in Specific Populations (8.1) ] . Conduct pregnancy testing in females of reproductive potential prior to initiation of DAURISMO treatment. Advise females of reproductive potential to use effective contraception during treatment with DAURISMO and for at least 30 days after the last dose [see Warnings and Precautions (5.1) , Use in Specific Populations (8.1 , 8.3) ] . Advise males of the potential risk of DAURISMO exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential during treatment with DAURISMO and for at least 30 days after the last dose to avoid potential drug exposure [see Warnings and Precautions (5.1) , Use in Specific Populations (8.3) ] . WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. • DAURISMO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. DAURISMO is embryotoxic, fetotoxic, and teratogenic in animals. ( 5.1 , 8.1 ) • Conduct pregnancy testing in females of reproductive potential prior to initiation of DAURISMO treatment. Advise females of reproductive potential to use effective contraception during treatment with DAURISMO and for at least 30 days after the last dose. ( 5.1 , 8.1 , 8.3 ) • Advise males of the potential risk of exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential during treatment with DAURISMO and for at least 30 days after the last dose to avoid potential drug exposure. ( 5.1 , 8.3 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE DAURISMO is indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy. DAURISMO is a hedgehog pathway inhibitor indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy. ( 1 )
Full extracted label fields
application numbers
  1. NDA210656
boxed warning exact
  1. WARNING: EMBRYO-FETAL TOXICITY DAURISMO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. DAURISMO is embryotoxic, fetotoxic, and teratogenic in animals [see Warnings and Precautions (5.1) , Use in Specific Populations (8.1) ] . Conduct pregnancy testing in females of reproductive potential prior to initiation of DAURISMO treatment. Advise females of reproductive potential to use effective contraception during treatment with DAURISMO and for at least 30 days after the last dose [see Warnings and Precautions (5.1) , Use in Specific Populations (8.1 , 8.3) ] . Advise males of the potential risk of DAURISMO exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential during treatment with DAURISMO and for at least 30 days after the last dose to avoid potential drug exposure [see Warnings and Precautions (5.1) , Use in Specific Populations (8.3) ] . WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. • DAURISMO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. DAURISMO is embryotoxic, fetotoxic, and teratogenic in animals. ( 5.1 , 8.1 ) • Conduct pregnancy testing in females of reproductive potential prior to initiation of DAURISMO treatment. Advise females of reproductive potential to use effective contraception during treatment with DAURISMO and for at least 30 days after the last dose. ( 5.1 , 8.1 , 8.3 ) • Advise males of the potential risk of exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential during treatment with DAURISMO and for at least 30 days after the last dose to avoid potential drug exposure. ( 5.1 , 8.3 )
brand names
  1. Daurismo
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=204a6f7e-c9a4-472b-abd2-9527bda64d17
generic names
  1. GLASDEGIB
id
e850e390-b32e-4382-a2c7-d480c41bd3a6
indications and usage exact
  1. 1 INDICATIONS AND USAGE DAURISMO is indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy. DAURISMO is a hedgehog pathway inhibitor indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy. ( 1 )
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Pfizer Laboratories Div Pfizer Inc
    matched search terms
    1. leukemia
    package ndcs
    1. 0069-0298-60
    2. 0069-1531-30
    product ndcs
    1. 0069-0298
    2. 0069-1531
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 2105850
      2. 2105856
      3. 2105858
      4. 2105860
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00700.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
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      skip
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      total
      830
      sha256
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      url
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      source url
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      spl effective date
      2025-12-12
      spl effective time
      20251212
      spl set id
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      spl version
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      substance names
      1. GLASDEGIB
      uniis
      1. K673DMO5H9
      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
        NDA210656
        payload
        all indexed label documents
        1. Appl No
          210656
          Application Docs Date
          2018-11-21 00:00:00
          Application Docs ID
          56533
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
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        2. Appl No
          210656
          Application Docs Date
          2020-03-20 00:00:00
          Application Docs ID
          62209
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        3. Appl No
          210656
          Application Docs Date
          2020-03-20 00:00:00
          Application Docs ID
          62210
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        4. Appl No
          210656
          Application Docs Date
          2023-03-28 00:00:00
          Application Docs ID
          73895
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
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        all submission records
        1. Appl No
          210656
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2018-11-21 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          210656
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2020-03-19 00:00:00
          Submission Type
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          Submissions Public Notes
        3. Appl No
          210656
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
          4
          Submission Status
          AP
          Submission Status Date
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          Submission Type
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          Submissions Public Notes
        4. Appl No
          210656
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5
          Submission Status
          AP
          Submission Status Date
          2023-03-27 00:00:00
          Submission Type
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          Submissions Public Notes
        application number
        NDA210656
        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
        2023-03-27
        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
          210656
          Application Docs Date
          2023-03-28 00:00:00
          Application Docs ID
          73895
          Application Docs Title
          0
          Application Docs Type ID
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          Submission No
          5
          Submission Type
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        official application record
        Appl No
        210656
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        PFIZER
        openfda application present
        true
        products
        1. Active Ingredient
          GLASDEGIB MALEATE
          Appl No
          210656
          Drug Name
          DAURISMO
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          EQ 25MG BASE
          marketing status
          1. Prescription
        2. Active Ingredient
          GLASDEGIB MALEATE
          Appl No
          210656
          Drug Name
          DAURISMO
          Form
          TABLET;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 100MG BASE
          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
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      brand names
      1. Daurismo
      classification reasons
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      clinical review status
      pending
      content role
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      context span
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      true
      exact text
      1 INDICATIONS AND USAGE DAURISMO is indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy. DAURISMO is a hedgehog pathway inhibitor indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old
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      qualifier mentions
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      3. context exact
        1 INDICATIONS AND USAGE DAURISMO is indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
        kind
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        true
        exact text
        in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old or who have comorbidities that p
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      regulatory links
        schema version
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          exact text
          1 INDICATIONS AND USAGE DAURISMO is indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
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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
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          Source null
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          Passage 2 · positive indication candidate
          application numbers
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          brand names
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          classification reasons
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          exact text
          cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy. DAURISMO is a hedgehog pathway inhibitor indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy. ( 1 )
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            DAURISMO is a hedgehog pathway inhibitor indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
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              exact text
              cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy. ( 1 )
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              ind-span-0e10f287cb7a79ad1724
              label id
              e850e390-b32e-4382-a2c7-d480c41bd3a6
              positive predicate support span
              Source null
              qualifier mentions
                regulatory links
                  schema version
                  0.1.0
                  source batch sha256
                  24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                  source defined aliases
                    source span
                    end
                    560
                    end exclusive
                    true
                    exact text
                    ( 1 )
                    label id
                    e850e390-b32e-4382-a2c7-d480c41bd3a6
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    8c27afa530f69d85ef5a7b590964de0218fb9343d469a2640f0134c3d0789d76
                    start
                    555
                    source url
                    https://api.fda.gov/drug/label.json?search=id%3A%22e850e390-b32e-4382-a2c7-d480c41bd3a6%22
                    spl effective date
                    2025-12-12
                    spl set id
                    204a6f7e-c9a4-472b-abd2-9527bda64d17
                    spl version
                    11
                    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

                    Preserved source evidence · Not medical advice