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DISEASE & TREATMENT SETTING

TIBSOVO: acute myeloid leukemia with IDH1 stated without a specific alteration, IDH1 mutation

Source-derived catalogue. This is not a treatment recommendation or a personalised trial match.

Exact scope

1 INDICATIONS AND USAGE TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with: Newly Diagnosed Acute Myeloid Leukemia (AML) In combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy ( 1.1 ).

Broader topic: Acute Myeloid Leukemia

Source population
Not part of this definition
Disease extent
Not part of this definition
Treatment line
Not part of this definition
Stage
Not part of this definition
Resectability
Not part of this definition
Biomarkers, prior therapy and derivation
molecular
  1. gene
    IDH1
    alteration
    stated without a specific alteration
    status
    present
  2. gene
    IDH1
    alteration
    mutation
    status
    present
prior therapy
    derivation status
    source-attested
    derivation note
    Scoped from the FDA approved indication for TIBSOVO (product label). Only dimensions stated in that wording are part of this definition.
    source wording
    1 INDICATIONS AND USAGE TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with: Newly Diagnosed Acute Myeloid Leukemia (AML) In combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy ( 1.1 ).

    Study evidence for this setting

    2 linked studies · Applicability is a draft source assessment, not a determination of your eligibility.

    NCT02719574 · Source cited / selected · Scope: unclear

    Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation

    6 outcome links · 13 safety-group records · 0 quality-of-life measures

    →

    NCT03173248 · Source cited / selected · Scope: unclear

    Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation

    6 outcome links · 2 safety-group records · 2 quality-of-life measures

    →
    Source relationships and population-mapping limitations
    bindings
      mappings

        Download this complete draft source relationship record →

        Preserved source evidence · Not medical advice