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DISEASE & TREATMENT SETTING

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

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

Exact scope

1.1 Newly Diagnosed Acute Myeloid Leukemia TIBSOVO is indicated in combination with azacitidine or as monotherapy for the treatment of newly diagnosed acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy [see Dosage and Administration (2.1) , Clinical Pharmacology (12.1) and Clinical Studies (14.1) ].

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
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
    1.1 Newly Diagnosed Acute Myeloid Leukemia TIBSOVO is indicated in combination with azacitidine or as monotherapy for the treatment of newly diagnosed acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy [see Dosage and Administration (2.1) , Clinical Pharmacology (12.1) and Clinical Studies (14.1) ].

    Study evidence for this setting

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

    Source relationships and population-mapping limitations
    bindings
      mappings

        Download this complete draft source relationship record →

        Preserved source evidence · Not medical advice