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
- 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
Source relationships and population-mapping limitations
- bindings
- mappings
Download this complete draft source relationship record →
Preserved source evidence · Not medical advice
Triangle