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IDH1 R132 mutations turn a metabolic enzyme into a producer of the oncometabolite 2-HG. They define lower-grade gliomas and occur in acute myeloid leukaemia and bile duct cancer, each with an approved IDH1 inhibitor.
Codon 132 substitutions (R132H in over 90 percent of gliomas; R132C, G, S and L more often in AML and cholangiocarcinoma) are detected by IHC for R132H in glioma and by PCR or sequencing elsewhere. Ivosidenib (Tibsovo) is labelled for AML (newly diagnosed unfit, and relapsed or refractory), MDS and previously treated cholangiocarcinoma with a susceptible IDH1 mutation as detected by an FDA-approved test; olutasidenib (Rezlidhia) for relapsed or refractory AML with a susceptible IDH1 mutation; vorasidenib (Voranigo, 2024) for grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation after surgery. The Abbott RealTime IDH1 and Oncomine Dx Target Test are the listed companion diagnostics.
In plain words · A metabolic enzyme whose mutant form produces a molecule that scrambles how genes are read; blocking it slows brain tumours and leukaemias.
An IDH1 mutation opens a targeted tablet in three settings: ivosidenib or olutasidenib in acute myeloid leukaemia, ivosidenib in bile duct cancer after chemotherapy, and vorasidenib in a grade 2 glioma after surgery, where it can delay the need for radiotherapy and chemotherapy. In glioma the mutation also carries a better outlook than the same tumour without it.
Written only from the label or guideline text cited on this page. Not medical advice; your own report and the reading your team gives it come first.
A susceptible IDH1 codon 132 substitution (R132C, R132H, R132G, R132S, R132L) by PCR or sequencing of blood, marrow or tumour tissue; R132H can be screened by immunohistochemistry in glioma.
“R132 mutations (R132C, R132H, R132G, R132S, and R132L)”
FDA: List of FDA-Authorized Companion Diagnostic Devices| Threshold | Drug | Cancer | Regulator | Source |
|---|---|---|---|---|
| Susceptible IDH1 mutation | Ivosidenib | IDH1- and IDH2-mutated acute myeloid leukaemia | FDA | label |
| Susceptible IDH1 mutation | Olutasidenib | IDH1- and IDH2-mutated acute myeloid leukaemia | FDA | label |
| Susceptible IDH1 or IDH2 mutation, grade 2 glioma after surgery | Vorasidenib | Astrocytoma, IDH-mutant (grades 2 to 4) | FDA | label |
| Device | Maker | Indication and sample | Drug | PMA / 510(k) |
|---|---|---|---|---|
| Abbott RealTime IDH1 | Abbott Molecular | Acute Myeloid Leukemia - Peripheral Blood or Bone Marrow | Ivosidenib | P170041 (07/20/2018) |
| Abbott RealTime IDH1 | Abbott Molecular | Acute Myeloid Leukemia - Peripheral Blood or Bone Marrow | Olutasidenib | P170041/S006 (12/01/2022) |
| Oncomine Dx Target Test | Life Technologies (Thermo Fisher Scientific) | Cholangiocarcinoma - Tissue | Ivosidenib | P160045/S028 (08/25/2021) |
| Oncomine Dx Target Test | Life Technologies (Thermo Fisher Scientific) | Astrocytoma and Oligodendroglioma - Tissue | Vorasidenib | P160045/S046 (09/18/2024) |
Matched on the name and aliases of the readout in the title, setting and summary of each trial; a match is a mention, not proof the readout was an entry criterion.
Shares NPM1 mutation, Acute myeloid leukaemia and the tag biomarker.
Shares Olutasidenib, Vorasidenib, Ivosidenib, IDH1 / IDH2.
Shares NPM1 mutation, Acute myeloid leukaemia and the tag biomarker.
Shares Vorasidenib, IDH1 / IDH2, Glioma & glioblastoma and the tag idh.
Shares Oncomine Dx Target Test, Next-generation sequencing (NGS) and the tag biomarker.
Shares Oncomine Dx Target Test, Next-generation sequencing (NGS) and the tag biomarker.
Shares Oncomine Dx Target Test, Next-generation sequencing (NGS) and the tag biomarker.
Shares 1p/19q codeletion, Vorasidenib, Oligodendroglioma, IDH-mutant and 1p/19q-codeleted, Astrocytoma, IDH-mutant (grades 2 to 4).