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Acute Myeloid Leukemia (AML)

HemeIndication · Leukemia

Acute Myeloid Leukemia is an aggressive hematologic cancer marked by uncontrolled proliferation of myeloid precursor cells. Diagnosis relies on genetic and molecular features.

Approvals
6
Therapies
6
Biomarkers
3
Mapped tests
3

Biomarkers used in this indication

Each approval combines this indication with specific biomarker criteria and a therapy. Select a therapy from the tables below to open its FDA-defined testing pathway.

Indication-specific biomarkers

Defined explicitly for Acute Myeloid Leukemia (AML) in FDA labeling.

BiomarkerBiomarker criteriaTherapies
FLT3 (ITD/TKD)
  • ITD mutations and TKD mutations D835 and I836
IDH1
  • R132 mutations (R132C, R132H, R132G, R132S, and R132L)
IDH2
  • R140Q, R140L, R140G, R140W, R172K, R172M, R172G, R172S, and R172W
Tumor-agnostic biomarkers

Defined at the solid tumor level and applicable to Acute Myeloid Leukemia (AML) and other solid tumor cancers.

No tumor-agnostic biomarker approvals are currently mapped for this indication.

Therapies with biomarker-defined approvals

Each therapy below has at least one FDA companion diagnostic approval tied to Acute Myeloid Leukemia (AML). Select a therapy to view the specific approval and eligible tests.

Therapy
IDHIFA
enasidenib · Bristol Myers Squibb, Servier Pharmaceuticals

IDH2 (R140Q, R140L, R140G, R140W, R172K, R172M, R172G, R172S, and R172W)

Therapy
REZLIDHIA
olutasidenib · Rigel Pharmaceuticals

IDH1 (R132 mutations (R132C, R132H, R132G, R132S, and R132L))

Therapy
RYDAPT
midostaurin · Novartis

FLT3 (ITD/TKD) (ITD mutations and TKD mutations D835 and I836)

Therapy
TIBSOVO
ivosidenib · Servier Pharmaceuticals

IDH1 (R132 mutations (R132C, R132H, R132G, R132S, and R132L))

Therapy
VANFLYTA
quizartinib · Daiichi Sankyo

FLT3 (ITD/TKD) (ITD mutations and TKD mutations D835 and I836)

Therapy
XOSPATA
gilterinib · Astellas Pharma

FLT3 (ITD/TKD) (ITD mutations and TKD mutations D835 and I836)

This indication view is scoped to Acute Myeloid Leukemia (AML). You can also explore how it appears alongside other cancers in Know Your Companions™ by searching or filtering on the main map.