Last reviewed · How we verify

Acute myeloid leukemia with FMS-like tyrosine kinase-3 mutation — Treatment Landscape & Competitive Intelligence

Acute myeloid leukemia with FMS-like tyrosine kinase-3 mutation (disease) competitive landscape: 1 marketed treatments tracked, 0 Phase 3 candidates, 0 Phase 2 candidates. Recent regulatory actions and upcoming PDUFA dates across the entire treatment set.

1 marketed 0 Phase 3 0 Phase 2 Live · 30-min refresh

Marketed treatment landscape

Approved drugs treating Acute myeloid leukemia with FMS-like tyrosine kinase-3 mutation, deduplicated by molecule. See the full disease page for line-of-therapy detail.

DrugGenericSponsorClassTargetLine of therapyFirst approval
Vanflyta QUIZARTINIB Daiichi Sankyo Inc Macrophage colony-stimulating factor 1 receptor 2023-01-01

Phase 3 pipeline

No Phase 3 pipeline candidates tracked.

Phase 2 pipeline

No Phase 2 pipeline candidates tracked.

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this treatment set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this treatment set.

Sponsor landscape

  1. Daiichi Sankyo Inc · 1 drug in Acute myeloid leukemia with FMS-like tyrosine kinase-3 mutation

Subscribe to ongoing alerts

Every new regulatory action, PDUFA date, or trial completion in Acute myeloid leukemia with FMS-like tyrosine kinase-3 mutation:

Cite this brief

Drug Landscape (2026). Acute myeloid leukemia with FMS-like tyrosine kinase-3 mutation — Treatment Landscape & Competitive Intelligence Brief. https://druglandscape.com/ci/disease/acute-myeloid-leukemia-with-fms-like-tyrosine-kinase-3-mutation. Accessed 2026-06-10.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing