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FDA Medication Tracker

← All approvals · Cancer · 2025

Komzifti (ziftomenib)

The FDA approved Komzifti (ziftomenib) on November 13, 2025 to treat adults with relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 mutation who have no satisfactory alternative treatment options.
Brand name
Komzifti
Generic name
ziftomenib
FDA approval date
November 13, 2025
Approved use (FDA wording)
To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 mutation who have no satisfactory alternative treatment options
Company
Kura
Application
NDA220305
Dosage form / route
CAPSULE · ORAL
Drug class (EPC)
Menin Inhibitor [EPC]
Boxed warning on label
Yes (see the FDA label)
Category on this site
Cancer

Indications and usage, from the FDA label

KOMZIFTI is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 ( NPM1 ) mutation who have no satisfactory alternative treatment options [see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.1 ), and Clinical Studies ( 14 )] . KOMZIFTI is a menin inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 ( NPM1 ) mutation who have no satisfactory alternative treatment options. ( 1 )

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.