Komzifti

Adults with R/R AML with a susceptible NPM1 mutation who have no satisfactory alternative treatment options.

200 mg orally once daily with food.

Capsules: 100 mg, 200 mg

None listed in the prescribing information.

• Differentiation Syndrome: Can be fatal. Monitor and treat promptly.
• QTc Prolongation: Monitor ECGs.
• Hepatotoxicity: Monitor liver function.
• Embryo-Fetal Toxicity: Can cause fetal harm.

Nausea (42%), Diarrhea (36%), QTc Prolongation (28%), Musculoskeletal Pain (26%), Fatigue (24%), Increased ALT (22%), Febrile Neutropenia (20%), Differentiation Syndrome (18%)

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

QTc Prolonging Drugs: Avoid where feasible.
Strong CYP3A4 Inhibitors/Inducers: Avoid.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Ziftomenib selectively inhibits the menin-MLL1 protein-protein interaction. In NPM1-mutant AML, this complex drives aberrant HOXA/MEIS1 gene expression essential for leukemic survival.

Tmax: 2-4 hours. Protein binding: >99%. Half-life: ~14 hours. Steady state ~3 days.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• KOMET-001 — Ziftomenib in NPM1-mutant R/R AML. Phase I/II, n=63.
  🔬 NCT04067336 ↗

Komzifti has FDA-approved indications across the following cancer types covered on CancerDrugEvidence: