Initial US Approval:
2025
Key Clinical Studies:
KO-MEN-001 (NCT04067336)
Drug Class/Description:
Menin inhibitor
WARNING: DIFFERENTIATION SYNDROME
See full prescribing information for complete boxed warning.
Differentiation syndrome, which can be fatal, has occurred with KOMZIFTI. If differentiation syndrome is suspected, interrupt KOMZIFTI and initiate oral or intravenous corticosteroids with hemodynamic and laboratory monitoring until symptom resolution; resume KOMZIFTI upon symptom improvement.
Indications and Usage:
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.
Dosage and Administration:
- Select patients for treatment with KOMZIFTI based on the presence of an NPM1 mutation.
- Recommended dosage: 600 mg orally once daily until disease progression or unacceptable toxicity. For patients without confirmed disease progression or unacceptable toxicity, treat for a minimum of 6 months to allow time for a clinical response.
- See Full Prescribing Information for administration instructions and dosage modifications.
Dosage Forms and Strengths:
Capsules: 200 mg
Contraindications:
None.
Warnings and Precautions:
QTc Interval Prolongation: Monitor electrocardiograms and electrolytes. Correct hypokalemia and hypomagnesemia prior to treatment. Interrupt KOMZIFTI if the QTc interval is > 500 ms.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception.
Adverse Reactions:
The most common adverse reactions (≥20%) are infection without an identified pathogen, hemorrhage, diarrhea, nausea, fatigue, edema, bacterial infection, musculoskeletal pain, differentiation syndrome, pruritus, febrile neutropenia, and transaminases increased.
The most common laboratory abnormalities (≥10%) are aspartate aminotransferase increased, potassium decreased, albumin decreased, alanine aminotransferase increased, sodium decreased, creatinine increased, alkaline phosphatase increased, bilirubin increased, potassium increased.
Drug Interactions:
Strong or Moderate CYP3A4 Inhibitors: Monitor more frequently for adverse reactions.
Strong or Moderate CYP3A4 Inducers: Avoid concomitant use.
Proton Pump Inhibitors: Avoid concomitant use.
H2 Receptor Antagonists and Antacids: Avoid concomitant use. If concomitant use cannot be avoided, modify KOMZIFTI administration time.
Drugs that Prolong the QTc Interval: Avoid concomitant use. If concomitant use is unavoidable, monitor patients more frequently for QTc interval prolongations.
Use in Specific Populations:
Lactation: Advise not to breastfeed.
Adapted From:
https://kuraoncology.com/wp-content/uploads/prescribinginformation.pdf
Every health-care provider should make their own determination regarding specific safe and appropriate patient care practices, including drug dosages and indications. The provider should always consult the most recent prescribing/product information. FDA Focus information is not guaranteed to be accurate, complete, or current. JADPRO and its editors, authors, reviewers, and commentators cannot be held responsible for any liability incurred as a consequence of the application of any of the information listed within.
