Komzifti (ziftomenib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

Citation

Kura Oncology, Inc. Komzifti (ziftomenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/220305s000lbl.pdf. Revised November 2025. Accessed December 23, 2025.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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 alterantive treatment options.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	NPM1 p.W288Cfs*12	Acute Myeloid Leukemia	Ziftomenib	FDA