Regulatory approval

Published by the Food and Drug Administration. Approved

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.

This is written in the approval document.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	NPM1 p.W288Cfs*12	Acute Myeloid Leukemia	Ziftomenib

Contributions

Date	Contributor	Description
2025-12-23	Van Allen lab	On 2025-11-13, the US FDA granted regular approval to ziftomenib for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with susceptible NPM1 mutation who have no satisfactory alternative treatment options.
2025-11-13	Food and Drug Administration	Indication received traditional approval.