Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that NPM1 p.W288Cfs*12 status confers therapeutic sensitivity to Ziftomenib in patients with Acute Myeloid Leukemia.

This statement is based on a regulatory approval from the Food and Drug Administration:

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.

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.