Kura Oncology announces FDA full approval of KOMZIFTI for NPM1-mutated AML

Kura Oncology, Inc.

FDA granted full approval of KOMZIFTI (ziftomenib) on November 13, 2025 for R/R NPM1-mutated AML patients with no satisfactory alternative.
KOMZIFTI is the first and only once-daily oral menin inhibitor approved for this indication, with a CR+CRh rate of 21.4% in the KOMET-001 trial.
Median duration of CR+CRh was 5.0 months; median time to first response was 2.7 months; 88% of responders achieved remission within 6 months.
Kura Oncology set a wholesale acquisition cost of $48,500 per month; global collaboration with Kyowa Kirin oversees U.S. and ex-U.S. commercialization.
Boxed Warning for differentiation syndrome included; no Grade 4 or 5 QTc prolongation reported in the pivotal study.

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