Kura Oncology, Kyowa Kirin announce FDA approval of KOMZIFTI for AML

Kura Oncology (KURA) and Kyowa Kirin announced the U.S. Food and Drug Administration has granted full approval of KOMZIFTI for adult patients with relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. KOMZIFTI is the first and only once-daily, oral menin inhibitor approved for R/R NPM1-mutated AML, a devastating blood cancer with limited treatment options. Approval is supported by the pivotal KOMET-001 trial, which evaluated KOMZIFTI’s safety and efficacy in 112 R/R NPM1-m AML patients. The rate of complete remission plus CR with partial hematologic recovery was 21.4%. The median duration of CR+CRh was 5.0 months and the median time to first response in patients who achieved a CR or CRh was 2.7 months. 88% of patients who achieved CR or CRh did so within 6 months of initiating KOMZIFTI. These data from the Prescribing Information are generally consistent with findings recently published in the Journal of Clinical Oncology.