Kura Oncology And Kyowa Kirin Announce NCCN Inclusion Of Newly FDA-Approved KOMZIFTI As Recommended Treatment For Relapsed/Refractory AML With NPM1 Mutation

Kura Oncology, Inc. (NASDAQ:KURA, "Kura"))) and Kyowa Kirin Co., Ltd. (TSE: 4151, "Kyowa Kirin") today announced KOMZIFTI™ (ziftomenib), the first and only once-daily oral menin inhibitor to be approved for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation, has been included in the National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a Category 2A recommended treatment option for adults with relapsed/refractory AML with NPM1 mutation.

KOMZIFTI received full approval by the U.S. Food and Drug Administration on November 13, 2025, for the treatment of adults with relapsed or refractory AML with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. The approval was supported by data from the KOMET-001 clinical trial, including a 21.4% CR/CRh rate and median duration of CR/CRh response of 5 months.1,2 KOMZIFTI is now commercially available to prescribers in the U.S. and is available for purchase from a limited network of specialty pharmacies and distributors.