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KOMZIFTI™ (ziftomenib) Added to National Comprehensive Cancer Network® (NCCN) Guidelines for Acute Myeloid Leukemia (AML)
KOMZIFTI, the first and only once-daily FDA-approved menin inhibitor for R/R NPM1-mutated AML, is now commercially available in the United States SAN DIEGO
About this update from Kura Oncology, Inc.
[{"type":"text","content":"KOMZIFTI, the first and only once-daily FDA-approved menin inhibitor for R/R NPM1-mutated AML, is now commercially available in the United States\nSAN DIEGO and TOKYO, Nov. 25, 2025 (GLOBE NEWSWIRE) -- 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. “The addition of KOMZIFTI to the NCCN Guidelines® in Oncology underscores the potential impact of KOMZIFTI for patients with R/R NPM1-mutated AML and supports our commitment to ensuring that patients have access to this important treatment option,” said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. “NPM1-mutated disease carries a substantial risk of relapse and historically poor outcomes in the relapsed or refractory setting. We are pleased to have received inclusion in the NCCN guidelines so rapidly after FDA approval and are committed to making KOMZIFTI available to patients in the United States.” About KOMZIFTI™KOMZIFTI (ziftomenib) is an oral menin inhibitor approved for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. KOMZIFTI is in development for the front-line treatment of AML harboring NPM1 mutations, KMT2A translocations and FLT3 mutations, with the potential to be combined with approved therapies and...