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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 StatesSAN 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 mutati
About this update from Kyowa Kirin Co., Ltd.
[{"type":"image","alt":"Kura Oncology, Inc.","displaySize":"","headline":null,"caption":"Kura Oncology, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":157,"url":"https://media.zenfs.com/en/globenewswire.com/8e159ab705e63b696053c85c0d94912a"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/IOFGB7AyVbH8Ah1e0o_Gjg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTIyMDtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/8e159ab705e63b696053c85c0d94912a","width":300,"height":157}},"lazy":false},{"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","length":145,"tagName":"p"},{"type":"text","content":"SAN 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.","length":595,"tagName":"p"},{"type":"text","content":"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.","length":559,"tagName":"p"},{"type":"text","content":"“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...