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Kura Oncology and Kyowa Kirin Announce FDA Approval of KOMZIFTI™ (ziftomenib), the First and Only Once-Daily Targeted Therapy for Adults with Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia
– NPM1 mutations, one of the most common genetic drivers of AML, are now actionable for patients – – Acute unmet need in R/R NPM1-mutated AML defined by historically poor outcomes and low survival rates at relapse – – FDA grants full approval of KOMZIFTI ahead of PDUFA target action date – – Approval is based on the KOMET-001 trial, in which KOMZIFTI demonstrated deep responses, a potentially best-in-class safety profile, once-daily administration, and ease of co-administration with common suppo
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":"– NPM1 mutations, one of the most common genetic drivers of AML, are now actionable for patients –","length":98,"tagName":"p"},{"type":"text","content":"– Acute unmet need in R/R NPM1-mutated AML defined by historically poor outcomes and low survival rates at relapse –","length":116,"tagName":"p"},{"type":"text","content":"– FDA grants full approval of KOMZIFTI ahead of PDUFA target action date –","length":74,"tagName":"p"},{"type":"text","content":"– Approval is based on the KOMET-001 trial, in which KOMZIFTI demonstrated deep responses, a potentially best-in-class safety profile, once-daily administration, and ease of co-administration with common supportive medications in adult patients with R/R NPM1-mutated AML –","length":272,"tagName":"p"},{"type":"text","content":"– KOMZIFTI approval granted with no Boxed Warning related to QTc prolongation or Torsades de Pointes –","length":102,"tagName":"p"},{"type":"text","content":"– Kura Oncology will host a conference call on November 13, 2025, at 12:30 pm ET / 9:30 am PT –","length":100,"tagName":"p"},{"type":"text","content":"SAN DIEGO and TOYKO, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151) today announced the U.S. Food and Drug Administration (FDA) has granted full approval of KOMZIFTI™ (ziftomenib) for adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) 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 (NPM1-m) AML, a devastating blood cancer with limited treatment options.","length":582,"tagName":"p"},{"type":"text","content":"“KOMZIFTI combines compelling efficacy, a favorable safety profile, compatibility with concomitant medicat...