North America
Kura Oncology and Kyowa Kirin Announce FDA Approval of KOMZIFTITM (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 supportive medications in adult patients with R/R NPM1-mutated AML –
– KOMZIFTI approval granted with no Boxed Warning related to QTc prolongation or Torsades de Pointes –
– Kura Oncology will host a conference call on November 13, 2025, at 12:30 pm ET / 9:30 am PT –
SAN DIEGO and TOKYO, November 13, 2025 – Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151) today anno
13 November 2025
