Kura Oncology(US:KURA) Globenewswire·2025-11-25 22:16Core Insights - KOMZIFTI (ziftomenib) is the first and only once-daily oral menin inhibitor approved by the FDA for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation, now commercially available in the U.S. [1][2] - The drug has been included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines as a Category 2A recommended treatment option for this patient population [1][3] Company Overview - Kura Oncology, Inc. is a biopharmaceutical company focused on precision medicines for cancer treatment, with KOMZIFTI being a key product in its pipeline [19] - Kyowa Kirin Co., Ltd. is a global specialty pharmaceutical company with a long history in drug discovery and biotechnology innovation, collaborating with Kura on the commercialization of KOMZIFTI [20] Clinical Data - KOMZIFTI received full FDA approval on November 13, 2025, based on the KOMET-001 clinical trial, which demonstrated a 21.4% complete response (CR) or complete response with partial hematologic recovery (CRh) rate and a median duration of response of 5 months [2] - The clinical trial involved 112 patients with R/R AML and NPM1 mutation, with differentiation syndrome (DS) occurring in 26% of patients [8][14] Treatment Guidelines - The inclusion of KOMZIFTI in the NCCN Guidelines highlights its potential impact on patients with R/R NPM1-mutated AML and reflects the commitment to patient access [3] - KOMZIFTI is also being developed for front-line treatment of AML with various mutations, indicating its potential to benefit a broader patient population [5] Safety Information - KOMZIFTI has a boxed warning for differentiation syndrome, which can be fatal, and requires monitoring and management protocols [6][7] - Adverse reactions reported in clinical trials include serious reactions in 79% of patients, with the most common being infections and differentiation syndrome [14][16]