Two phase 3 trials will study Kura Oncology’s ziftomenib for frontline acute myeloid leukemia, one with venetoclax and the ...

SAN DIEGO and TOKYO, Sept. 25, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced the Journal of Clinical Oncology ...

Kyowa Kirin’s big bet on Kura Oncology has paid off in short order, delivering an FDA approval for a medicine to treat a ...

– Encouraging clinical activity with deep responses demonstrated in the KOMET-007 trial with the combination of 600 mg ziftomenib with 7+3 in newly diagnosed patients with NPM1-m and KMT2A-r AML – – ...

The approval was based on data from the single-arm, open-label phase 2 KOMET-001 trial, which evaluated ziftomenib, a menin inhibitor, in adults with R/R AML with an NPM1 mutation.

FDA has approved Komzifti (ziftomenib) as the first once-daily, oral menin inhibitor for adults with relapsed or refractory NPM1-mutated AML, supported by Phase II KOMET-001 data showing meaningful ...

Using chronological age cut-offs—such as 60 years—to divide patients with acute myeloid leukemia (AML) for clinical trials ...

Kura Oncology and Kyowa Kirin announced that clinical data from the KOMET-007 trial, evaluating ziftomenib in combination with the standard chemotherapy regimen of cytarabine and daunorubicin (7+3) ...

The FDA has granted full approval to Kura Oncology and Kyowa Kirin’s Komzifti (ziftomenib), marking the first FDA-approved once-daily, oral menin inhibitor for adults with relapsed or refractory (R/R) ...

– New Drug Application for ziftomenib in adults with R/R NPM1-m AML remains under FDA Priority Review, with a PDUFA target action date of November 30, 2025 – – KOMET 017 Phase 3 trials to evaluate ...

– KOMET-001 in R/R NPM1-m AML met its primary endpoint with ziftomenib monotherapy demonstrating significant clinical benefit and deep responses – – Consistent activity across pre-specified subgroups, ...