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

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

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 ...

– 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.

Final 5-year data from the phase 2 2102-HEM-101 trial (NCT02719574) show that olutasidenib (Rezlidhia) delivered sustained ...

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 ...

– 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 ...

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) ...

– 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, ...