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 ...

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 ...

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) ...

Kura Oncology (KURA) and Kyowa Kirin announced the U.S. Food and Drug Administration has granted full approval of KOMZIFTI for adult patients with relapsed or refractory acute myeloid leukemia with a ...

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.

– 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 – – ...

– 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, ...

Ziftomenib is the first Menin inhibitor approved for relapsed or refractory mutant nucleophosmin 1 acute myeloid leukemia, showing promising efficacy in clinical trials. The phase 2 KOMET-001 trial ...

Kura Oncology (KURA) and Kyowa Kirin announced the Journal of Clinical Oncology published the full results from the pivotal KOMET-001 clinical trial evaluating ziftomenib, an investigational, ...