Kura Oncology and Kyowa Kirin Report Positive Pivotal Ziftomenib Monotherapy Data at 2025 ASCO ...

Kura Oncology Drug’s Data at ASCO Support FDA Filing Now Under Priority Review for Leukemia

Kura Oncology’s ziftomenib addresses a specific genetic mutation present in about 30% of cases of acute myeloid leukemia. Data from the drug’s pivotal Phase 2 test were presented during the annual meeting of the American Society of Clinical Oncology. The post Kura Oncology Drug’s Data at ASCO Support FDA Filing Now Under Priority Review for Leukemia appeared first on MedCity News.

Kura Oncology and Kyowa Kirin Announce FDA Acceptance of New Drug ...

Kura Oncology and Kyowa Kirin Report Positive Pivotal Ziftomenib Monotherapy Data at 2025 ASCO ...

– CR/CRh rate of 23% in pivotal Ph 2 cohort of R/R NPM1 -m AML patients –

Ziftomenib Earns FDA Priority Review for R/R NPM1-Mutrant AML

The FDA assigned a Prescription Drug User Fee Act date of November 30, 2025, for ziftomenib in NPM1-mutant acute myeloid leukemia.

FDA Grants Priority Review to NDA of Ziftomenib in NPM1-Mutant AML

If approved, ziftomenib could be the first FDA-approved Menin inhibitor for relapsed/refractory acute myeloid leukemia with an NPM1 mutation.

ASCO25: Kura’s Phase II ziftomenib results trigger NDA acceptance from FDA

The FDA set a PDUFA date in late 2025 as ziftomenib led to significant disease response in patients with common subtype of AML.The post ASCO25: Kura’s Phase II ziftomenib results trigger NDA acceptance from FDA appeared first on Clinical Trials Arena.