Regulatory milestones approvals, filings & regulatory actions · 2 recorded
Milestone
Jurisdiction
Brand
Indication
Date
Sentence it was read from
Filedacute myeloid leukemia with NPM1-MLF1 fusion1 milestone
Filed
US (FDA)
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acute myeloid leukemia with NPM1-MLF1 fusion
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“in the second quarter of 2025, the companies announced submission of an NDA for ziftomenib for the treatment of adult patients with R/R NPM1 -m AML.” kuraoncology.com ↗
“the companies announced submission of an NDA for ziftomenib for the treatment of adult patients with R/R NPM1 -m AML in the first quarter of 2025.” kuraoncology.com ↗
Findings demonstrate differentiated menin binding and activity against certain resistance-associated mutations, further supporting ziftomenib’s potential across genetically defined acute leukemias
The publication reports nearly two-thirds of patients experienced clinically meaningful, deep and durable responses with a well-tolerated safety profile in adults with R/R NPM1-m AML.
The publication reports nearly two-thirds of patients experienced clinically meaningful, deep and durable responses with a well-tolerated safety profile in adults with R/R NPM1 -m AML.
today announced positive topline results from KOMET-001, the Phase 2 registration-directed trial of ziftomenib, a highly selective, once-daily, oral investigational menin inhibitor, in patients with relapsed/refractory (R/R) NPM1-mutant (NPM1-m) acute myeloid leukemia (AML).
The paper, entitled “Ziftomenib in relapsed/refractory acute myeloid leukaemia (KOMET-001): results from an open-label, multi-cohort, phase 1a/1b trial,” is now available on The Lancet Oncology website and in the Scientific Manuscripts section on Kura’s website.
Earlier today, Kura announced FDA clearance of its IND application for ziftomenib for the treatment of advanced gastrointestinal stromal tumors (GIST) in combination with imatinib.
today announced clearance by the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for ziftomenib, the Company’s potent and selective menin inhibitor, for the treatment of advanced gastrointestinal stromal tumors (GIST).
Ziftomenib demonstrated meaningful levels of glycemic control in preclinical in vivo models, including reduced fasting blood glucose levels and %HbA1C within 27 days as well as consistent improvement in both insulin sensitivity and insulin production.
today announced that its investigational drug, ziftomenib, has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of patients with relapsed/refractory (R/R) NPM1-mutant acute myeloid leukemia (AML).
No differentiation syndrome events of any grade were reported, and no dose-limiting toxicities, evidence of QTc prolongation, drug-drug interactions or additive myelosuppression were observed.