Kura Oncology and Kyowa Kirin Announce FDA Approval of KOMZIFTI™ (ziftomenib), the First and Only Once-Daily Targeted Therapy for Adults with Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia

– NPM1 mutations, one of the most common genetic drivers of AML, are now actionable for patients – – Acute unmet need in R/R NPM1-mutated AML defined by historically poor outcomes and low survival rates at relapse – – FDA grants full approval of KOMZIFTI ahead of PDUFA target action date – – Approval is based on the KOMET-001 trial, in which KOMZIFTI demonstrated deep responses, a potentially best-in-class safety profile, once-daily administration, and ease of co-administration with common supportive medica ...