Kura Oncology, Kyowa Kirin announces FDA accepted NDA for ziftomenib

Kura Oncology (KURA) and Kyowa Kirin announced the U.S. Food and Drug Administration, FDA, has accepted Kura’s New Drug Application, NDA, seeking full approval for ziftomenib as a treatment for adult patients with relapsed or refractory (R/R) acute myeloid leukemia with a nucleophosmin 1 mutation. The application has been granted Priority Review and assigned a Prescription Drug User Fee Act, PDUFA, target action date of November 30, 2025. “The FDA’s acceptance of our New Drug Application marks a significant milestone for Kura and Kyowa Kirin and, more importantly, for patients living with this genetic subset of AML, who face an aggressive form of the disease with few treatment options,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “This achievement reflects the strength of the clinical data for ziftomenib as well as the incredible commitment of our teams. Along with our partners at Kyowa Kirin, we look forward to continuing to work closely with the FDA throughout the review process and to prepare for the anticipated launch of this treatment, which holds potential to meaningfully impact the lives of patients and their families.”