Breakthrough Therapy Designation Granted for Ziftomenib in R/R NPM1-Mutant AML

Mollie Leoni, MD, Executive Vice President of Clinical Development, speaks to the significance of ziftomenib receiving FDA Breakthrough Therapy Designation for relapsed/refractory NPM1-mutant acute myeloid leukemia (AML).

This designation allows for frequent, expedited coordination with the FDA as Kura works to bring this potential treatment to patients. The FDA’s decision to grant Breakthrough Therapy Designation to ziftomenib reflects the agency’s recognition that ziftomenib may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies for NPM1-mutant AML.