Kura Oncology Gets FDA Breakthrough Therapy Designation For Ziftomenib In R/R NPM1-Mutant AML

(RTTNews) - Kura Oncology, Inc. (KURA) on Monday announced that it has been granted FDA Breakthrough Therapy Designation for its investigational drug, Ziftomenib, aimed at treating patients with relapsed/refractory or R/R NPM1-mutant acute myeloid leukemia also known as AML.

The company stated that the FDA awarded this designation after reviewing data from Kura's ongoing KOMET-001 clinical trial involving patients with R/R NPM1-mutant AML.

Additionally, the company confirmed that they are on track to complete the registration-directed trial of Ziftomenib in R/R NPM1-mutant AML by mid-2024.