India, June 1 -- Kura Oncology Inc. (KURA) and Kyowa Kirin Co., Ltd. announced the U.S. Food and Drug Administration has accepted Kuras New Drug Application or NDA seeking full approval for ziftomenib as a treatment for adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a nucleophosmin 1 (NPM1) 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 company noted that the NDA is based on results from the Phase 2 KOMET-001 registrational trial in R/R NPM1-mutant (NPM1-m) AML. The KOMET-001 trial achieved its primary endpoint of complete remission plus CR with partial hematological recovery and the primary en...