FDA Reviews Kura's NDA For Ziftomenib To Treat Acute Myeloid Leukemia With NPM1 Mutation

(RTTNews) - 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 endpoint was statistically significant. Ziftomenib was well tolerated with limited myelosuppression and 3% ziftomenib-related discontinuations. The safety and tolerability of ziftomenib were consistent with previous reports, and the benefit-risk profile for ziftomenib is highly encouraging.

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