FDA Approves Kura Oncology’s KOMZIFTI for Relapsed or Refractory NPM1-Mutated AML
Kura Oncology Inc. has received FDA approval for KOMZIFTI™ (ziftomenib), an oral menin inhibitor, for treating adults with relapsed or refractory acute myeloid leukemia (AML) with an NPM1 mutation. This marks KOMZIFTI as the first FDA-approved menin inhibitor for this indication, supported by the KOMET-001 clinical trial. It is now included in the NCCN Clinical Practice Guidelines as a Category 2A treatment option.
Kura Oncology Inc. has received full approval from the U.S. Food and Drug Administration for KOMZIFTI™ (ziftomenib), an oral menin inhibitor, for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. This approval was supported by data from the KOMET-001 clinical trial and marks KOMZIFTI as the first and only once-daily FDA-approved menin inhibitor for this indication. The therapy has also been added to the National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology as a Category 2A recommended treatment option. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Kura Oncology Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9592458-en) on November 25, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)
