Onco-Summaries: Daily Oncology Updates at a Glance

13/11/2025

Kura Oncology and Kyowa Kirin's ziftomenib received FDA approval for certain R/R AML pts (Ref)

The US FDA granted full approval to Kura Oncology and Kyowa Kirin's ziftomenib (KOMZIFTI™; menin inhibitor) for adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. 

• Troy Wilson, President and CEO, Kura Oncology: “KOMZIFTI combines compelling efficacy, a favorable safety profile, compatibility with concomitant medications, and convenient once-daily oral administration in a population with few effective treatment options. These features highlight KOMZIFTI’s potential to serve as the menin inhibitor of choice in its approved indication. Together with our partner, Kyowa Kirin, we remain committed to advancing development of KOMZIFTI across the treatment continuum for AML, where its best-in-class profile offers potential for even greater impact in combination regimens and earlier lines of therapy. We are fully prepared to launch KOMZIFTI today and deliver this new medicine to patients in need.”

• The approval has been granted based on results from the Ph1/2 KOMET-001 trial

• In Nov'24, Kura Oncology and Kyowa Kirin entered into a global strategic collaboration to develop and commercialize KOMZIFTI