FDA Approves Komzifti for NPM1-Mutated Relapsed or Refractory AML; KOMET-001 CR/CRh Rate 21.4%
Kura Oncology and Kyowa Kirin announced on November 13 that the U.S. Food and Drug Administration (FDA) has granted full approval of Komzifti (ziftomenib) for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. It is the first and only once-daily oral menin inhibitor approved for this population.
The approval is supported by the pivotal KOMET-001 trial, which enrolled 112 patients with relapsed or refractory NPM1-mutated AML. The rate of complete remission (CR) plus CR with partial hematologic recovery (CRh) was 21.4% (95% CI: 14.2, 30.2), and the median duration of CR/CRh response was 5 months. The companies said the approval carries no boxed warning related to QTc prolongation or Torsades de Pointes.
Komzifti is now commercially available in the United States through a limited network of specialty pharmacies and distributors. The supporting data were previously published in the Journal of Clinical Oncology.
Source: Kura Oncology and Kyowa Kirin
Published by GSM · USA (original Chinese edition)
Photo: 图中是美国食品药品管理局（FDA）位于马里兰州银泉市白橡树园区的62号楼外景。来源：Wikimedia Commons, Public domain, The U.S. Food and Drug Administration。
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