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Kura Oncology Announce FDA Approval of KOMZIFTI™ (ziftomenib), the First and Only Once-Daily Targeted Therapy for Adults with Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia
_↗ ir.kuraoncology.com
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The U.S. Food and Drug Administration (FDA) has granted full approval to KOMZIFTI (ziftomenib), an oral menin inhibitor developed by Kura Oncology, Inc. and Kyowa Kirin Co., Ltd., for adult patients suffering from relapsed or refractory (R/R) acute myeloid leukemia (AML) that harbors a susceptible NPM1 mutation, addressing an acute unmet need defined by historically poor outcomes and low survival rates upon relapse.

KOMZIFTI is now the first and only once-daily, oral menin inhibitor approved for this specific population, targeting one of the most common genetic drivers of AML, which occurs in approximately 30% of cases.

The approval, granted ahead of the PDUFA target date, is supported by the pivotal KOMET-001 trial, which demonstrated compelling efficacy with a rate of complete remission (CR) plus CR with partial hematologic recovery (CRh) of 21.4%, and a median duration of CR+CRh of 5.0 months, with 88% of these responses occurring within six months. Crucially, KOMZIFTI demonstrated a favorable, potentially best-in-class safety profile, a significant advantage for this often older and vulnerable patient population who may be unable to tolerate intensive chemotherapy.

Specifically, the drug was approved without a Boxed Warning related to QTc prolongation or Torsades de Pointes, and it exhibits an absence of clinically meaningful drug-drug interactions, which simplifies its co-administration with other common supportive medications. While it does carry a Boxed Warning for differentiation syndrome, a known risk for drugs that induce cell differentiation, its overall manageable safety profile and convenient oral administration make it a vital new treatment option. Kura Oncology and Kyowa Kirin, who entered into a global strategic collaboration to develop and commercialize the drug, are fully prepared for the launch, with Kura leading the U.S. strategy and manufacturing, and Kyowa Kirin leading development and commercialization outside the U.S. The companies are also committed to exploring KOMZIFTI's potential in combination regimens and earlier lines of AML therapy.

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