Kura Oncology stock flat despite FDA approval of KOMZIFTI for AML
Investing.com -- Kura Oncology (NASDAQ:KURA) stock traded flat Thursday despite the U.S. Food and Drug Administration granting full approval for KOMZIFTI (ziftomenib) ahead of its scheduled PDUFA date.
The FDA approved KOMZIFTI for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. The approval makes KOMZIFTI the first and only once-daily, oral menin inhibitor approved for this indication.
The approval is based on results from the KOMET-001 trial, which demonstrated a complete remission plus complete remission with partial hematologic recovery rate of 21.4% in 112 patients with R/R NPM1-mutated AML. The median duration of response was 5.0 months.
Notably, KOMZIFTI’s approval came with a Boxed Warning for differentiation syndrome but without a Boxed Warning for QTc prolongation or Torsades de Pointes, potentially differentiating it from competing therapies.
"No real surprise on black box warning, DS black box expected on the menin inhibitor class. Recall Revuforj QTc prolongation black box warning was assigned on a single case of Torsades de Pointes, and not observed in ziftomenib data," wrote Mizuho analyst Salim Syed.
NPM1 mutations occur in approximately 30% of AML cases, with about 20% of these patients not responding to front-line therapy. Of those who do respond, 70% relapse within three years, highlighting the significant unmet need that KOMZIFTI aims to address.
The drug was developed through a global strategic collaboration between Kura Oncology and Kyowa Kirin Co., Ltd. (TSE:4151). Under the partnership, Kura leads development, regulatory, and commercial strategy in the U.S., while Kyowa Kirin manages these functions outside the U.S.
Kura has established a support program called Kura RxKonnect to help patients access the newly approved therapy.
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