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Stock impact report

Kura and Kyowa Kirin secure FDA go-ahead for targeted leukaemia therapy [Yahoo! Finance]

Kura Oncology, Inc. (KURA) 
Last kura oncology, inc. earnings: 2/25 04:03 pm Check Earnings Report
US:NASDAQ Investor Relations: ir.kuraoncology.com/investor-relations
Company Research Source: Yahoo! Finance
Following the US Food and Drug Administration's (FDA) call to greenlight the drug, Komzifti will now be available to adult patients with relapsed or refractory acute myeloid leukaemia (r/r AML). The targeted therapy is specifically indicated for patients with a susceptible Nucleophosmin 1 (NPM1) mutation. Komzifti obtained the approval based on the results of the Phase III KOMET-001 study (NCT04067336), which saw the drug trigger complete remission (CR) plus CR with partial haematological recovery (CRh) in 21.4% of patients. This effect was sustained over a median duration of five months. As Komzifti enters the market, it becomes the first once-daily oral menin inhibitor to gain FDA approval in NPM1-mutated r/r AML – an indication with limited treatment options that is commonly associated with poor patient prognoses. It is currently estimated that just under one-third of AML cases present a NPM1 founder mutation. Within this patient population, around 70% of patients will rel Show less Read more
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