Kura Oncology (KURA) said Tuesday it submitted a new drug application to the US Food and Drug Administration for ziftomenib to potentially treat adults with relapsed or refractory acute myeloid leukemia with an NPM1 mutation.
The biotechnology company said the FDA has 60 days to determine if the NDA is complete and accepted for review. Kura has requested priority review, which, if granted, would set a six-month review timeline after acceptance, the company said.
Kura said ziftomenib has received breakthrough therapy, fast track and orphan drug designations.
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