Kura Oncology and Kyowa Kirin plan to pursue US Food and Drug Administration approval based on positive Phase II topline results for ziftomenib in relapsed/refractory NPM1-mutant acute myeloid leukemia (AML), but there are still questions that remain as to how they can differentiate it from other menin inhibitors like Syndax Pharmaceuticals’ first-in-class Revuforj (revumenib), which recently hit the market.
Kura/Kyowa Kirin’s Ziftomenib Scores In NPM1m AML, But Differentiation Is Key
The company plans to file for accelerated approval with the US FDA next quarter, but there are concerns about how differentiated ziftomenib would be from Syndax’s first in class menin inhibitor.
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