The FDA has approved a Kura Oncology drug developed for cases of acute myeloid leukemia (AML) carrying a certain genetic signature, giving the biotech its first commercial asset and the opportunity to challenge a Syndax Pharmaceuticals product that was first to the market in this class of targeted cancer therapies.

This emerging drug class treats leukemias characterized by a mutation to the NPM1 gene. The Thursday regulatory decision for Kura’s drug, ziftomenib, covers the treatment of adults whose relapsed or refractory AML carries this signature and has no treatment alternatives. San Diego-based Kura, which is partnered with Kyowa Kirin, will commercialize its new once-daily pill under the brand name Komzifti.

AML is a cancer of myeloid cells, white blood cells that typically develop

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