Home / Health / FDA Approves Rare Leukemia Pill Komzifti, Faces Boxed Warning
FDA Approves Rare Leukemia Pill Komzifti, Faces Boxed Warning
14 Nov
Summary
- FDA approves Kura Oncology's Komzifti pill for rare blood cancer
- Drug priced at $48,500 per month, competes with Syndax's Revuforj
- Komzifti carries boxed warning for serious side effects
On November 14, 2025, the U.S. Food and Drug Administration (FDA) approved Kura Oncology and Japanese partner Kyowa Kirin's once-daily pill, Komzifti, to treat a rare form of blood cancer. The drug is approved for acute myeloid leukemia patients with an NPM1 mutation, a genetic change found in about 30% of cases.
Kura said Komzifti will be available within the next few business days at a price of $48,500 for a one-month supply. With this approval, Kura's drug now competes with Syndax Pharmaceuticals' Revuforj, which was approved for the same indication by the FDA last month.
However, Komzifti's approval comes with a boxed warning for differentiation syndrome and an additional warning for QTc interval prolongation, a delay in the heart's electrical recovery after a beat, and potential harm to unborn babies. This gives Syndax's Revuforj, which carries a boxed warning for QTc interval prolongation, a significant competitive advantage, according to Wedbush analysts.
