Efficacy And SafetyZiftomenib demonstrated a favorable safety profile with no additional myelosuppression, supporting its use in combination with standard treatment for newly diagnosed AML patients.
Market PotentialKURA remains confident in the market potential of ziftomenib in 1L AML, estimating a significant annual peak opportunity for the class in the US.
Regulatory ApprovalFDA acceptance of NDA with Priority Review and a PDUFA date set is seen as a strong indicator of potential approval for ziftomenib.