Posted by Michael Wonder on 02 Jun 2025
Kura Oncology and Kyowa Kirin announce FDA acceptance and priority review of new drug application for ziftomenib in adults with relapsed or refractory NPM1 mutant AML
1 June 2025 - New drug application based on positive results from the Phase 2 KOMET-001 trial.
Kura Oncology and Kyowa Kirin today announced the US FDA has accepted Kura’s new drug application seeking full approval for ziftomenib as a treatment for adult patients with relapsed or refractory acute myeloid leukaemia with a nucleophosmin 1 mutation.
The application has been granted priority review and assigned a PDUFA target action date of 30 November 2025.
