Posted by Michael Wonder on 08 Apr 2025
Kura Oncology and Kyowa Kirin announce submission of new drug application for ziftomenib to FDA
8 April 2025 - Submission seeks approval for the treatment of adult patients with relapsed or refractory AML with a NPM1 mutation.
Kura Oncology and Kyowa Kirin today announced Kura submitted a new drug application for ziftomenib, a highly selective, once-daily, oral, investigational menin inhibitor, for the treatment of adult patients with relapsed or refractory acute myeloid leukaemia with a nucleophosmin 1 (NPM 1) mutation to the US FDA on 31 March 2025.
