FDA approves Kura and Kyowa’s Komzifti

The US Food and Drug Administration approved USA-based Kura Oncology (Nasdaq: KURA) and Japan’s Kyowa Kirin’s (TYO: 4151) ziftomenib (trade name Komzifti), a menin inhibitor, for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options.

The news - which came ahead of the FDA Prescription Drug User Fee Act (PDUFA)date of November 30 - pushed Kura’s shares up 8.2% to $9.81 by midday yesterday.

Historically, patients with NPM1-m AML have faced limited treatment options and low survival rates. This approval marks a turning point for AML care, making NPM1 mutations actionable, providing patients with a simple targeted therapy, and positioning Kura as the pioneering leader in menin inhibition.