Therapeutic Response

NPM1 p.W288Cfs*12 status confers therapeutic sensitivity to Ziftomenib in patients with Acute Myeloid Leukemia.

Statements

Source and description

Komzifti (ziftomenib) [package insert]. FDA. The U.S. Food and Drug Administration (FDA) granted approval to ziftomenib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options. This approval is based on NCT04067336, an open-label, single-arm, multicenter clinical trial of 112 patients where eligibility criteria included NPM1 mutations, including Type A (c.860_863dupTCTG), B (c.863_864insCATG), and D (c.863_864insCCTG) mutations and other NPM1 mutations likely to result in cytoplasmic localization of the NPM1 protein.