Kura Oncology Gets Breakthrough Designation For Leukemia Therapy

By Ben Glickman

Kura Oncology said Monday it received a breakthrough therapy designation from regulators for ziftomenib, its potential treatment for a form of leukemia.

The San Diego-based biopharmaceutical company said the U.S. Food and Drug Administration had granted ziftomenib the status as a potential treatment for relapsed/refractory NPM1-mutant acute myeloid leukemia.

The FDA's designation will give Kura access to more frequent meetings and communications as well as the potential for quicker approval for the treatment.

Ziftomenib had previously received an orphan drug designation from the FDA.

Kura said it is on track to complete its registration-directed trial for ziftomenib by mid-2024.

AML is expected to affect about 21,000 people in the U.S. this year, according to the American Cancer Society. About 30% of cases are the NPM1-mutant form.

Write to Ben Glickman at ben.glickman@wsj.com

(END) Dow Jones Newswires

April 22, 2024 08:25 ET (12:25 GMT)

Copyright (c) 2024 Dow Jones & Company, Inc.