New Treatment for AML Led by Roswell Park Expert Earns FDA Approval

A clinical trial for an aggressive form of leukemia, devised and co-led by Eunice Wang, MD, Chief of Leukemia at Roswell Park Comprehensive Cancer Center, was recently approved by the FDA.

Based on a pivotal phase 1/2  KOMET-001 trial, on which Dr. Wang was the global Principle Investigator, the FDA approved using the oral therapy ziftomenib as treatment for adults with acute myeloid leukemia (AML) carrying an NPM1 mutation, found in up to one-third of newly diagnosed patients.

“I am proud to say that Roswell Park patients were the first in the world to be treated with ziftomenib, and we are continuing to advance this development of this drug for AML patients with clinical trials investigating this agent in combination with chemotherapy in the newly diagnosed and relapsed/refractory setting,” says Dr. Wang. 

Clinical trial findings were published in print in November in the prestigious Journal of Clinical Oncology with Dr. Wang  as first author. 

In that study of 92 adults with relapsed or refractory acute myeloid leukemia (AML) carrying an NPM1 mutation, all of whom had received multiple lines of prior therapy, 23% achieved a complete response, demonstrating no evidence of disease after treatment on the study. Dr. Wang and co-authors reported in that publication: “Ziftomenib demonstrated significant clinical benefit and deep responses in patients with heavily pretreated, relapsed/refractory AML,” and Ziftomenib was well tolerated with a safety profile consistent with previous studies.

For more information about the trial, or to determine if a patient with AML could benefit from this treatment, contact us by emailing physicianrelations@roswellpark.org or calling 716-845-RPMD (7763).