LANSING, Mich. (Michigan News Source) — A diagnosis that once offered few options now comes with something doctors rarely had before: time.

The U.S. Food and Drug Administration (FDA) has approved KOMZIFTI, a once-daily leukemia drug rooted in long-running University of Michigan research that targets a key mechanism fueling acute myeloid leukemia (AML)—one of the most aggressive blood cancers doctors treat.

History of the treatment.

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The treatment traces back nearly 20 years to work by U-M scientists Jolanta Grembecka and Tomasz Cierpicki, who set out to answer a basic but risky question: could interrupting a specific protein interaction actually slow leukemia’s growth?

At the time, no one knew.

AML rapidly crowds the bone marrow with malfunctioning white blood cells, leaving patients vulnerable to infections, bleeding, exhaustion and sudden weight loss. While often associated with younger patients, the disease most commonly strikes older adults, and treatment options historically have been limited.

The U-M researchers focused on a protein pathway involving menin, a target few others were exploring. Years of laboratory work followed, including the screening of thousands of compounds before a viable drug candidate emerged.

In 2014, the university licensed the discovery to Kura Oncology, allowing the research to move beyond the lab and into clinical trials. The first human studies began in 2019.

Recent advances.

Recent trial data show the drug—used alongside existing leukemia treatments—helped a large share of newly diagnosed patients reach remission, a result that would have been unlikely not long ago. Additionally, early backing from the American Cancer Society helped sustain the research before commercial interest followed.

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The researchers say approval isn’t the finish line. Leukemia cells can evolve, and work is already underway on next-generation drugs aimed at preventing resistance and expanding treatment options.

“You have to go through hundreds, or in this case probably more than 2,000 molecules,” Grembecka said.