The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of gilteritinib for adult patients with FLT3 mutation-positive (FLT3+) relapsed or refractory acute myeloid leukemia (AML). Fast Track designation is designed to facilitate the development, and expedite the FDA review, of drugs to treat serious and life-threatening conditions so that, if approved, the compounds can reach the market expeditiously.
Gilteritinib is an investigational compound that has demonstrated inhibitory activity against FLT3 internal tandem duplication (ITD) as well as FLT3 tyrosine kinase domain (TKD), two common types of FLT3 mutations that are seen in approximately one-third of patients with AML. Further, gilteritinib has also demonstrated inhibition of AXL, which is reported to be associated with therapeutic resistance.
AML is a cancer that impacts the blood and bone marrow and is most commonly experienced in older adults. According to the American Cancer, in 2016 there were approximately 21,000 new patients diagnosed with AML in the United States.
“Mutations of FLT3 in AML are associated with a poor prognosis and we are committed to working with the FDA to meet the requirements of the expedited review process,” said Steven Benner, M.D., senior vice president and global therapeutic area head, oncology development, Astellas. “We are pleased that the FDA has acknowledged the urgent need for new therapies for FLT3+ AML patients, which may allow for an expedited review process for gilteritinib.”
Fast Track designation for gilteritinib may allow for more frequent meetings and correspondence with the FDA, consideration for Priority Review if supported by clinical data, and Rolling Review, which means Astellas can submit completed sections of its New Drug Application (NDA) for review by the FDA rather than waiting until every section of the application is completed before the NDA can be reviewed.