Quantcast

U.S. FDA fast tracks Astellas’s development of gilteritinib in certain myeloid leukemia

Astellas Pharma will have an expedited review process for gilteritinib, as the U.S. Food and Drug Administration (FDA) granted fast track designation to produce it for adult patients with FLT3 mutation-positive (FLT3+) relapsed or refractory acute myeloid leukemia (AML).

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, senior vice president and global therapeutic area head, oncology development, Astellas.

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.

AML is a cancer that impacts the blood and bone marrow and is most commonly experienced in older adults. According to the American Cancer Society, in 2016 there were approximately 21,000 new patients diagnosed with AML in the United States and about 10,000 cases resulted in death.

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.

Astellas is currently investigating gilteritinib in various AML patient populations through four ongoing Phase 3 trials, including the registrational ADMIRAL trial in relapsed/refractory FLT3+ AML.

Leave a Reply

Your email address will not be published. Required fields are marked *