The U.S. Food and Drug Administration (FDA) recently granted fast track designation to Astellas Pharma to develop gilteritinib, an investigational compound, for patients with FLT3 mutation-positive (FLT3+) relapsed or refractory acute myeloid leukemia (AML).
Astellas said in a release the FDA granting of fast track status for gilteritnib is a step toward more frequent meetings with the FDA and also opens up the possibility of FDA’s consideration of placing the drug under Priority Review.
"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," Astellas Senior Vice President and Global Therapeutic Area Head of Oncology Development Steven Benner said in the release. "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."
The FDA grants fast track designation in an effort to expedite their review of drugs which are targeted to treat serious and life-threatening conditions which can then reach the market faster.
According to Astellas, the company is now investigating gilteritinib in AML patient populations with four Phase 3 trials.
