FDA News

FDA grants fast track designation to gilteritinib for acute myeloid leukemia

The FDA granted fast track designation to gilteritinib for treatment of adults with FLT3 mutation-positive relapsed or refractory acute myeloid leukemia.

Gilteritinib (ASP2215, Astellas) has demonstrated inhibitory activity against FLT3 internal tandem duplication and FLT3 tyrosine kinase domain. These common FLT3 mutations are observed in approximately one-third of patients with AML.

Gilteritinib also has demonstrated inhibition of AXL, which may be associated with therapeutic resistance.

“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,” Steven Benner, MD, senior vice president and global therapeutic area head for oncology development at Astellas, said in a company-issued press release. “We are pleased that the FDA has acknowledged the urgent need for new therapies for FLT3-positive AML patients, which may allow for an expedited review process for gilteritinib.”

Four phase 3 trials are underway to evaluate gilteritinib for various subgroups of patients with AML. The registrational ADMIRAL trial includes patients with relapsed/refractory FLT3-positive AML.

In July, the FDA granted orphan drug designation to gilteritinib for treatment of AML.

The FDA granted fast track designation to gilteritinib for treatment of adults with FLT3 mutation-positive relapsed or refractory acute myeloid leukemia.

Gilteritinib (ASP2215, Astellas) has demonstrated inhibitory activity against FLT3 internal tandem duplication and FLT3 tyrosine kinase domain. These common FLT3 mutations are observed in approximately one-third of patients with AML.

Gilteritinib also has demonstrated inhibition of AXL, which may be associated with therapeutic resistance.

“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,” Steven Benner, MD, senior vice president and global therapeutic area head for oncology development at Astellas, said in a company-issued press release. “We are pleased that the FDA has acknowledged the urgent need for new therapies for FLT3-positive AML patients, which may allow for an expedited review process for gilteritinib.”

Four phase 3 trials are underway to evaluate gilteritinib for various subgroups of patients with AML. The registrational ADMIRAL trial includes patients with relapsed/refractory FLT3-positive AML.

In July, the FDA granted orphan drug designation to gilteritinib for treatment of AML.