U.S. FDA Grants Priority Review to Astellas’ New Drug Application for Gilteritinib for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. "Astellas") announced today that the U.S. Food and Drug Administration (FDA) has accepted, with Priority Review, the company’s New Drug Application (NDA) for gilteritinib for the treatment of adult patients who have relapsed or refractory (resistant to treatment) Acute Myeloid Leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. Currently, there are no FLT3-targeting agents approved for the treatment of relapsed or refractory FLT3 mutation-positive (FLT3mut+) AML.

"FLT3 mutations impact approximately 30 percent of AML patients and are often associated with poor survival outcomes. Many with this condition relapse after treatment or don’t respond to currently available treatments. Simply put, they need more options," said Steven Benner, M.D., senior vice president and global therapeutic area head, Oncology Development, Astellas. "The FDA’s acceptance of this NDA, with Priority Review, represents a significant milestone for gilteritinib and Astellas in our mission to help AML patients and the physicians who treat them."

The NDA is based on the ongoing Phase 3 ADMIRAL trial investigating gilteritinib for the treatment of adult patients with FLT3mut+ relapsed or refractory AML. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is November 29, 2018.

The FDA grants Priority Review designation to applications for drugs that, if approved, may offer significant improvements in the safety and effectiveness of the treatment of serious conditions when compared to standard applications. Under Priority Review, the FDA aims to take action on an application within six months of receipt, as compared to ten months under standard review.

Previously, gilteritinib was granted both Orphan Drug designation and Fast Track designation by the U.S. FDA. Gilteritinib also received Orphan Designation from the European Commission (EC) and Orphan Drug Designation from the Japan Ministry of Health, Labor and Welfare (MHLW). The MHLW also granted SAKIGAKE designation to gilteritinib for relapsed/refractory AML

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