Advertisement

FDA Grants Priority Review to Gilteritinib for the Treatment of Relapsed or Refractory FLT3 Mutation–Positive AML

Advertisement

The U.S. Food and Drug Administration (FDA) has accepted, with Priority Review, a new drug application (NDA) for gilteritinib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) and a mutation in the FLT3 gene, 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 AML.

FLT3 mutations impact approximately 30% 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, MD, Senior Vice President and Global Therapeutic Area Head, Oncology Development, Astellas.

The NDA is based on the ongoing phase III ADMIRAL trial investigating gilteritinib for the treatment of adult patients with FLT3 mutation–positive relapsed or refractory AML. The Prescription Drug User Fee Act 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 6 months of receipt, as compared to 10 months under standard review.

Previously, gilteritinib was granted both Orphan Drug designation and Fast Track designation by the FDA. Gilteritinib also received Orphan designation from the European Commission and Orphan Drug designation from the Japan Ministry of Health, Labor and Welfare (MHLW). The MHLW also granted SAKIGAKE designation (ie, a policy aimed at the early introduction of innovative medicines and medical devices that are initially developed in Japan) to gilteritinib for relapsed or refractory AML. 

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


Advertisement

Advertisement



Advertisement