In which country is giritinib approved for marketing?

Gilteritinib (trade name: The drug was developed by Astellas Pharma of Japan (Astellas Pharma) and has been approved for marketing in many countries and regions.

In November 2018 November , the U.S. Food and Drug Administration (FDA) took the lead in approving the marketing of giritinib for the treatment of... FDAapproved test confirms the presence of FLT3 mutations in adult patients with relapsed or refractory AML. The approval is based on interim data from the Phase III ADMIRAL clinical trial, which showed that gilitinib has a significant advantage in extending overall survival in patients.

In October 2019October , after an accelerated assessment by the European Medicines Agency (EMA), the European Commission (E C) approved the marketing of gilitinib in EU member states, Iceland, Norway and Liechtenstein for the treatment of adult patients with FLT3 mutation-positive relapsed or refractory AML. The drug was also granted orphan drug status to encourage research into treatments for rare diseases.

In addition, giritinib has been approved in countries including Japan, Canada, Australia and China. Among them, the National Medical Products Administration of China (NMPA) announced in20212Giritinib was conditionally approved in March for the treatment of adult patients with relapsed or refractory FLT3 mutation-positive AML. The approval was based on overseas clinical trial data and accelerated marketing through a priority review process.

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