What is the international approval status of giritinib?

Gilteritinib is a selective FLT3 tyrosine kinase inhibitor developed by Astellas Pharma for the treatment of adult patients with FLT3 mutation-positive acute myeloid leukemia (AML). FLT3 mutation is one of the most common molecular abnormalities in AML and is often closely related to high disease aggressiveness, high recurrence rate, and poor prognosis. Therefore, the development of targeted drugs targeting FLT3 mutations is of great clinical significance. Giritinib selectively inhibits the FLT3 signaling pathway and blocks abnormal hematopoietic signals, thereby promoting the differentiation and apoptosis of diseased leukemia cells, improving hematological indicators and delaying disease progression.

The approval process of giritinib in the international market demonstrates its clinical value and global recognition. In April 2018, the U.S. Food and Drug Administration (FDA) accepted the new drug application for giritinib and approved it through the accelerated approval process for adult patients with relapsed or refractory AML confirmed by genetic testing to have FLT3 mutations.

Subsequently, the European Medicines Agency (EMA) and Japan also approved giritinib for similar indications and granted it orphan drug status, aiming to encourage the development of precision treatments for patients with rare diseases. In March 2020, giritinib was approved for clinical treatment in Australia. In January 2022, giritinib was officially launched in China under the trade name of giritinib fumarate tablets/segatan, providing domestic AML patients with targeted treatment options that are in sync with international standards.

The international approval of giritinib not only means that its efficacy and safety are recognized, but also promotes the precision of globalAML treatment. Clinical practice emphasizes the need for FLT3 gene testing before using giritinib. The drug is an oral preparation, which facilitates long-term management of patients, and is combined with hematology and liver and kidney function monitoring to achieve a balance between efficacy and safety. The background of the international approval of giritinib shows that it is gradually forming a standardized regimen in the global treatment of AML, especially providing new hope for FLT3 mutation-positive patients.

Reference materials:https://www.xospata.com/