Which pharmaceutical company is responsible for manufacturing Gilteritinib?

Gilitinib is an oral tyrosine kinase inhibitor mainly used to treat patients with relapsed or refractory acute myeloid leukemia (AML) who carry FLT3 mutations. The drug is developed, produced and commercialized globally by Japanese pharmaceutical company Astellas Pharma Inc. Giritinib is the result of cooperative research and development between Astellas and Kotobuki Pharmaceutical Co., Ltd. (Kotobuki Pharmaceutical Co., Ltd.), of which Astellas has exclusive global rights.

The trade name of geritinib isXOSPATA®, which was initially approved by the US Food and Drug Administration in November 2018. Approved by the Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory AML harboring FLT3 mutations. Subsequently, the drug was also approved for marketing in Japan, Europe, Canada, South Korea, Brazil, Australia and other countries and regions. In China, the marketing application for giritinib has been accepted by the National Medical Products Administration (NMPA) and is currently in the review stage.

Giritinib exerts anti-tumor effects by inhibiting tyrosine kinases such as FLT3 and AXL and blocking the growth signals of leukemia cells. It has shown good efficacy and controllable safety in clinical trials, and is especially suitable for patients with FLT3 mutated AML who are refractory to or relapsed with standard chemotherapy. Astellas is currently conducting multiple clinical studies around the world to further evaluate the efficacy and safety of giritinib in different patient groups.

In general, giritinib is an innovative anti-leukemia drug developed and produced by Astellas Pharmaceuticals. It has been approved in many countries and regions and is promoted for use worldwide. For AML patients carrying FLT3 mutations, geritinib provides a new treatment option that significantly improves the prognosis of this high-risk patient group.

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