Astellas Reports NMPA's Acceptance of NDA for XOSPATA (gilteritinib) to Treat R/R AML with a FLT3 Mutation in Adults
Shots:
- Gilteritinib is a FMS-like tyrosine kinase 3 (FLT3) and has inhibitory activity against FLT3-ITD which is a type of FLT3mut+ found in AML patients. Additionally- FLT3-ITD is a driver mutation that demonstrates high burden and poor prognosis
- The candidate is approved in the US and Japan in 2018- EU and Canada in 2019- in Korea- Brazil and Australia thus far in 2020 to treat adults with R/R FLT3mut+ AML. Till now it is available in the US- certain countries of EU and Japan
- In 2018- Astellas and Kotobuki Pharmaceutical collaborated to develop- manufacture and commercialize gilteritinib
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