Astellas Reports NMPA’s Acceptance of NDA for XOSPATA (gilteritinib) to Treat R/R AML with a FLT3 Mutation in Adults

Astellas Reports Results of Mirabegron in P-IV PLUS Study to Reduce Overactive Bladder Symptoms in Men

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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