Date: 13-Apr-2020

Chainese NMPA Accepts Astellas’ NDA For Oral Once-daily Therapy Xospata To Treat Relapsed/refractory AM

Astellas Pharma Inc announced a new drug application (NDA) for the oral once-daily therapy Xospata (gilteritinib), for the treatment of adult patients who have relapsed (disease that has returned) or refractory (resistant to treatment) acute myeloid leukemia (AML) with a FLT3 mutation (FLT3mut+), has been accepted by the National Medical Products Administration (NMPA) for regulatory review in China.
AML is a cancer that impacts the blood and bone marrow, and its incidence increases with age. It is estimated that every year, around 80,000 people in China are diagnosed with leukemia. AML is one of the most common types of leukemia in adults.
AML patients with a FLT3 mutation have a particularly poor prognosis, with a median survival of less than six months following treatment with salvage chemotherapy. The status of FLT3 mutation can change over the course of AML treatment, even after relapse. As such, a patient's mutation status should be determined to help inform the best treatment approach.
Gilteritinib was approved in the US and Japan in 2018, Europe and Canada in 2019, and Korea, Brazil and Australia thus far in 2020 for the treatment of adult patients who have relapsed or refractory FLT3mut+ AML. As of April 2020, gilteritinib is available in the US, Japan and selected countries in Europe.
Gilteritinib is a FMS-like tyrosine kinase 3 (FLT3) and has demonstrated inhibitory activity against FLT3-ITD, a type of FLT3mut+ that is seen in approximately one-third of patients with AML, as well as FLT3-TKD mutation. FLT3-ITD is a common driver mutation that presents with a high burden and poor prognosis.