Research & Development
Astellas Pharma Inc unveils XOSPATA for prescription in the US for the treatment of Acute Myeloid Leukemia
11 December 2018 -

Health care company Astellas Pharma Inc (TSE:4503) revealed on Monday the availability of the XOSPATA for prescription in the US for the treatment of adult patients with Acute Myeloid Leukemia (AML), a cancer that impacts the blood and bone marrow and its incidence increases with age.

The company has introduced XOSPATA (generic name: gilteritinib) for prescription in the US for the treatment of adult patients who have relapsed or refractory (resistant to treatment) Acute Myeloid Leukemia (AML) with a FLT3 mutation as detected by an US FDA-approved test.

According to the company, XOSPATA, which is an oral monotherapy, is the first and only FLT3-targeting agent approved by the US FDA for the treatment of relapsed or refractory FLT3 mutation-positive (FLT3mut+) AML.

In Japan, XOSPATA is launched as XOSPATA in 40 mg Tablets for relapsed or refractory AML with FLT3 mutations upon approval by the Japan Ministry of Health, Labor and Welfare (MHLW).

Additionally, the health professionals, patients and their caregivers can get support services for XOSPATA through Astellas at https://www.xospata.com/.

Gilteritinib was discovered through a research collaboration with Kotobuki Pharmaceutical Co Ltd, under which, Astellas is currently investigating gilteritinib in various FLT3 mutation-positive AML patient populations through several Phase 3 trials.

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