XOSPATA (gilteritinib) tablets,
for oral use Initial U.S. Approval: 2018
As specified in the prescribing information, gilteritinib tablets is indicated for the treatment of Leukemia. Xospata (gilteritinib) is a medication used with other medicines to treat adults with FLT3m+ AML when the disease has come back or has not improved after previous treatment(s).
Facts about gilteritinib tablets
Manufacturer-Astellas Pharma Inc.
Medicine Approved By-European Medical Agency (EMA), Food and Drug Administration (FDA), Health Canada, Therapeutic Goods Administration (TGA)
Summary of FDA-approved use on approval date: Click Here
(see Drugs@FDA for complete indication)
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Query For gilteritinib tablets
Approved accessible "gilteritinib tablets"
Gilteritinib, is an anti-cancer drug. It acts as an inhibitor of FLT3, hence it is a tyrosine kinase inhibitor. In April 2018, Astellas filed a new drug application with the Food and Drug Administration for gilteritinib for the treatment of adult patients with FLT3 mutation–positive relapsed or refractory acute myeloid leukemia (AML).
In November 2018, the FDA approved gilteritinib for treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. Gilteritinib was granted orphan drug status by the U.S. FDA, the European Commission (EC) and the Japan Ministry of Health, Labor and Welfare, for some AML patients. Gilteritinib was approved for medical use in Australia in March 2020.
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XOSPATA (gilteritinib) tablets, for oral use Initial U.S. Approval: 2018
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