Gilteritinib, sold under the brand name Xospata, is an anti-cancer drug.
Mechanism of action
Gilteritinib acts as an
inhibitor
Inhibitor or inhibition may refer to:
Biology
* Enzyme inhibitor, a substance that binds to an enzyme and decreases the enzyme's activity
* Reuptake inhibitor, a substance that increases neurotransmission by blocking the reuptake of a neurotransmi ...
of
FLT3
Cluster of differentiation antigen 135 (CD135) also known as fms like tyrosine kinase 3 (FLT-3 with fms standing for "feline McDonough sarcoma"), receptor-type tyrosine-protein kinase FLT3, or fetal liver kinase-2 (Flk2) is a protein that in human ...
, hence it is a
tyrosine kinase inhibitor
A tyrosine kinase inhibitor (TKI) is a pharmaceutical drug that inhibits tyrosine kinases. Tyrosine kinases are enzymes responsible for the activation of many proteins by signal transduction cascades. The proteins are activated by adding a phosph ...
.
History
Gilteritinib was
developed by
Astellas Pharma
is a Japanese multinational pharmaceutical company, formed on 1 April 2005 from the merger of and .
Astellas is a member of the Mitsubishi UFJ Financial Group (MUFJ) keiretsu.
History Early foundations
Fujisawa Shoten was started in 1894 ...
.
In April 2018, Astellas filed a
new drug application
The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. Some 30% or less of initial ...
with the
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...
for gilteritinib for the treatment of adult patients with
FLT3 mutation–positive (both ITD and TKD) relapsed or refractory
acute myeloid leukemia
Acute myeloid leukemia (AML) is a cancer of the myeloid line of blood cells, characterized by the rapid growth of abnormal cells that build up in the bone marrow and blood and interfere with haematopoiesis, normal blood cell production. Sympt ...
(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
An orphan drug is a medication, pharmaceutical agent that is developed to treat certain rare medical conditions. An orphan drug would not be profitable to produce without government assistance, due to the small population of patients affected by th ...
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.
References
Further reading
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External links
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Pyrazines
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Tyrosine kinase inhibitors
Orphan drugs
Astellas Pharma