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Xospata Approved for Acute Myeloid Leukemia With FLT3 Mutation
The FDA has approved Xospata (gilteritinib, Astellas Pharma) tablets for the treatment of adults who have relapsed or refractory acute myeloid leukemia (AML) with an FLT3 gene mutation.
Approximately 19,520 people were diagnosed with AML in 2018, with approximately 10,670 patients dying of the disease this year. Between one-quarter to one-third of patients with AML have an FLT3 mutation, which is associated with a highly aggressive form of the disease and a higher risk of relapse.
The efficiency of gilteritinib was studied in a clinical trial of 138 patients with relapsed or refractory AML and a confirmed FLT3 mutation. Twenty-one percent of patients achieved complete remission or complete remission with partial hematologic recovery (no evidence of disease and partial recovery of blood counts) after treatment with gilteritinib.
Among the common side effects reported by subjects were myalgia/arthralgia, fatigue, and elevated liver transaminase. Health care providers should monitor patients for posterior reversible encephalopathy syndrome, prolonged QT interval, and pancreatitis. Rare cases of differentiation syndrome have been seen in patients taking Xospata. Women who are pregnant or breastfeeding should not take Xospata as it may harm the developing fetus or newborn baby.
The FDA granted gilteritinib fast track, priority review, and orphan drug designations.
Source: FDA, November 28, 2018