Xospata (gilteritinib) from Astellas Pharma is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test.
In March, Astellas announced that the drug met its primary endpoint in a planned interim analysis of a Phase 3 confirmatory trial for patients with relapsed or refractory FLT3 mutation-positive (FLT3mut+) acute myeloid leukemia (AML).
The study, known as COMMODORE, is comparing Xospata to salvage chemotherapy in adult patients.
Overall, the drug has been the subject of 33 trials to date. Astellas has discontinued trials for non-small cell lung cancer and solid tumors.
Filed Under: Hematology, Oncology
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