Canada green lights Xospata for acute myeloid leukemia

14 January 2020

The Canadian business of Japanese drugmaker Astellas Pharma (TYO: 4503) has won approval for the oral once-daily therapy Xospata (gilteritinib), for relapsed or refractory acute myeloid leukemia (AML).

The approval relates to people with AML with an FLT3 mutation, a type of tumor against which the novel therapy has the most potential to improve treatment outcomes.

Health Canada granted marketing authorization on the basis of the Phase III ADMIRAL trial, which showed median overall survival (OS) of 9.3 months, compared to 5.6 months for patients who received salvage chemotherapy.

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