TOKYO, Mar 09 (Pulse News Wire) – Astellas Pharma Inc. (4503.T) announced today that the primary endpoint of its Phase III PASHA trial evaluating XOSPATA (gilteritinib) against midostaurin in untreated FLT3-mutated acute myeloid leukemia (AML) patients did not show statistically significant improvement in overall survival (OS).
However, gilteritinib demonstrated similar OS benefits compared to midostaurin. Adverse events and grade 3+ adverse event rates were comparable across treatment groups. The company will continue comprehensive data analysis and collaborate with investigators for future results publication.
The trial was conducted by HOVON Foundation and involved multiple countries. Gilteritinib is approved globally for treating relapsed/refractory FLT3-mutated AML in adults. Despite the failure to meet the primary endpoint, Astellas remains committed to advancing research in FLT3-targeted therapies for AML.
The company expects minimal impact on its fiscal year 2026 earnings.
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