Phase III failure for Xospata in AML
A Phase III trial of Xospata (gilteritinib) plus azacitidine versus azacitidine alone in newly diagnosed FLT3 mutation-positive (FLT3mut+) acute myeloid leukemia (AML) patients who were ineligible for intensive induction chemotherapy did not meet its primary endpoint of overall survival at a planned interim analysis of the LACEWING trial.
The drug is under development by Japanese drug major Astellas Pharma (TYO 4503), whose shares initially dropped nearly 2% but recovered to close the day up 0.9% at 1,553 yen.
Termination due to futility recommended
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